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.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Indonesia
RSUD Sayang
RECRUITING
Cianjur
Pharmacology Laboratory of the University of Indonesia
NOT_YET_RECRUITING
Jakarta
Contact Information
Primary
Syska Widyawati, Master of Medical Education
syska.widyawati@gmail.com
+62 818473841
Backup
Rafida Kamila, Medical Doctor
rafida.sofi1997@gmail.com
+62 81217169169
Time Frame
Start Date: 2024-12-07
Estimated Completion Date: 2025-06
Participants
Target number of participants: 120
Treatments
Experimental: Vit C
Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification
Experimental: Preoperative Vit C
Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification and placebo, tid, 4 weeks after phacoemulsification
Placebo_comparator: Placebo
Patient will consume placebo, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification
Related Therapeutic Areas
Sponsors
Leads: Indonesia University

This content was sourced from clinicaltrials.gov