Antioxidant Support for the Corneal Endothelium: Evidence from Vitamin C Supplementation in Hard Cataract Phacoemulsification.
Syska Widyawati, Ratna Sitompul, Septelia I Wanandi...
https://pubmed.ncbi.nlm.nih.gov/42099442Actively Recruiting
Phase Not Applicable
Age: 60Years +
All Genders
ID06781970
The Effects of Vitamin C Supplementation on Corneal Endothelial Damage in Hard Cataract Phacoemulsification Surgery An Oxidative Stress Study on Eye Fluid and Corneal Cell Characteristics
Led by Indonesia University · Updated on 2025-01-17
120
Participants Needed
2
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the protective effects of oral vitamin C on the corneal endothelial layer in patients undergoing phacoemulsification for hard cataracts. The study aims to find out if vitamin C taken before and after surgery helps protect the cornea better than taking it only before surgery or not at all. They will also examine how oxidative stress markers (MDA levels) in the eye fluid and blood change with vitamin C compared to a placebo. Participants will be assigned to take either 500 mg of oral vitamin C or a placebo three times a day, starting seven days before the cataract surgery and continuing for 28 days after. The main procedure, phacoemulsification, will be performed during the study. Participants will be monitored through several follow-up visits at 1, 7, 28, and 42 days after surgery. Throughout the study, participants will keep a log to record their medication intake and any side effects. Researchers will assess corneal endothelial cell loss from the start to six weeks after the intervention, along with measuring oxidative stress markers in eye fluid and blood. The total participation period covers about seven weeks, including treatment and follow-up evaluations.
CONDITIONS
Official Title
Effect of Vitamin C Supplementation in Corneal Endothelial Damage in Phacoemulsification of Patients with Hard Cataracts
Who Can Participate
Age: 60Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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1
2
3
Trial Site Locations
Total: 2 locations
1
Pharmacology Laboratory of the University of Indonesia
Jakarta, DKI Jakarta, Indonesia, 10430
Not Yet Recruiting
2
RSUD Sayang
Cianjur, West Java, Indonesia, 43216
Actively Recruiting
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Research Team
S
Syska Widyawati, Master of Medical Education
R
Rafida Kamila, Medical Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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