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

University of Indonesia (UI)

Status: Enrolling

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

Treatments: Drug: Oral Vitamin C; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06781970

24-08-1198

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups, including a placebo group

Vit C

Experimental group

Description:

Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification

Treatment:

Drug: Oral Vitamin C

Preoperative Vit C

Experimental group

Description:

Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification and placebo, tid, 4 weeks after phacoemulsification

Treatment:

Drug: Placebo

Drug: Oral Vitamin C

Placebo

Placebo Comparator group

Description:

Patient will consume placebo, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification

Treatment:

Drug: Placebo