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

Last updated: January 13, 2025
Sponsor: Indonesia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Vision Loss

Eye Disease

Treatment

Placebo

Oral Vitamin C

Clinical Study ID

NCT06781970
24-08-1198
  • Ages > 60
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Males and females aged 60 years or older

  • Patients with immature senile cataracts in one or both eyes, with LOC (lensopacities classification) III nuclear opacity grade 4-6 and nuclear color grade 4-6criteria

  • Patients willing to undergo phacoemulsification cataract surgery and consume thestudy medication as allocated, as well as participate in follow-up assessments for 7weeks

  • 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

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
December 07, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Pharmacology Laboratory of the University of Indonesia

    Jakarta, DKI Jakarta 10430
    Indonesia

    Site Not Available

  • RSUD Sayang

    Cianjur, West Java 43216
    Indonesia

    Active - Recruiting

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