Clinical trial · Interventional
Effect of Vitamin C Supplementation in Corneal Endothelial Damage in Phacoemulsification of Patients with Hard Cataracts
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cataract and Intraocular Lens (IOL) Surgery | — | UNRESOLVED | — |
| Endothelial Cell Loss, Corneal | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Vitamin C | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Vit C
- description
- Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification
- interventionNames
- Drug: Oral Vitamin C
- type
- EXPERIMENTAL
- label
- Preoperative Vit C
- description
- Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification and placebo, tid, 4 weeks after phacoemulsification
- interventionNames
- Drug: Oral Vitamin C
- Drug: Placebo
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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: \-
References
Publications (1)
- DERIVEDWidyawati S, Sitompul R, I Wanandi S, Louisa M, Kekalih A, Ldr Nora R. Antioxidant Support for the Corneal Endothelium: Evidence from Vitamin C Supplementation in Hard Cataract Phacoemulsification. F1000Res. 2026 Apr 24;14:1117. doi: 10.12688/f1000research.170846.3. eCollection 2025. PMID 42099442