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

Inclusion Criteria7

  • 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

Exclusion Criteria1

  • \-

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

View Full Details on ClinicalTrials.gov

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NCT06781970