Improving ocular surface comfort in contact lens wearers

PurposeContact lens discomfort (CLD) is a major concern that can lead to the decreased or abandoned use of contact lenses. Contact lens users with dry eye disease are more likely to present with CLD. This study was conducted to evaluate the efficacy of a bioprotective preservative free, hypotonic, 0.15% hyaluronic acid (HA)-3% Trehalose artificial tear in managing dry eye symptoms in contact lens wearers.MethodsA prospective, single-arm, observational pilot study to evaluate the effectiveness of treatment with HA-Trehalose artificial tears in contact lens wearers (N = 33) aged 18–45 years with symptoms of ocular discomfort. Participants used a preservative-free, hypotonic HA-Trehalose artificial tear (1 drop/4 times per day) for 84 days. Participants were assessed using Visual Analogue Scale (VAS) for dry eye symptoms (pain, photophobia, dry eye sensation, blurry vision, foreign body sensation, itching, tingling/burning, and sticky eye feeling), Ocular Surface Disease Index (OSDI), Contact Lens Dry Eye questionnaire (CLDEQ-8), Berkley Dry Eye Flow-Chart (DEFC) on Day 0 and Day 84 and tear break-up time (TBUT), ocular surface staining with fluorescein and lissamine green, tear meniscus evaluation, and visual acuity on Day 0, 35, and 84.ResultsAll VAS symptoms (except tingling/burning and sticky eye feeling), OSDI, CLEDQ-8, and DEFC showed statistically significant (p < 0.05) improvement from baseline (Day 0) to Day 84. Similarly, corneal (fluorescein) and conjunctival (lissamine green) quality improved during the study (p < 0.05 at Day 84 versus baseline). Tear break-up time (TBUT), conjunctival (lissamine green) staining, and tear meniscus decreased but the changes were not statistically significant. Visual acuity did not change during the study. There were no ocular or systemic adverse events.ConclusionsThis study showed that the instillation of a preservative-free, hypotonic, HA-Trehalose artificial tear in contact lenses wearers with dry eye syndrome significantly improved symptoms and reduced associated signs such as corneal and conjunctival staining.     

Assessment of condition-induced changes on the ocular surface using novel methods to assess the tear film dynamics and the lipid layer

ObjectivesTo assess the effects of different condition-induced changes on current and novel ocular surface metrics.MethodsEighty-four healthy volunteers (22.4 ± 2.6 years) participated in this study. The ocular surface and tear film response to (1) computer use, (2) contact lens insertion and (3) tear film instillation during computer use with contact lenses were assessed. Current metrics included the ocular surface disease (OSDI) questionnaire, 5-item dry eye questionnaire (DEQ-5), bulbar redness, tear meniscus height (TMH) and non-invasive keratograph break-up time (NIKBUT). Novel metrics included the lipid layer thickness obtained from the intensity of the reflected Placido disk and the speed of tear film particles post-blink.ResultsHigher dry eye symptoms, TMH and bulbar redness, and lower values in metrics related to the intensity of the Placido disk pattern and to particle speed were found after the computer reading task (p < 0.036). When a contact lens was fitted, lower TMH, NIKBUT and particle speed metrics were obtained (p < 0.044). Mixed ANOVA revealed that artificial tears significantly ameliorated the effect of computer reading on OSDI, DEQ-5, NIKBUT, metrics related to the intensity of the Placido disk pattern and metrics related to particle speed (p < 0.033).ConclusionsComputer use and contact lens wear worsened dry eye signs and symptoms, but artificial tears ameliorated this effect. Newly developed methods can serve as a tool to detect changes in the tear film triggered by different ocular surface-disturbing conditions.     

The effect of thermo-mechanical device (Tixel) treatment on evaporative dry eye disease – A pilot prospective clinical trial

PurposeTo examine the effects of treatment with a thermomechanical skin device to the eyelid area on the clinical signs and symptoms of patients who suffer from dry eye disease (DED) secondary to meibomian gland dysfunction (MGD).MethodsForty patients aged 45 years or older with DED due to MGD were recruited. Both eyes (n = 80) of each patient received three treatments with the Tixel device (Novoxel®, Israel), with each treatment separated by a 2-week period. Treatment was applied across the upper and lower eyelids, with the same intensity, tip protrusion distance, and contact duration. Two additional follow-up visits were performed at 2-week intervals after treatment cessation. DED status was evaluated during each visit via SPEED II questionnaire, tear break-up time (TBUT), corneal staining score (CSS), MGD score, and frequency of lubricant use. Visual acuity (VA) was recorded during first and last visits.ResultsMean age was 64.3 ± 12.4 years and 72.5 % (n = 29) were female. 45 % (n = 18) had a history of blepharitis, 12.5 % (n = 5) had chalazia, and 17.5 % (n = 7) suffered from allergic conjunctivitis. Mean follow-up time was 2.1 ± 0.6 months. Comparing the first and last visits, all parameters showed significant improvement after Tixel treatment: mean SPEED II scores (16.5 ± 5.9 to 11.8 ± 6.7, p < 0.001), CSS (2.0 ± 1.3 to 0.5 ± 0.9, p < 0.001), TBUT (2.7 ± 0.8 s to 6.5 ± 2.2 s, p < 0.001), MGD score (2.7 ± 0.5 to 1.2 ± 0.4, p < 0.001), and rate of lubricant use (3.4 ± 2.4 per day to 1.9 ± 2.0, p < 0.001). VA also improved (0.10 ± 0.11 logMAR to 0.08 ± 0.10 logMAR, p < 0.05). No major side effects were observed.ConclusionsIn this pilot study Tixel treatment induced significant improvement of signs and symptoms among patients with DED due to MGD. Benefits persisted for at least one month. Further randomized controlled double-blinded studies are needed.     

Efficacy of artificial tears containing trehalose and hyaluronic acid for dry eye disease in women aged 42–54 versus ≥ 55 years

Background and objectivesDry eye disease (DED) is common in postmenopausal women. This study evaluated efficacy of a 3-month daily treatment with artificial tears containing trehalose and hyaluronic acid (HA) in women aged 42–54 years (mixed-hormonal status) versus ≥ 55 years (postmenopausal) and with moderate and severe DED.MethodsThis was a post-hoc analysis of three clinical trials assessing the efficacy of artificial tears containing trehalose (3%) and HA (0.15%) in women with an Ocular Surface Disease Index (OSDI) ≥ 18. Patients instilled one drop of the artificial tears in each eye 3 to 6 times daily and were evaluated at baseline and after 84 ± 7 days for DED symptom severity (OSDI), hyperemia (McMonnies scale), tear break-up time (TBUT), corneal and conjunctival staining (Oxford and Van Bjisterveld scales), tear production (Schirmer I test), and ocular symptoms.ResultsA total of 273 women were evaluated, 61 of age 42–54 years; 212 of ≥ 55 years. DED symptoms, as measured by the OSDI, decreased significantly with the treatment in both age groups (p < 0.0001). Conjunctival hyperemia decreased significantly and TBUT increased significantly in both groups, especially in women of age 42–54 (both p < 0.0001). The global (corneal and conjunctival) staining score decreased significantly in both groups, but also more in women of age 42–54 years. No differences were observed between age groups for any of the variables measured, except for visual acuity. DED symptoms were consistently reported more frequently by the mixed hormonal status women, but also the effect of the treatment was more pronounced in this group.ConclusionsArtificial tears with trehalose and HA significantly improved the symptoms of DED in women aged 42–54 and ≥ 55 years. The decrease in symptoms was more pronounced in women of age 42–54 years, suggesting better mechanisms of recovery from inflammation and loss of ocular surface homeostasis.     

The role of ethnicity versus environment in tear film stability: A pilot study

PurposeExisting literatures suggest a difference in tear film stability between Caucasian and Asian ethnic groups. However, such a finding was compounded by the fact that the comparison was done on subjects living in different environments. Therefore, it is not clear whether such difference is due to ethnicity, environment, or both. The aim of this study is to clarify the roles of these two factors.MethodsA total of 88 asymptomatic subjects participated in this present study. For each subject, the tear film break-up time (TBUT), non-invasive TBUT (NITBUT) and tear meniscus height (TMH) were measured. To isolate the effect of ethnicity, the results of 12 American Asian young adults were compared against the results of 23 Caucasian adults. Both groups were recruited from Nova Southeastern University. To elucidate the effect of environment, the results from the same 12 American Asians were compared to that of the 53 Asian young adults recruited from the Tianjin Vocational Institute, China (Tianjin Asian).ResultsThe tear film stability did not show significant difference among American Asian subjects and Caucasian subjects in TBUT (10.49 ± 2.86 s vs. 11.06 ± 2.79 s,p = 0.57), NITBUT (11.19 ± 4.89 s vs. 11.14 ± 6.20 s, p = 0.98), and TMH (0.21 ± 0.08 mm vs. 0.22 ± 0.05 mm, p =0.59). However, the tear film stability was significantly better in the American Asian group than the Tianjin Asian group in TBUT (10.49 ± 2.86 s vs. 7.60 ± 3.26 s, p = 0.01), NITBUT (11.19 ± 4.89 s vs. 8.03 ± 3.56 s, p = 0.01), and TMH (0.21 ± 0.08 mm vs. 0.14 ± 0.03 mm, p < 0.01).ConclusionsThe previously reported difference in Caucasian and Asian populations might be due to the fact that the studied subjects have different living environments.     

Tear-film evaporation flux and its relationship to tear properties in symptomatic and asymptomatic soft-contact-lens wearers

PurposeWith soft-contact-lens wear, evaporation of the pre-lens tear film affects the osmolarity of the post-lens tear film and this can introduce a hyperosmotic environment at the corneal epithelium, leading to discomfort. The purposes of the study are to ascertain whether there are differences in evaporation flux (i.e., the evaporation rate per unit area) between symptomatic and asymptomatic soft-contact-lens wearers, to assess the repeatability of a flow evaporimeter, and to assess the relationship between evaporation fluxes, tear properties, and environmental conditions.MethodsClosed-chamber evaporimeters commonly used in ocular-surface research do not control relative humidity and airflow, and, therefore, misestimate the actual tear-evaporation flux. A recently developed flow evaporimeter overcomes these limitations and was used to measure accurate in-vivo tear-evaporation fluxes with and without soft-contact-lens wear for symptomatic and asymptomatic habitual contact-lens wearers. Concomitantly, lipid-layer thickness, ocular-surface-temperature decline rate (i.e., °C/s), non-invasive tear break-up time, tear-meniscus height, Schirmer tear test, and environmental conditions were measured in a 5 visit study.ResultsTwenty-one symptomatic and 21 asymptomatic soft-contact-lens wearers completed the study. A thicker lipid layer was associated with slower evaporation flux (p < 0.001); higher evaporation flux was associated with faster tear breakup irrespective of lens wear (p = 0.006). Higher evaporation flux was also associated with faster ocular-surface-temperature decline rate (p < 0.001). Symptomatic lens wearers exhibited higher evaporation flux than did asymptomatic lens wearers, however, the results did not reach statistical significance (p = 0.053). Evaporation flux with lens wear was higher than without lens wear but was also not statistically significant (p = 0.110).ConclusionsThe repeatability of the Berkeley flow evaporimeter, associations between tear characteristics and evaporation flux, sample-size estimates, and near statistical significance in tear-evaporation flux between symptomatic and asymptomatic lens wearers all suggest that with sufficient sample sizes, the flow evaporimeter is a viable research tool to understand soft-contact-lens wear comfort.     

Visual function,ocular surface integrity and symptomatology of a new extended depth-of-focus and a conventional multifocal contact lens

PurposeTo evaluate visual function, ocular surface integrity and dry eye symptoms with an extended depth-of-focus (EDOF) design and a conventional multifocal (MF) contact lens (CL) after 15 days of wear.MethodsA crossover single mask randomised clinical trial was conducted including 30 presbyopes who used an EDOF and a conventional MF CL (Biofinity MF) for 15 days each. Defocus curves, depth-of-focus range, contrast sensitivity (CS) under photopic and mesopic conditions (with and without glare) and subjective perception of halos and glare were evaluated. The ocular surface was evaluated through non-invasive Keratograph tear breakup time (NIKBUT), averaged tear breakup time (NIKBUT-avg), tear meniscus height (TMH), bulbar and limbal redness, and conjunctival and corneal staining. Dry eye symptoms were assessed with the OSDI questionnaire.ResultsNo statistically significant differences were found for defocus curves or depth-of-focus between the two CLs (both p > 0.05). Subjective perception of halos and glare was not significantly different between CLs. Statistically significant differences were observed for CS under mesopic conditions for low spatial frequencies (p = 0.008). None of the CL produced significant changes in NIKBUT, NIKBUT-avg, TMH or redness. No change in conjunctival staining was observed in 76.7 % and 73.3 % of participants for EDOF and Biofinity MF, respectively. No change in corneal staining was observed in 86.7 % and 83.3 % of participants for EDOF and Biofinity MF, respectively. No changes were observed in the symptomatology measured with OSDI questionnaire (p > 0.05).ConclusionsBoth CL for presbyopia offer good visual quality, preserve the ocular surface integrity and provide the patient with similar symptomatology levels after 15 days of lens wear.     

Effect of overnight orthokeratology lenses on tear film stability in children

PurposeTo assess the tear film surface quality after orthokeratology using an automated Medmont E300 corneal topographer.MethodsChildren who wore orthokeratology lenses for more than one year were selected in this retrospective study. Tear film disruption (TFD) and central tear film disruption (cTFD) were measured with Medmont E300 corneal topographer at initial and each follow-up visit after fitting with orthokeratology lenses, providing a nominal value from 0 (perfect) to 1 (poor). Tear film surface quality before and after ortho-k treatment was compared.Results145 children using orthokeratology lenses were observed. TFD and cTFD significantly increased at 1-day follow up (TFD, t = -17.3, P < 0.001; cTFD, t = -10.4, P < 0.001). This change remained consistent through to 12-months visit (TFD, F = 51.1, P < 0.001; cTFD, F = 28.0, P < 0.001). A sub-group of n = 11 children were discontinued for 1-month before being refit with OrthoK lenses of a different design. Similarly, there was a significant increase in TFD compared to pre-orthoK scans (0.172 ± 0.161), but this returned to baseline levels after ceasing lens wear (0.084 ± 0.059). A sub-group of monocular OrthoK wearers (n = 23) found that TFD and cTFD values increased in eyes with monocular lens-wearing but remained stable in the lateral eyes.ConclusionsObjective measurements of tear-film quality are reduced in children after fitting with orthokeratology lenses, but return to baseline after 1-month of lens cessation. It is of importance to ensure tear film surface quality is continuously monitored throughout use of orthoK lenses.     

The influence of overnight orthokeratology on ocular surface and dry eye-related cytokines IL-17A,IL-6, and PGE2 in children

ObjectiveTo investigate the effect of overnight orthokeratology (OOK) on the ocular surface and dry eye-related cytokines in children.MethodsA non-randomized, prospective pilot study was conducted including sixty myopes treated with OOK and sixty age-matched spectacle wearing participants. The following tests were performed before and after 1, 3, 6 and 12 months: ocular surface disease index (OSDI), noninvasive tear breakup time (NITBUT), tear meniscus height (TMH), corneal fluorescein staining (CFS), meiboscore using noncontact meibography. Then the concentrations of interleukin-17A (IL-17A), interleukin-6 (IL-6), and prostaglandin E2 (PGE2) in tear samples were detected with a multiplex immunobead assay at different time points.ResultsAll parameters had no statistical differences between the two groups prior to treatment. No adverse events were observed except trace to moderate corneal staining and allergic conjunctivitis in the treatment group. NITBUT significantly decreased after 6 and 12 months OOK wearing (P = 0.003 and P = 0.001, respectively). After wearing OOK there was a significant increase in CFS at each follow-up time point compared with baseline (P = 0.023, P = 0.016, P = 0.001, and P < 0.001at 1, 3, 6, and 12 months, respectively). The upper meiboscore and the total meiboscore increased gradually and peaked at 12 months of OOK (both P < 0.001). The concentration of the three cytokines in the treatment group significantly increased after OOK wearing. These increases occurred at different time points: IL-17A increased significantly 3 months after OOK, IL-6 at 6 months, and PGE2 at 12 months (all P < 0.001). However, there were no significant changes in the above parameters in the control group. There were no significant differences in the OSDI or TMH at any follow-up time point compared to baseline in both groups (both P > 0.05).ConclusionsShort-term OOK may reduce the stability of the tear film and increase damage to the corneal epithelium. Long-term OOK could induce ocular inflammation through the disruption of meibomian glands.     

Corneal surface wettability and tear film stability before and after scleral lens wear

PurposeThe aim of this study was to evaluate the anterior surface of scleral contact lens and ocular surface wettability before and after one-month of scleral lens wear in patients with keratoconus.MethodsForty-nine patients with keratoconus (36.26 ± 9.03 years) were recruited. The sample was divided into two groups: patients with intrastromal corneal ring (KCICRS group) and patients without ICRS (KC group). TFSQ, Schirmer I test, Ocular Surface Disease Index (OSDI questionnaire), tear break-up time (TBUT) and corneal staining were evaluated in two different visits: Baseline (before lens wear) and one-month visit (10 min after lens removal). Visual Analog Scale (VAS questionnaire) was filled in just after inserting the lenses and just before removing them. TFSQ mean and inferior were evaluated over the contact lens surface at the moment of inserting the lens (baseline visit) and after 8 h of lens wear (one-month visit).ResultsAnterior corneal surface TFSQ values increased in all groups after scleral lens wear (p < 0.05). However, there were no statistical differences found at the moment of inserting or after 8 h of lens wear on previous contact lens surface TFSQ (p > 0.05). No changes were found in tear volume for total and in KC and KCICRS groups (p > 0.05). For all groups, there was a statistical decrease of TBUT (p < 0.05). In addition, OSDI score, corneal staining and VAS score improved after scleral lens wear from baseline in total and in both KC and KCICRS groups (p < 0.05).ConclusionThe scleral contact lens surface keeps its wettability after one-month of wear. However, the wettability of the ocular surface is worse after contact lens wearing.     

The ocular surface status in individuals having long-term exposure to ionizing X-radiations

PurposeThe present investigation was done to assess the status of tear film and corneal topography in individuals with long-term exposure to X-ray.MethodThis historical cohort study was carried out to compare the lacrimal and corneal findings between radiographers (n = 126) and non-radiographers (n = 172). Radiographers included individuals with at least 5 years of experience in radiography while subjects in the control group had no history of exposure to X-ray. The Ocular Surface Disease Index (OSDI) was filled out by all individuals. Besides, the Pentacam imaging of both eyes was done. Finally, the lacrimal tests including tear break-up time and Schirmer (with anesthesia) were performed for both eyes of the participants.ResultsThe mean values of the Schirmer and Tear breakup time (TBUT) in the radiographer group (Schirmer: 11.1 ± 3.2 mm, TBUT: 11.3 ± 4.1 s) were significantly lower than the values in control group (14.6 ± 8.1 mm, TBUT: 12.8 ± 4.8 s) (P < 0.0001). The mean OSDI score of the radiographers was significantly higher compared to the control group (24.1 ± 17.6, and 12.3 ± 12.4 respectively (P < 0.0001)). The corneal thickness in the center, inferior, superior, temporal and nasal parts was significantly higher in radiographers versus the control group. In addition, the maximum thickness difference was observed in temporal part (34.00 μm thicker) (P < 0.0001). On the other hand, the corneal eccentricity factor was lower in radiographers compared to the control group (P < 0.0001).ConclusionBased on the findings of this study, it is concluded that the radiographers have thicker and flatter corneas are than the corneas of the subjects in the control group. However, their corneas had no irregularities. Regarding the tear point, a higher prevalence of dry eye symptoms was observed in the radiographers compared to the control group.     

The effect of non-ablative thermomechanical skin treatment (Tixel®) on dry eye disease: A prospective two centre open-label trial

PurposeTo determine the effects of a thermo-mechanical action-based peri-orbital fractional skin treatment (Tixel®) on dry eye disease.MethodsThis prospective, controlled, open labelled study was conducted at two study centres: Midland Eye, Solihull, UK, and Vallmedic Vision, Andorra. Participants were screened at the baseline visit (visit-1), received three Tixel® treatments at 2-weeks intervals including further assessment (visits 2, 3 and 4). Participants were followed up for three months post-treatment (visit 5). Vision, intraocular pressure (IOP), dry eye symptomatology were assessed, including the Ocular Surface Disease Index (OSDI) questionnaire, non-invasive tear break-up time (NIBUT) and tear osmolarity as well as detailed ophthalmic assessments.ResultsSeventy-four participants (41 in Birmingham and 33 in Andorra) with periorbital wrinkles and moderate to severe dry eye disease (DED) were enrolled. The mean age was 59.3 ± 13.3 years and 57 were females. No adverse events, no change in vision (p = 0.310) or IOP (p = 0.419) were observed. Tixel treatment was associated with clinically and statistically significant improvement in the DED symptoms, which was supported by a reduction of 21.40 ± 15.08 (P < 0.001) of the OSDI index. Non-invasive tear break-up time improved by 2.10 ± 0.91 s (p < 0.001) in the Birmingham cohort and 6.60 ± 2.13 s (p < 0.001) in the Andorra cohort. Tear osmolarity reduced from 299.8 ± 13.3 mOsm/L to 298.8 ± 15.6 mOsm/L following the Tixel treatment (p = 0.271).ConclusionsThermo-mechanical action-based peri-orbital fractional skin treatment Tixel® could be an attractive, safe and effective treatment for DED. This treatment is associated with high clinical and statistically significant improvement in DED signs and symptoms with no adverse events.     

Is soft toric contact lenses fitting a feasible option to improve optical quality and visual performance in corneal ectasia?

ObjectivesTo assess the feasibility of fitting soft toric contact lenses (STCL) in corneal ectasias and their impact on optical quality and visual performance.MethodsA total of 22 eyes were fitted with a molded STCL: 11 eyes/9 subjects with corneal ectasia and 11 healthy eyes/11 subjects. Wavefront aberrations were analyzed using a Hartmann-Shack aberrometer. Visual performance was measured under photopic (85 cd/m 2) and mesopic (≤3 cd/m 2) conditions. High-(96 %) and low- (10 %) contrast VA (HCVA and LCVA respectively) were assessed using the ETDRS charts and contrast sensitivity (CS) using the Pelli-Robson chart.ResultsAfter STCL fitting in the ectatic corneas, oblique astigmatism increased 0.15±0.17 μm and 0.34 ± 0.36 μm for 3 mm- and mesopic pupil diameters, respectively.Mean defocus decreased 1.41 ± 0.36 μm and 2.17 ± 0.85 μm for the same pupil diameters. More positive values of vertical coma were found with a change of 0.05 ± 0.06 μm and 0.12 ± 0.10 μm for 3 mm and mesopic pupil diameters, respectively. Comparing changes between both groups, with a 3 mm pupil aperture, statistically significant differences (p < 0.05) were detected in oblique astigmatism, defocus, vertical secondary trefoil and horizontal secondary coma. In the group with corneal ectasia, photopic HCVA and LCVA improved 0.09 ± 0.11 logMAR and 0.12 ± 0.15 logMAR respectively. In mesopic conditions, HCVA, LCVA and CS improved 0.11 ± 0.12 logMAR, 0.18 ± 0.15 logMAR and 0.11 ± 0.07 log. units, respectively.ConclusionsThe analyzed molded soft toric contact lens is a feasible option for good vision in corneal ectasia with moderate irregularity and negative vertical coma.     

Comparison study of two different topical lubricants on tear meniscus and tear osmolarity in dry eye

PurposeTo compare the effect of single-drop administration of two different ophthalmic solutions on tear meniscus and tear osmolarity in patients with mild to moderate dry eye disease.MethodsThis prospective study comprised of 122 patients with mild to moderate dry eye disease. These patients received a single dose of either unpreserved trehalose 3%, hyaluronic acid 0.15%, carbomer 0.25% (THHA, Thealoz Duo Gel) (Group 1) or hyaluronic acid 0.3% (HA) (Group 2) gel-based lubricants. Tear meniscus (height and depth) were measured using anterior segment optic coherence tomography (AS−OCT) at baseline and 10, 60, 120, and 240 min. after instillation. Tear osmolarity, Schirmer I test, tear break-up time (TBUT), gel properties, and patient comfort were evaluated 240 min. after instillation.ResultsTear meniscus height (TMH) and tear meniscus depth (TMD) showed a significant increase with both lubricants compared to the baseline (p < 0.001). This effect remained significant for up to 60 min. and 120 min. for the THHA and HA 0.3% solutions, respectively (p < 0.05, for both). Mean comfort duration was 115.1 ± 20.1 min. in Group 1 and 148.3 ± 49.0 min in Group 2 (p < 0.001). Tear osmolarity, Schirmer I test, and TBUT were similar between the baseline and 240 min. for each group.ConclusionsThe results of this study demonstrate that 0.3% HA remains on the ocular surface for longer than TH-HA. The longer ocular residency time also seems to correlate with a longer patient comfort duration.     

Short-term tolerability of commercial eyelid cleansers: A randomised crossover study

PurposeTo evaluate the short-term tolerability of five commercially available anti-demodectic eyelid cleansers; OCuSOFT Oust Demodex (OD), I-MED I-Lid’n Lash Plus (ILL+), Labtician BlephaDex (BD), Chrissanthe Eye Cleanse (EC), and Théa Blephademodex (BDdx).MethodsThirty healthy non-contact lens wearers (18 female; mean ± SD age, 33 ± 12 years) were enrolled in a prospective randomised crossover study. On separate visits, spaced at least 48 h apart, participants were randomised to receive topical application of one of five eyelid cleansers or saline. Participants rated subjective ocular discomfort during the 10-minute post-application period. Visual acuity, non-invasive tear film stability, conjunctival hyperaemia, and ocular surface staining were assessed at baseline and 10 min.ResultsNo inter-group differences in ocular parameters were noted at baseline (all p > 0.05). Ocular discomfort scores significantly exceeded baseline scores for 60 s following BD application, 120 s with OD, 135 s with BDdx, 150 s with ILL+, and 195 s with EC (all p < 0.05). Deterioration in non-invasive tear film stability, limbal conjunctival hyperaemia, as well as corneal, conjunctival, and lid margin staining was detected following EC application (all p < 0.05), and increased bulbar conjunctival hyperaemia was observed following both EC and ILL+ treatment (both p < 0.05).ConclusionsStudy outcomes highlight varying tolerability profiles with different anti-demodectic lid cleanser preparations, and the potential to induce tear film instability, conjunctival hyperaemia and ocular surface staining on application. Awareness of possible adverse effects arising from topical application of commercial anti-demodectic lid cleanser formulations may help clinicians set realistic patient expectations and encourage better compliance in their use of lid hygiene therapies.     

Evaluation of an enhanced viscosity artificial tear for moderate to severe dry eye disease: A multicenter,double-masked,randomized 30-day study

PurposeIn a randomized, controlled clinical trial, two lubricant artificial tear formulations with enhanced viscosity were compared: an investigational product at the time, containing carboxymethylcellulose 1.0% and glycerin 0.9% (CMC-GLY) with osmoprotectants, and a standard formula containing carboxymethylcellulose 1.0% alone (CMC).MethodsThis double-masked study recruited patients with moderate to severe dry eye at 10 US centers. After a 7-day run-in with CMC 0.5% (Refresh Tears) patients were randomized to use either CMC-GLY or CMC as needed, but at least 2 times daily for 30 days. Patients were stratified by Ocular Surface Disease Index^© (OSDI) score into moderate (23–32) and severe (> 32–65) subgroups. Assessments included OSDI (primary efficacy variable), corneal and conjunctival staining, tear break-up time (TBUT), symptom surveys, and safety variables. Study visits were days 1 (baseline/randomization), 7, and 30.ResultsA total of 188 patients (94 CMC-GLY, 94 CMC) were enrolled. The severe subgroup had 67 CMC-GLY and 65 CMC patients. OSDI scores progressively improved and were similar at day 30 between treatment groups. At day 7, only the CMC-GLY group demonstrated significant improvements from baseline in OSDI score (all patients p < 0.001, severe p < 0.001), corneal staining (p = 0.004), and TBUT (p < 0.001). Between-group dose frequency for CMC-GLY was lower at day 7 (p = 0.031). Other efficacy results were similar between groups. The most commonly reported adverse event in both groups was blurred vision.ConclusionsOverall, the CMC-GLY artificial tear formulation was as effective as the CMC formulation. CMC-GLY demonstrated improvements at an earlier stage (day 7). Both artificial tear formulations were safe and well tolerated, with no treatment-related serious adverse events. These results support the use of the CMC-GLY artificial tear formulation as an effective treatment to reduce the symptoms and signs of dry eye disease.     

Changes in tear film,corneal topography,and refractive status in premenopausal women during menstrual cycle

PurposeTo investigate the changes in a questionnaire based subjective symptomatology, tear film break-up time, tear volume, corneal topography, and refractive status in premenopausal women during menstrual cycle.MethodsSeventeen premenopausal females and 15 healthy males were enrolled in this prospective study. After routine ophthalmologic examination, an ocular surface disease index questionnaire was administered, tear film break-up time (TBUT), and Schirmer I tests were performed. Keratometry readings and refractive status were also obtained. All examinations were repeated at day 21, day 12 and day 2.ResultsOSDI score in day 21 was significantly lower than that in day 12 (p = 0.004) and day 2 (p = 0.01) in the female patients; however, no significant change was found in the male subjects (p > 0.05). No statistically significant difference was found in TBUT and Schirmer I tests, keratometry, and refraction results in both of the female and male subjects at all of the test points (p > 0.05). There was a significant correlation between OSDI score and TBUT (p = 0.02, p = 0.03, respectively), and Schirmer I test at day 12 (p = 0.004, p = 0.008, respectively). A significant negative correlation was found between oestrogen level and horizontal keratometry values at day 21 (r = −0.5, p = 0.03; r = −0.4, p = 0.04, respectively) for the right and left eyes in the female subjects.ConclusionOur study confirms that fluctuations in the blood levels of oestrogen produce alterations in ocular surface equilibrium during the menstrual cycle and consequently affect the subjective dry eye symptoms in female patients. However, no ocular surface parameter changes were observed.     

The influence of overnight orthokeratology and soft contact lens on the meibomian gland evaluated using an artificial intelligence analytic system

PurposeTo test the changes of meibomian gland (MG) morphology using an artificial intelligence (AI) analytic system in asymptomatic children wearing overnight orthokeratology (OOK) and soft contact lens (SCL).MethodsA retrospective study was conducted including 89 participants treated with OOK and 70 participants with SCL. Tear meniscus height (TMH), noninvasive tear breakup time (NIBUT), and meibography were obtained using Keratograph 5 M. MG tortuosity, height, width, density, and vagueness value were measured using an artificial intelligence (AI) analytic system.ResultsIn an average of 20.80 ± 10.83 months follow-up, MG width of the upper eyelid significantly increased and MG vagueness value significantly decreased after OOK and SCL treatment (all P < 0.05). MG tortuosity of the upper eyelid significantly increased after OOK treatment (P < 0.05). TMH and NIBUT did not differ significantly pre- and post- OOK and SCL treatment (all P > 0.05). The results from the GEE model demonstrated that OOK treatment positively affected MG tortuosity of both upper and lower eyelids (P < 0.001; P = 0.041, respectively) and MG width of the upper eyelid (P = 0.038), while it negatively affected MG density of the upper eyelid (P = 0.036) and MG vagueness value of both upper and lower eyelids (P < 0.001; P < 0.001, respectively). SCL treatment positively affected MG width of both upper and lower eyelids (P < 0.001; P = 0.049, respectively) as well as MG height of the lower eyelid (P = 0.009) and tortuosity of the upper eyelid, (P = 0.034) while it negatively affected MG vagueness value of both upper and lower eyelids (P < 0.001; P < 0.001, respectively). However, no significant relationship was found between the treatment duration and TMH, NIBUT, MG morphological parameters in OOK group. SCL treatment duration negatively affected MG height of the lower eyelid (P = 0.002).ConclusionsOOK and SCL treatment in asymptomatic children can influence MG morphology. The AI analytic system may be an effective method to facilitate the quantitative detection of MG morphological changes.     

Diagnostic accuracy of non-invasive tear film break-up time assessed by the simple manual interferometric device

AimTo determine the diagnostic accuracy of non-invasive tear film break-up time (NIBUT) measured by the handheld lipid layer examination instrument.Methods108 patients were enrolled in this cross-sectional study and divided into two groups: patients with dry eye (n = 57) categorized by the presence of dry eye symptoms obtained by Schein Questionnaire and minimally-one objective dry eye sign (tear film break-up time <10 s or corneal, conjunctival and lid margin fluorescein staining), and healthy subjects (n = 51).ResultsDry eye subjects had significantly shorter NIBUT than healthy subjects (6 s vs 20 s, p < 0.001). Logistic regression analysis showed that shorter NIBUT values were excellent indicators of dry eye disease (p < 0.001), with consistency and no significant difference between measurements, even after standardizing the results for age and sex. NIBUT cut-off point to distinguish dry eye from healthy subjects was 12 s (sensitivity 90.2 %, specificity 88.5 %, PPV 92.5 %, NPV 85.2 %, LR +7.82, LR− 0.11, DOR 70.92, DE 89.6 %). Good, but lower accuracy was observed at cut-off value of 10 s (sensitivity 87.8 %, specificity 88.5 %, PPV 92.3 %, NPV 82.1 %, LR+ 7.61, LR− 0.14, DOR 55.2, DE 88.1 %). The area under the ROC curve (AUC) of 0.944 classified NIBUT as a diagnostic test with very high accuracy.ConclusionThis study showed a high diagnostic accuracy of NIBUT measured by the handheld lipid layer examination instrument. This simple, reliable, objective and available instrument might regularly take place in routine, standard dry eye diagnostic and can be used by almost every eye specialist.     

Peripheral myopization and visual performance with experimental rigid gas permeable and soft contact lens design

PurposeTo evaluate the performance of two experimental contact lenses (CL) designed to induce relative peripheral myopic defocus in myopic eyes.MethodsTen right eyes of 10 subjects were fitted with three different CL: a soft experimental lens (ExpSCL), a rigid gas permeable experimental lens (ExpRGP) and a standard RGP lens made of the same material (StdRGP). Central and peripheral refraction was measured using a Grand Seiko open-field autorefractometer across the central 60° of the horizontal visual field. Ocular aberrations were measured with a Hartman-Shack aberrometer, and monocular contrast sensitivity function (CSF) was measured with a VCTS6500 without and with the three contact lenses.ResultsBoth experimental lenses were able to increase significantly the relative peripheral myopic defocus up to −0.50 D in the nasal field and −1.00 D in the temporal field (p < 0.05). The ExpRGP induced a significantly higher myopic defocus in the temporal field compared to the ExpSCL. ExpSCL induced significantly lower levels of Spherical-like HOA than ExpRGP for the 5 mm pupil size (p < 0.05). Both experimental lenses kept CSF within normal limits without any statistically significant change from baseline (p > 0.05).ConclusionsRGP lens design seems to be more effective to induce a significant myopic change in the relative peripheral refractive error. Both lenses preserve a good visual performance. The worsened optical quality observed in ExpRGP was due to an increased coma-like and spherical-like HOA. However, no impact on the visual quality as measured by CSF was observed.