Rahul Bhargava1, Prachi Kumar, Yogesh Arora. 1. Laser Eye Clinic (R.B.), Noida, India; Department of Ophthalmology (R.B., Y.A.), School of Medical Sciences and Research, Sharda University, Greater Noida, India; and Department of Pathology (P.K.), School of Medical Sciences and Research, Sharda University, Greater Noida, India.
Abstract
OBJECTIVE: To evaluate the effect of an omega 3 fatty acid (O3FA) oral supplement (2,400 mg/day) for 45 days on dry eye symptoms, tear production, stability, and conjunctival cytology in young and middle-aged visual display terminal (VDT) users. METHODS: Institutional review board approval was obtained, and a randomized, double-blind, interventional study was done; eyes of 256 VDT users were randomized to receive 4 capsules twice daily for 45 days (O3FA group), each containing 180 mg of eicosapentaenoic acid and 120 mg docosahexaenoic acid. The O3FA group was compared with another group (n=266) who received 8 capsules of a placebo (olive oil). Patients were evaluated at baseline, 30 days, and 45 days. The primary outcome measure was an improvement in dry eye symptoms. Secondary outcome measures were improvement in the Nelson grade on conjunctival impression cytology, Schirmer test values, and tear film breakup time (TBUT). Means of groups (pretreatment, day 30, and day 45) were compared with repeated-measure analysis of variance. The relation between the outcome variables and VDT time was evaluated using linear regression. RESULTS: In the O3FA group, the mean symptom score differed significantly (P<0.005) (pretreatment, 30 days, and 45 days); the TBUT and Nelson grade also improved significantly but only after 45 days of intervention. Schirmer test values did not differ significantly after adjustment for multiple comparisons (P=0.010). The change was not significant in the placebo group. CONCLUSION: Consumption of 2,400 mg/day of O3FA supplement improves symptoms, tear stability, and conjunctival cytology but not tear production in symptomatic VDT users.
RCT Entities:
OBJECTIVE: To evaluate the effect of an omega 3 fatty acid (O3FA) oral supplement (2,400 mg/day) for 45 days on dry eye symptoms, tear production, stability, and conjunctival cytology in young and middle-aged visual display terminal (VDT) users. METHODS: Institutional review board approval was obtained, and a randomized, double-blind, interventional study was done; eyes of 256 VDT users were randomized to receive 4 capsules twice daily for 45 days (O3FA group), each containing 180 mg of eicosapentaenoic acid and 120 mg docosahexaenoic acid. The O3FA group was compared with another group (n=266) who received 8 capsules of a placebo (olive oil). Patients were evaluated at baseline, 30 days, and 45 days. The primary outcome measure was an improvement in dry eye symptoms. Secondary outcome measures were improvement in the Nelson grade on conjunctival impression cytology, Schirmer test values, and tear film breakup time (TBUT). Means of groups (pretreatment, day 30, and day 45) were compared with repeated-measure analysis of variance. The relation between the outcome variables and VDT time was evaluated using linear regression. RESULTS: In the O3FA group, the mean symptom score differed significantly (P<0.005) (pretreatment, 30 days, and 45 days); the TBUT and Nelson grade also improved significantly but only after 45 days of intervention. Schirmer test values did not differ significantly after adjustment for multiple comparisons (P=0.010). The change was not significant in the placebo group. CONCLUSION: Consumption of 2,400 mg/day of O3FA supplement improves symptoms, tear stability, and conjunctival cytology but not tear production in symptomatic VDT users.
Authors: Penny A Asbell; Maureen G Maguire; Ellen Peskin; Vatinee Y Bunya; Eric J Kuklinski Journal: Contemp Clin Trials Date: 2018-06-06 Impact factor: 2.226