Clinical trial NCT06781970: Effect of Vitamin C Supplementation in Corneal Endothelial Damage in Phacoemulsification of Patients with Hard Cataracts
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endothelial Cell Loss, Corneal
Cataract and Intraocular Lens (IOL) Surgery
Keywords: Cataract
Corneal Endothelial Damage
Phacoemulsification
Total Antioxidant Capacity
Ascorbic Acid
Vitamin C Supplementation
malondialdehyde
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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:

-

Primary outcomes:
measure: Endothelial cell loss
timeFrame: From the start of the study to six weeks after intervention
Secondary outcomes:
measure: Serum ascorbic acid levels
timeFrame: From the start of the study to seven days after intervention
measure: Serum total antioxidant capacity levels
timeFrame: From the start of the study to seven days after intervention
measure: Serum malondialdehyde levels
timeFrame: From the start of the study to seven days after intervention
measure: Aqueous ascorbic acid levels
timeFrame: Right before phacoemulsification
measure: Aqueous total antioxidant capacity levels
timeFrame: Right before phacoemulsification
measure: Aqueous malondialdehyde levels
timeFrame: Right before phacoemulsification to 3 minutes after phacoemulsification
measure: Central corneal thickness
timeFrame: rom the start of the study to six weeks after intervention
measure: Grading of cells in anterior chamber
timeFrame: From the start of the study to six weeks after intervention
measure: Visual acuity of patients
timeFrame: From the start of the study to six weeks after intervention
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Pharmacology Laboratory of the University of Indonesia
state: DKI Jakarta
city: Cianjur
country: Indonesia
facility: RSUD Sayang
state: West Java
Study officials:
References: