Baseline Ocular Surface Disease Index Research Articles

Re-Esterified Triglyceride ω-3 Fatty Acids in Dry Eye Disease With Meibomian Gland Dysfunction

Taking ω-3 supplements has been associated with a reduction in symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD). However, a recent relatively large clinical trial concluded that treating DED with ω-3 consumption was ineffective, potentially warranting additional investigations. To investigate the effect of re-esterified triglyceride (rTG) ω-3 fatty acid supplementation on DED associated with MGD. This double-masked, parallel-group, randomized clinical trial was conducted at 7 institutions from September 2020 to January 2023. Patients with DED associated with MGD were included and randomly assigned to the ω-3 group (received 1680 mg of eicosapentaenoic acid and 560 mg of docosahexaenoic acid), whereas those in the grape-seed group received 3000 mg of grape-seed oil daily. rTG ω-3 Fatty acid supplementation vs grape-seed oil. The primary end point was the Ocular Surface Disease Index (OSDI) from baseline to 6 and 12 weeks. The safety parameters were visual acuity and intraocular pressure change. A total of 132 patients (mean [SD] age, 50.6 [13.8] years; 103 female [78.0%]) were included in this study. The mean (SD) baseline OSDI scores of the ω-3 and grape-seed groups were 43.5 (16.5) and 44.1 (16.6), respectively. A total of 58 patients (87.9%) and 57 patients (86.4%) in the ω-3 and grape-seed groups, respectively, completed 12 weeks of follow-up. There were no differences in compliance with the dietary supplement intake between groups (ω-3, 95.8% and grape-seed, 95.4%). The OSDI (SD) change from baseline to 6 and 12 weeks was -20.5 (16.0) and -22.7 (15.7), respectively, in the ω-3 group and -15.1 (20.2) and -18.8 (21.7), respectively, in the grape-seed control group (difference at 6 weeks = -5.4; 95% CI, -12.15 to 1.33; P = .12 and at 12 weeks = -3.9; 95% CI, -10.90 to 3.13; P = .28). There were no changes in safety parameters or adverse events related to taking the dietary supplement in either group. This randomized clinical trial did not show a benefit of the rTG form of ω-3 for ameliorating symptoms of DED associated with MGD, although fewer than 60 participants were evaluated in each group. Any secondary outcomes from this study should be considered for hypothesis generation of future evaluations of the effect of the rTG form of ω-3 on DED associated with MGD. CRIS Identifier: KCT0004927.

Assessment of the efficacy of 0.1% cyclosporine A cationic emulsion in the treatment of dry eye disease during COVID-19 pandemic.

Objective: To assess the efficacy of 0.1% cyclosporine A (CsA) cationic emulsion (CE) in the treatment of dry eye disease (DED) in terms of ocular surface disease index (OSDI). Methods: DED patients with corneal fluorescein staining grade (CFS) ≤ 3 on the Oxford scale and Schirmer test score < 10 mm/ 5 min were enrolled for once-daily CsA use in this observational, prospective, one-center study. Efficacy of CE at 30, 60, and 90-day follow-up visit was evaluated using OSDI questionnaire. Both the overall OSDI score and the outcomes for all subscales - ocular symptoms (OS), vision-related function (VRF) and environmental triggers (ET) were considered. Results: Twelve patients (10 women and 2 men), whose baseline OSDI ranged between 27.08 and 70.03 mm (48.2 ± 11.8), were included. Their achieved mean scores for subscales such OS, VRF and ET were 66.6 ± 16.8, 42.2 ± 12.0 and 42.2 ± 12.5, respectively. Statistically significant results were obtained after 30 days for OSDI (45.5 ± 10.0; p=0.011), whereas after 90 days for both OSDI (35.4 ± 7.4; p=0.003) and OS (47.2 ± 10.9; p=0.005), VRF (30.5 ± 6.1; p=0.003) and ET (33.3 ± 11.2; p=0.008). Conclusions: CsA CE significantly reduced symptoms of patients with DED. Recovery was the most successful after 90 days of treatment and included OSDI, OS, VRF and ET. Abbreviations: CE = cationic emulsion, CFS = corneal fluorescein staining, CsA = cyclosporine A, DED = dry eye disease, ET = environmental triggers, OS = ocular symptoms, OSDI = ocular surface disease index, VRF = vision-related function.

Pterygium surgery with lyophilized versus cryopreserved amniotic membrane graft

To evaluate surgical outcomes (recurrence rate, aesthetics and symptoms) of pterygium surgery with two different amniotic membrane preservation approaches - lyophilized (LAM) and cryopreserved (CAM). Primary pterygium patients were randomized to either LAM or CAM surgery. Demographic data, ocular surface disease index (OSDI), aesthetic grading (1 to 4), recurrences and complications were recorded over a 6-month follow-up period. Twenty-nine patients were recruited. Recurrence at month 6 was detected in 11 cases (37.9%) and was more prevalent with CAM grafts, without reaching statistical significance (P=0.196). Aesthetic outcome grading showed no differences between LAM and CAM at month 6 (P=0.124). Aesthetic results were mostly unsatisfactory (grade 3 and 4) without statistical differences between groups (P=0.514). Baseline OSDI was similar in both groups (P=0.888), and it significantly decreased by the last follow-up visit (P<0.001) for both the LAM and CAM groups. This decrease did not significantly differ between amniotic membrane preservation approach surgery groups (P=0.714). LAM might be considered a legitimate alternative to CAM, showing no inferiority in outcomes, since clinical and aesthetic outcomes were similar for both groups.

OSDI Outcomes Based on Patient Demographic and Wear Patterns in Prosthetic Replacement of the Ocular Surface Ecosystem.

PurposeTo evaluate the impact of prosthetic replacement of the ocular surface ecosystem (BostonSight PROSE) treatment on symptom outcomes based on the Ocular Surface Disease Index (OSDI).Patients and MethodsThis was a single-center, retrospective analysis of consecutive patients who initiated PROSE treatment between September 2017 and December 2019 by the same clinician. The primary outcome measure was to compare OSDI survey scores at baseline prior to PROSE treatment and at follow-up, after PROSE treatment. Indication for treatment, sex, age, device diameter, average wear time, preexisting mental illness, duration of PROSE wear, and status of PROSE wear at follow-up were also studied.ResultsA total of 134 patients underwent PROSE treatment and completed a baseline OSDI survey during the study period. Forty-three patients completed a follow-up OSDI survey and were included in the study analysis. The most common treatment indications were keratoconjunctivitis sicca (n=27) and corneal ectasia (n=16). Baseline average OSDI score was 56.9±23.7 for the 43 subjects who completed a subsequent OSDI survey. The last documented average follow-up OSDI for those 43 subjects was 23.8±15.6, median (IQR) of 22.9 (10.4 to 32.3), and a statistically significant 54.7±27.6% average improvement from baseline (p<0.01). All patients, except for two, showed improvement in OSDI score. Statistically significant improvement occurred regardless of underlying diagnosis with no statistically significant difference based on age, sex, mental illness, or device diameter and no statistical correlation with average wear time, or duration of PROSE wear.ConclusionPROSE treatment improves visual function and symptom relief as demonstrated by the OSDI survey. Sex, age, preexisting mental illness, device diameter, average wear time, and duration of wear had no statistically significant impact on OSDI outcomes.

Factors influencing the clinical outcomes of intense pulsed light for meibomian gland dysfunction.

To observe the clinical outcomes of intense pulsed light (IPL) for meibomian gland dysfunction (MGD) and identify its influencing factors.Forty-eight eyes of 48 patients with MGD were included. Subjects were followed up 5 times on day 1, day 15, day 30, day 45, and day 120, and underwent 3 sessions of the IPL treatment on day 1, day 15 and day 30. Gender, age, duration of MGD, time of video display terminal usage, and severity of MGD were recorded at baseline. At every visit, Ocular Surface Disease Index (OSDI), eyelid margin abnormality score, tear film breakup time, Schirmer I test (S ɪ t) and corneal fluorescein staining were recorded. The clinical parameters before and after 3 IPL treatments were compared. Univariate and multivariable logistic regression analyses were performed to explore influencing factors.Compared with baseline, the tear film breakup time was increased and the corneal fluorescein staining score and OSDI were significantly decreased on day 45 and day 120 (all P < .001). In univariate analysis, among the patients with a younger age (18–39 years), moderate MGD, higher baseline S ɪ t and higher baseline OSDI, the IPL treatment had a higher effective rate (P = .032, .004, .024, and .014 respectively). The MGD severity was strongly associated with effective IPL, and patients with moderate MGD had an OR of 22.454 compared with the severe MGD patients (OR = 22.454, 95% CI: 2.890-174.436, P = .003).IPL effectively improves clinical symptoms and some signs in MGD patients. Age, MGD severity, baseline S ɪ t and baseline OSDI are potential factors that may influence the clinical outcomes of IPL. MGD severity is an independent influencing factor.

Effect of a Novel Omega-3 and Omega-6 Fatty Acid Supplement on Dry Eye Disease: A 3-month Randomized Controlled Trial.

Supplementing diet with a novel combination of omega-3 and omega-6 fatty acids significantly improved symptoms in extremely symptomatic participants with dry eye disease (DED). This study aimed to determine the effect of daily intake of a novel combination of essential fatty acids on signs and symptoms of DED. Participants with moderate to severe DED were enrolled in a prospective, randomized, double-masked parallel group study. Participants ingested either the treatment supplement containing omega-3 and omega-6 fatty acids (1200 mg eicosapentaenoic acid, 300 mg docosahexaenoic acid, 150 mg γ-linoleic acid) or the placebo (coconut and olive oil) daily for 3 months. To determine compliance, Omega-3 Index blood tests were conducted. At baseline and at 1 and 3 months, the following assessments were conducted: Ocular Surface Disease Index (OSDI) questionnaire and Symptom Assessment Questionnaire in Dry Eye, noninvasive tear breakup time, tear meniscus height, tear osmolarity, ocular redness, surface staining, Schirmer test, and meibography. Fifty participants (mean ± standard deviation baseline OSDI score, 52.2 ± 16.5) completed the study: 24 randomized to treatment and 26 randomized to placebo. Although there was an improvement in OSDI score at 3 months for both groups (treatment: -13.4 points, P = .003; placebo: -7.8 points, P = .02), participants with baseline OSDI scores >52 demonstrated an even larger significant improvement in symptoms with the treatment at 3 months compared with baseline (n = 13, -20.8 points, P = .002). There were no significant changes in any of the ocular assessments at 1 or 3 months (all P > .05). After 3 months, Omega-3 Index increased by 34% in the treatment group (baseline, 5.3 ± 0.8; 3 months, 8.0 ± 2.1; P < .001) and did not change in the placebo group (baseline, 4.8 ± 0.8; 3 months, 4.8 ± 0.6; P = .95). Supplementation with eicosapentaenoic acid, docosahexaenoic acid, and γ-linoleic acid resulted in a significant and clinically meaningful improvement of dry eye symptoms in extremely symptomatic participants with DED (OSDI ≥52).

The effect of tamarind seed polysaccharidecontaining eye drop in dry eye syndrome: Results of an interventional, comparative, clinical study

Background: The mainstay of dry eye treatment is artificial tear solutions. Contralateral eye comparison of 2 types of artificial tears (Xiloial versus Tearlose) in managing dry eye disease was sought in this study.&#x0D; Methods: This study was a prospective, interventional, contralateral eye comparison of 2 types of artificial tears used for managing dry eye disease. The study participants were categorized into mild (13–22 points), moderate (23–32 points), or severe (33–100 points) ocular surface disease according to the baseline ocular surface disease index (OSDI) questionnaire score. Schirmer I and tear film break-up time (TBUT) tests, as well as detailed slit-lamp examinations, were performed at baseline and at the end of the study. All participants received Xiloial monodose eye drops for the right eye and Tearlose eye drops for the left eye, administered as a single drop 4 times per day. Furthermore, they were instructed to perform lid hygiene every 12 hours per day for both eyes.&#x0D; Results: Thirty-five patients (70 eyes) with a mean ± standard (SD) age of 50.2 ± 13.4 years were included, and 14 (40%) were men. The mean ± SD of the OSDI score was 44.24 ± 22.59 at baseline. Of the 35 patients, 10 (28.6%), 5 (14.3%), and 20 (57.1%) had mild, moderate, and severe ocular surface disease, respectively, according to the baseline OSDI score. Compared to baseline, the mean values of both TBUT and Schirmer I tests improved significantly in both groups (both P &lt; 0.001). In comparing the final mean values between the 2 groups, this improvement was comparable for the Schirmer I test (P = 0.179), but TBUT in Tearlose-instilled eyes improved significantly more than in the fellow eyes (P &lt; 0.001).&#x0D; Conclusions: Both Xiloial and Tearlose eye drops improved tear stability and tear production after a 2 week treatment period in eyes with dry eye disease. This improvement was comparable for tear production, but Tearlose-instilled eyes showed significantly greater improvement in tear stability. Further studies with longer follow-up and larger sample sizes could provide more reliable results as a basis for the clinical use of this TSP-containing lubricant eye drop solution in dry eye disease.

Correlation of Measures From the OCULUS Keratograph and Clinical Assessments of Dry Eye Disease in the Dry Eye Assessment and Management Study.

The purpose of this study was to compare objective, noninvasive assessments of tear function using the OCULUS Keratograph with the corresponding clinical assessments [tear break-up time (TBUT), Schirmer test, and bulbar erythema] among patients with moderate-to-severe dry eye disease. Participants in the Dry Eye Assessment and Management study at centers having an OCULUS Keratograph were assessed using standardized procedures. Associations between the assessments from the Keratograph [noninvasive keratograph break-up time (NIKBUT), tear meniscus height (TMH), and bulbar redness (BR)] and clinical examination (TBUT, Schirmer test, and bulbar erythema) and between these test results and Ocular Surface Disease Index (OSDI) scores were summarized with Spearman correlation coefficients (r s ); 95% confidence intervals (95% CI) accounted for intereye correlation. Among 288 patients (576 eyes), the mean (standard deviation) age was 56.6 (13.8) years, 78.1% were female, and the mean baseline OSDI score was 44.3 (14.0). The mean was 2.9 (1.5) seconds for TBUT and 8.2 (5.7) seconds for NIKBUT (their correlation r s = 0.18, 95% CI = 0.09-0.28). The mean was 10.6 (7.6) mm for the Schirmer test and 0.3 (0.2) mm for TMH (r s = 0.15, 95% CI = 0.04-0.25). The median clinical grade redness was mild, and the mean BR score was 1.1 (0.5) (r s = 0.25, 95% CI = 0.15-0.35). Correlation between results of each of the 6 tests and OSDI scores was low (r s from -0.07 to 0.05). In the Dry Eye Assessment and Management study, NIKBUT, TMH, and BR were weakly correlated with their clinical counterparts. No measurements were correlated with the OSDI score.

Carboxymethyl Cellulose versus Hydroxypropyl Methylcellulose Tear Substitutes for Dry Eye Due to Computer Vision Syndrome: Comparison of Efficacy and Safety.

Background:Prolonged use of visual display terminal images on electronic devices such as computers frequently leads to symptoms of dry eye. Tear substitutes form the mainstay of treatment for mild-to-moderate dry eye.Aim:The study aimed to evaluate the efficacy and safety of carboxymethyl cellulose (CMC) versus hydroxypropyl methylcellulose (HPMC) tear substitutes for dry eye due to computer vision syndrome (CVS).Materials and Methods:This was a prospective, randomized, comparative, and open-labeled study. The efficacy of CMC 0.5% and HPMC 0.3% tear substitutes was compared in 180 participants (90 in each group) with dry eye. Change in Ocular Surface Disease Index (OSDI) score, Schirmer I test score, and tear film break up time (TF-BUT) were used as efficacy parameters. Safety was monitored on all visits.Results:The baseline OSDI score? 23.48 and 23.32 in Group A and B, respectively, decreased with treatment in both groups on all follow-up visits as compared to the baseline (day 90: 13.9 ± 3 vs. 14.81 ± 3.17, P: 0.01). The scores of Schirmer I test increased in both groups, with a greater improvement in Group A (at day 90: 22.75 ± 3.04 mm vs. 21.78 ± 3.36 mm, P: 0.04). The values of TF-BUT improved in both groups, the difference being statistically insignificant. An initial stinging was reported by one participant, each in both groups.Conclusion:CMC and HPMC tear substitutes were equally efficacious and safe in reducing symptoms of dry eye due to CVS.

Short-Term Results of Trial of Topical Insulin for Treatment of Dry Eyes in Diabetics.

To assess the short-term effects of topical insulin (TI) 1 unit/drop 4 times per day for 4 weeks on the symptoms and signs of diabetic with dry eye disease (DED). In this randomized, double-blind interventional study, diabetics with DED aged 18 to 60 years were randomly assigned to TI or standard artificial tears (SAT). Baseline Ocular Surface Disease Index (OSDI), Schirmer I test (ST), tear break-up time (TBUT), and ocular Sjögren's International Collaborative Clinical Alliance (SICCA) score were compared 4 weeks after treatment. A total of 160 participants (involving 320 eyes) received either TI (n=80) or SAT (n=80). After 4 weeks of treatment, a significant number of participants in both TI and SAT groups showed improvement in their OSDI score, 66% and 63%, respectively (P=0.0001), but were not significantly better than each other (P=0.453). However, most participants in both groups showed worsening of ST and TBUT (P>0.05). Most of the participants in both groups showed no change in their ocular SICCA score (P>0.05). The study has shown a significant and similar improvement in the OSDI score for TI 1 unit/drop four times daily and SAT in treating diabetics with DED. Further research is required to understand the long-term effects of TI on the ocular surface.

Effects of Prolonged Reading on Dry Eye

To demonstrate the effects of prolonged silent reading on tear film and ocular surface parameters. Prospective, observational clinical study. A total of 177 patients with dry eye and 34 normal controls aged 50 years and older. After evaluating symptoms using the Ocular Surface Disease Index (OSDI) questionnaire, the following tests were performed in consecutive order: automated noninvasive tear break-up time (TBUT), surface asymmetry and regularity indices, Schirmer's testing without anesthesia, corneal staining using fluorescein, and conjunctival staining using lissamine green. The participants were then asked to read a 30-minute validated passage silently. The tests were repeated after the reading task. Changes in tear film and ocular surface parameters after reading. All parameters, with the exception of surface asymmetry index, worsened after the reading task in patients with dry eye and in controls. The worsening reached a statistical significance for corneal and conjunctival staining in the dry eye group (P < 0.001) and for corneal staining in the control group (P < 0.01). At baseline, OSDI scores correlated only with corneal and conjunctival staining scores (r= 0.19, P= 0.006 and r= 0.27, P < 0.001). Among postreading measurements, baseline OSDI scores correlated with TBUT (r=-0.15, P= 0.03) in addition to corneal and conjunctival staining (r= 0.25, P < 0.001 and r= 0.22, P= 0.001). Changes in TBUT and Schirmer's test correlated significantly with their respective baseline values (r=-0.61, P < 0.001 and r=-0.44, P < 0.001), indicating that the more unstable the tear film and the lower the aqueous tear secretion, the worse they became after the prolonged reading task. Worsening in corneal staining directly correlated with the baseline conjunctival staining (r= 0.17, P= 0.02) and surface regularity index (r= 0.21, P= 0.01). Evaluating tear film and ocular surface parameters at rest may miss clinical findings brought about by common everyday tasks such as reading, leading to discordance between patient-reported symptoms and clinician-observed signs. Quantifying dry eye after visually straining activities such as prolonged silent reading may help better understand patient symptomatology.

SIDRE: Symptomatic Improvement of Dry Eye Study.

PurposeThe aim of this study was to evaluate the effectiveness of lifitegrast 5% ophthalmic solution in reducing the symptoms of eye dryness using Ocular Surface Disease Index (OSDI) questionnaire.MethodsA single-center study was undertaken to evaluate the clinical outcomes. Fourteen subjects (12 female and 2 male) with symptoms of dry eye and a positive history of recent use of artificial tears were included in the study. OSDI questionnaire scores on the severity of symptoms, visual functionality, and quality of life related to the condition were recorded pre- and post-therapy. Subsequently, score data were analyzed for statistical significance.ResultsThe mean age of the 14 subjects was 44.86 (standard deviation [SD] ±3.08) years, with a range of 23–62 years. Mean duration of the evaluation was 28.79 days with a range of 25–34 days. Baseline OSDI mean score was 49.40 (SD ±1.28), and post-therapy mean score was 42.26 (SD ±0.99). Data analysis revealed that the scores were statistically significantly improved post-lifitegrast therapy in comparison to baseline (p=0.00041).ConclusionLifitegrast 5% ophthalmic solution may be a beneficial therapeutic option in the management of symptoms associated with dry eye disease.

Increased corneal sub-basal nerve density in patients with Sjögren syndrome treated with topical cyclosporine A.

To evaluate quantitative and qualitative changes in sub-basal corneal nerves (SBN) via in vivo confocal microscopy in patients with Sjögren syndrome dry eye (SSDE) treated with topical cyclosporine A (CsA). Prospective, observational, non-randomized study. Thirty eyes of 30 patients with SSDE refractory to conventional treatment treated with CsA 0.05% twice daily for 6months. Fifteen eyes of 15 healthy, age and gender matched, volunteers constituted the control group at baseline. A clinical evaluation of dry eye, corneal sensation using Cochet-Bonnet esthesiometry and in vivo confocal microscopy analysis of the central cornea were performed prospectively at baseline for all patients, and after 6months of treatment with CsA. Density, number, reflectivity and tortuosity of SBN, dendritic cell (DC) density, esthesiometry, and dry eye signs and symptoms. Topical CsA 0.05% improved clinical signs and symptoms, and increased corneal sensitivity. Following treatment, SBN density was significantly increased (P<0.0001) associated with a decreased in DC density (P<0.0001). The increase in SBN density after treatment was positively correlated with baseline SBN density (R2 =0.33; P=0.0008) and negatively correlated with baseline Ocular Surface Disease Index (R2 =0.28; P=0.002), Oxford score (R2 =0.31; P=0.002), and DC density (R2 =0.37; P=0.0003). Topical CsA led to an increase in corneal SBN density, improving clinical signs and symptoms of SSDE. Our results also suggest an improved response to treatment in patients with less initial nerve damage.

Efficacy and safety of chondroitin sulfate/xanthan gum versus polyethylene glycol/propylene glycol/hydroxypropyl guar in patients with dry eye

Purpose:To evaluate the efficacy and safety of two ophthalmic solutions in patients with mild to moderate dry eye.Methods:We performed a prospective, 2-month-long, randomized, double-blind, single-center, parallel clinical trial to compare the efficacy and safety of two ophthalmic solutions for dry eye treatment. Patients were randomly assigned to one of the two treatment groups, study group or active-control group, and received one drop four times a day. The primary efficacy endpoint was to extend the tear film break-up time (TBUT) after 2 months of treatment. The Ocular Surface Disease Index (OSDI) was also evaluated. Safety measures were assessed by the presence of adverse events.Results:A total of 28 patients with mild to moderate dry eye were included in the per protocol analysis. TBUT was similar between groups at baseline (chondroitin sulfate and xanthan gum [CS/XG] group, 5.2 ± 2.3; Systane® group, 4.7 ± 2.6; P = 0.488), after 2 months of treatment, TBUT was still similar in both groups (CS/XG group, 6.1 ± 2.5; Systane® group, 7.3 ± 2.5; P = 0.088). Baseline OSDI was similar between the groups (CS/XG group, 18.8 ± 5.3; Systane® group, 19.8 ± 7.1; P = 0.810), but after 2 months of treatment, the OSDI was significantly lower in the CS/XG group (6.7 ± 5.7 versus 10.8 ± 6.4; P = 0.049). An adverse event was present in the CS/XG group, but it was not related to the treatment.Conclusions:In this population of patients with mild to moderate dry eye, treatment with CS/XG was as effective as treatment with Systane® with regard to TBUT; nevertheless, treatment in the CS/XG group was more effective at diminishing OSDI.