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.

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

Study Overview

• Status: Recruiting
• Conditions: Endothelial Cell Loss, Corneal; Cataract and Intraocular Lens (IOL) Surgery
• Intervention / Treatment: Drug: Oral Vitamin C; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Syska Widyawati, Master of Medical Education; Phone Number: +62 818473841; Email: syska.widyawati@gmail.com
• Study Contact Backup: Name: Rafida Kamila, Medical Doctor; Phone Number: +62 81217169169; Email: rafida.sofi1997@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Not yet recruiting
      • Pharmacology Laboratory of the University of Indonesia
      • Contact: Syska Widyawati, Master of Medical Education; Phone Number: +62 818473841; Email: syska.widyawati@gmail.com
  • West Java
    • Cianjur, West Java, Indonesia, 43216
      • Recruiting
      • RSUD Sayang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vit C; Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification	Drug: 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; Other Names: ascorbic acid
Experimental: 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	Drug: 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; Other Names: ascorbic acid; Drug: Placebo; Patients will be given placebo, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification
Placebo Comparator: Placebo; Patient will consume placebo, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification	Drug: Placebo; Patients will be given placebo, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial cell loss	Difference of endothelial cell density before and after phacoemulsification	From the start of the study to six weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum ascorbic acid levels	Level of ascorbic acid in serum	From the start of the study to seven days after intervention
Serum total antioxidant capacity levels	Level of total antioxidant capacity in serum	From the start of the study to seven days after intervention
Serum malondialdehyde levels	Levels of malondialdehyde in serum	From the start of the study to seven days after intervention
Aqueous ascorbic acid levels	Level of aqueous ascorbic acid	Right before phacoemulsification
Aqueous total antioxidant capacity levels	Levels of total antioxidant capacity in aqueous humour	Right before phacoemulsification
Aqueous malondialdehyde levels	Levels of malondialdehyde in aqueous humour	Right before phacoemulsification to 3 minutes after phacoemulsification
Central corneal thickness	Thickness of the central part of the cornea	rom the start of the study to six weeks after intervention
Grading of cells in anterior chamber	Collection of white blood cells in the anterior chamber	From the start of the study to six weeks after intervention
Visual acuity of patients	A measure of the ability of the eye to distinguish shapes and the details of objects at a given distance	From the start of the study to six weeks after intervention

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Cataract; Ascorbic Acid; Phacoemulsification; malondialdehyde; Total Antioxidant Capacity; Corneal Endothelial Damage; Vitamin C Supplementation
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Eye Diseases; Corneal Diseases; Lens Diseases; Eye Manifestations; Cataract; Corneal Endothelial Cell Loss; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Antioxidants; Protective Agents; Vitamins; Ascorbic Acid
• Other Study ID Numbers: 24-08-1198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Protection of patient data and privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No