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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Endothelial Cell Loss, Corneal, Cataract and Intraocular Lens (IOL) Surgery

In brief

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

Key facts

Study ID: NCT06781970
Run by: Indonesia University
People needed: 120
Starts: 2024-12-07
Expected to finish: 2025-06-01
Last updated by the study team: 2025-01-17

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Males and females aged 60 years or older
Patients with immature senile cataracts in one or both eyes, with LOC (lens opacities classification) III nuclear opacity grade 4-6 and nuclear color grade 4-6 criteria
Patients willing to undergo phacoemulsification cataract surgery and consume the study medication as allocated, as well as participate in follow-up assessments for 7 weeks
Patients with no history of previous intraocular surgery
Patients with no history of allergy to vitamin C
Patients not routinely consuming other vitamins
Patients who agree to and sign the informed consent for the study

Where it is running

RSUD Sayang — Cianjur, West Java, Indonesia (enrolling)
Pharmacology Laboratory of the University of Indonesia — Jakarta, DKI Jakarta, Indonesia

Full record on ClinicalTrials.gov

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