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

Not Applicable

Recruiting

• Conditions: Endothelial Cell Loss, Corneal; Cataract and Intraocular Lens (IOL) Surgery
• Interventions: Drug: Oral Vitamin C; Drug: Placebo

• Registration Number: NCT06781970
• Lead Sponsor: Indonesia University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-07
• Study First Submitted: 2024-12-17
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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 Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vit C	Oral Vitamin C	Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification
Preoperative Vit C	Oral Vitamin C	Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification and placebo, tid, 4 weeks after phacoemulsification
Preoperative Vit C	Placebo	Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification and placebo, tid, 4 weeks after phacoemulsification
Placebo	Placebo	Patient will consume placebo, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification

Primary Outcome Measures

Name	Time	Method
Endothelial cell loss	From the start of the study to six weeks after intervention	Difference of endothelial cell density before and after phacoemulsification

Secondary Outcome Measures

Name	Time	Method
Serum ascorbic acid levels	From the start of the study to seven days after intervention	Level of ascorbic acid in serum
Serum total antioxidant capacity levels	From the start of the study to seven days after intervention	Level of total antioxidant capacity in serum
Serum malondialdehyde levels	From the start of the study to seven days after intervention	Levels of malondialdehyde in serum
Aqueous ascorbic acid levels	Right before phacoemulsification	Level of aqueous ascorbic acid
Aqueous total antioxidant capacity levels	Right before phacoemulsification	Levels of total antioxidant capacity in aqueous humour
Aqueous malondialdehyde levels	Right before phacoemulsification to 3 minutes after phacoemulsification	Levels of malondialdehyde in aqueous humour
Central corneal thickness	rom the start of the study to six weeks after intervention	Thickness of the central part of the cornea
Grading of cells in anterior chamber	From the start of the study to six weeks after intervention	Collection of white blood cells in the anterior chamber
Visual acuity of patients	From the start of the study to six weeks after intervention	A measure of the ability of the eye to distinguish shapes and the details of objects at a given distance

Trial Locations

Locations (2)

Pharmacology Laboratory of the University of Indonesia; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

RSUD Sayang; 🇮🇩 Cianjur, West Java, Indonesia