Effect of Vitamin C Supplementation in Corneal Endothelial Damage in Phacoemulsification of Patients with Hard Cataracts
NCT ID: NCT06781970
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-12-07
2025-06-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Vit C
Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification
Oral Vitamin C
Patients will be given 500 mg of oral vitamin C, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification
Preoperative Vit C
Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification and placebo, tid, 4 weeks after phacoemulsification
Oral Vitamin C
Patients will be given 500 mg of oral vitamin C, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification
Placebo
Patients will be given placebo, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification
Placebo
Patient will consume placebo, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification
Placebo
Patients will be given placebo, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification
Interventions
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Oral Vitamin C
Patients will be given 500 mg of oral vitamin C, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification
Placebo
Patients will be given placebo, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
60 Years
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Melva Louisa
Prof. dr. Melva Louisa, S.Si., M.Biomed
Locations
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Pharmacology Laboratory of the University of Indonesia
Jakarta, DKI Jakarta, Indonesia
RSUD Sayang
Cianjur, West Java, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-08-1198
Identifier Type: -
Identifier Source: org_study_id
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