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

ConditionsEndothelial Cell Loss, CornealCataract and Intraocular Lens (IOL) Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorIndonesia University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral Vitamin C

    Drug

    Patients will be given 500 mg of oral vitamin C, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification

  • Placebo

    Drug

    Patients will be given placebo, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Vit CExperimental treatment 1 intervention
Group B: Preoperative Vit CExperimental treatment 2 interventions
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Endothelial cell loss

Difference of endothelial cell density before and after phacoemulsification

Time frame
From the start of the study to six weeks after intervention

Secondary outcomes

1

Serum ascorbic acid levels

Level of ascorbic acid in serum

Time frame
From the start of the study to seven days after intervention
2

Serum total antioxidant capacity levels

Level of total antioxidant capacity in serum

Time frame
From the start of the study to seven days after intervention
3

Serum malondialdehyde levels

Levels of malondialdehyde in serum

Time frame
From the start of the study to seven days after intervention
4

Aqueous ascorbic acid levels

Level of aqueous ascorbic acid

Time frame
Right before phacoemulsification

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indonesia University

Lead sponsor

Source ClinicalTrials.gov
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