Vitamin C's effect on corneal health during cataract surgery
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.
NA · Indonesia University · NCT06781970
This study is testing if taking vitamin C before and after cataract surgery can help protect the eye and reduce damage to the cornea compared to a placebo.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Indonesia University (other) |
| Locations | 2 sites (Jakarta, DKI Jakarta and 1 other locations) |
| Trial ID | NCT06781970 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the protective effects of oral vitamin C on the corneal endothelial layer during phacoemulsification surgery for patients with hard cataracts. It aims to determine whether preoperative and postoperative vitamin C administration can reduce oxidative stress and endothelial cell loss compared to a placebo. The study will measure levels of malondialdehyde (MDA) in the aqueous humor and blood to assess oxidative stress and its correlation with vitamin C intake. Participants will be monitored for 7 weeks post-surgery to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 60 years or older with immature senile cataracts and specific lens opacity criteria.
Not a fit: Patients with a history of previous intraocular surgery or allergies to vitamin C may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved corneal health and reduced endothelial damage in patients undergoing cataract surgery.
How similar studies have performed: While the specific application of vitamin C in this context is novel, antioxidant therapies have shown promise in other studies related to oxidative stress in ocular conditions.
Eligibility criteria
Show full inclusion / exclusion 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: \-
Where this trial is running
Jakarta, DKI Jakarta and 1 other locations
- Pharmacology Laboratory of the University of Indonesia — Jakarta, DKI Jakarta, Indonesia (NOT_YET_RECRUITING)
- RSUD Sayang — Cianjur, West Java, Indonesia (RECRUITING)
Study contacts
- Study coordinator: Syska Widyawati, Master of Medical Education
- Email: syska.widyawati@gmail.com
- Phone: +62 818473841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endothelial Cell Loss, Corneal, Cataract and Intraocular Lens Surgery, Cataract, Corneal Endothelial Damage, Phacoemulsification, Total Antioxidant Capacity, Ascorbic Acid, Vitamin C Supplementation