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IRCT2013062413567N4 IRCT 2013-11-01 Vice chancellor for research, Tehran University of Medical Science Impact of Omega-3 supplement on dry eye treatment Clinical trial comparing the effects of omega-3 supplements and artificial tear drops on dry eye symptoms after surgery, cataract emulsification methods 2013-08-07 anticipated 60 Complete https://irct.ir/trial/13389 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Dry eye syndrome. Intervention 1: Intervention group : The first patient with a unique code (1) be given package A (i.e. oral Omega-3 capsules plus Artelac Eye Drops) . Patients need to instil a drop of artificial Eye Drops , with trademark of Artelac , every 6 hours a day for three months. It contains 1.6 milligram (0.5 millilitre ) of artificial tears mainly hypromellose. In addition participants in the intervention group should take 1000 mg oral Omega-3 capsules three times a day after meal (morning, noon and evening)for three months. One Omega-3 capsule, with trademark of Vita Natural Fish Oil Capsules, contains 180 milligram Eicosapentaenoic Acid and 120 milligram of Docosahexaenoic Acid. Volunteers continue this treatment for three months and return for examination afterwards. Intervention 2: Control group: The second patient with a unique code (2) be given package B (i.e. Artelac Eye Drops). Patients in the control group need to instil a drop of artificial Eye Drops, with trademark of Artelac from Bausch and Lomb Germany, every 6 hours a day for three months . It contains 1.6 milligram (0.5 millilitre) of artificial tears mainly hypromellose. Volunteers continue this treatment for three months and return for examination afterwards.
public Mehrdad Mohammadpour
Eye Research Center,Farabi Hospital,Ghazvin Square,South Kargar Avenue,Enghelab Square,Tehran,Iran.
Tehran Iran (Islamic Republic of) +98 21 5542 1006 MAHAMMADPOUR@yahoo.com Tehran University of Medical Sciences scientific Doctor Mehrdad Mohammadpour
Eye Research Center,Farabi Hospital,Ghazvin Square,South Kargar Avenue,Enghelab Square,Tehran,Iran.
Tehran Iran (Islamic Republic of) +98 21 5542 1006 MAHAMMADPOUR@YAHOO.COM Eye Research Center,Farabi Hospital. Iran (Islamic Republic of) The Inclusion criteria: 1-Dry-eye symptoms following Phacoemulsification Cataract Surgery 2-Index of 30 or more from the Ocular Surface Disease Questionnaire 3-The Schirmer test of 10 millimeter or less 4-The Tear Break up Times of 7 seconds or less 5-Lack of eye trauma 6-The absence of uveitis Exclusion criteria: 1-Surgery on eyes including Surgical Correction of Refractive Errors 2-Using contact lenses 3-Systemic diseases which cause dry eye such as Sjogren ,Diabetic Retinopathy and end organ damage disease no limit no limit Both H04.1 Other disorders of lacrimal gland Treatment - Drugs Placebo Intervention group : The first patient with a unique code (1) be given package A (i.e. oral Omega-3 capsules plus Artelac Eye Drops) . Patients need to instil a drop of artificial Eye Drops , with trademark of Artelac , every 6 hours a day for three months. It contains 1.6 milligram (0.5 millilitre ) of artificial tears mainly hypromellose. In addition participants in the intervention group should take 1000 mg oral Omega-3 capsules three times a day after meal (morning, noon and evening)for three months. One Omega-3 capsule, with trademark of Vita Natural Fish Oil Capsules, contains 180 milligram Eicosapentaenoic Acid and 120 milligram of Docosahexaenoic Acid. Volunteers continue this treatment for three months and return for examination afterwards. Control group: The second patient with a unique code (2) be given package B (i.e. Artelac Eye Drops). Patients in the control group need to instil a drop of artificial Eye Drops, with trademark of Artelac from Bausch and Lomb Germany, every 6 hours a day for three months . It contains 1.6 milligram (0.5 millilitre) of artificial tears mainly hypromellose. Volunteers continue this treatment for three months and return for examination afterwards. Eye problems in performing daily. Timepoint: Before intervention-Three months after treatment. Method of measurement: Ocular Surface Disease Index Questionnaire. Tear break up time. Timepoint: Before intervention-Three months after treatment. Method of measurement: Measured in seconds -With timer and Slit Lamp. Moisture eye. Timepoint: Before intervention-Three months after treatment. Method of measurement: Schirmer Test -Millimeters. Visual acuity. Timepoint: Before intervention-Three months after treatment. Method of measurement: Snelen chart. Vice chancellor for research, Tehran University of Medical Science Approved 2013-07-14 Ethics Committee of Tehran University of Medical Sciences Central Organization of University, Qods Ave.,Keshavarz Blvd.,Vali-e-Asr Square,Tehran,Iran. Tehran Iran (Islamic Republic of)