RecruitingNot ApplicableNCT06781970

Effect of Vitamin C Supplementation in Corneal Endothelial Damage in Phacoemulsification of Patients with Hard Cataracts

The Effects of Vitamin C Supplementation on Corneal Endothelial Damage in Hard Cataract Phacoemulsification: an Oxidative Stress Study on Aqueous Humour and Corneal Endothelial Cell Characteristics.


Sponsor

Indonesia University

Enrollment

120 participants

Start Date

Dec 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to analyze the protective effects of oral ascorbic acid on the corneal endothelial layer undergoing oxidative stress due to phacoemulsification in patients with hard cataracts. The main questions it aims to answer are: 1. Will oral vitamin C administration provide better protection to the corneal endothelium in hard cataract phacoemulsification by comparing preoperative and postoperative administration, preoperative only, and no administration? 2. How does oxidative stress (MDA levels) in the aqueous humour increase after oral vitamin C administration compared to no administration? 3. Will there any changes in MDA levels in the aqueous humour and blood after oral vitamin C administration compared to no administration? 4. Does MDA levels in the aqueous humour correlate with MDA levels in the blood? Researchers will compare vitamin C to a placebo to see if vitamin C as an antioxidant works in preventing corneal endothelial damage due to phacoemulsification. Participants will: * Take 500 mg of oral vitamin C or placebo three times a day for seven days prior to phacoemulsification * Undergo phacoemulsification * Take vitamin C or placebo three times a day for 28 days after phacoemulsification * Visit the ophthalmology clinic 1, 7, 28, and 42 days post-operative for checkups * Keep a logbook to record the drug they take and to write symptoms of possible side effect of the drug


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether Vitamin C supplements taken before and after cataract surgery help protect the cells on the inner surface of the cornea (the clear front of the eye) from damage caused by the surgery itself. Cataract surgery can sometimes injure these cells, which are important for clear vision. **You may be eligible if...** - You are 60 years or older - You have an immature (not too advanced) age-related cataract requiring surgery - You are willing to take the study medication and attend follow-up appointments for 7 weeks - You have not had previous eye surgery - You are not allergic to Vitamin C and do not regularly take other vitamins **You may NOT be eligible if...** - There are no listed exclusion criteria beyond those above Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral Vitamin C

Patients will be given 500 mg of oral vitamin C, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification

DRUGPlacebo

Patients will be given placebo, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification


Locations(2)

Pharmacology Laboratory of the University of Indonesia

Jakarta, DKI Jakarta, Indonesia

RSUD Sayang

Cianjur, West Java, Indonesia

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NCT06781970


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