IRCT2013062413567N4.

Trial name or title	Public title: impact of omega‐3 supplement on dry eye treatment Scientific title: clinical trial comparing the effects of omega‐3 supplements and artificial tear drops on dry eye symptoms after surgery, cataract emulsification methods
Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): single‐center Number randomized (total and per group): 60 eyes (planned) Unit of randomization (individual or eye): not reported Exclusions after randomization: not reported Losses to follow‐up: not reported Number analyzed (total and per group): not reported Unit of analysis (individual or eye): not reported Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N
Participants	Baseline characteristics Country: Iran Age (mean ± SD, range): not reported Gender: not reported Inclusion criteria: 1. Dry eye symptoms following phacoemulsification cataract surgery 2. Index of 30 or more from the Ocular Surface Disease Questionnaire 3. Schirmer test of 10 millimeters or less 4. TBUTof 7 seconds or less 5. Lack of eye trauma 6. Absence of uveitis Exclusion criteria: 1. Historic eye surgeries 2. Using contact lenses 3. Suffering from systemic diseases such as Sjögren's syndrome and diabetic retinopathy that causes dry eye Equivalence of baseline characteristics? (Y/N): not reported
Interventions	Intervention #1: omega‐3 capsules (Vita Natural Fish Oil Capsules) containing eicosapentaenoic acid 180 mg and docosahexaenoic acid 120 mg, 3 times daily Intervention #2 (control): no oral capsule Length of follow‐up: 3 months Notes: participants in both groups were instructed to instil a drop of artificial tears every 6 hours
Outcomes	Primary outcome(s): OSDI; visual acuity; Schirmer test; TBUT Secondary outcome(s): none Adverse events reported? (Y/N): not reported Measurement time points (specify intervals at which outcomes were assessed): not reported Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Starting date	First enrollment: August 7, 2013
Contact information	Dr. Mehrdad Mohammadpour Eye Research Center Farabi Hospital Ghazvin Square South Kargar Avenue, Enghelab Square, Tehran, Iran.
Notes	Notes: reported to be "not blinded" Recruitment status: reported to be "complete" on February 22, 2018 (last update) Other notes: study sponsored by Vice Chancellor for research, Tehran University of Medical Science