Effect of Vitamin C Supplementation in Corneal Endothelial Damage in Phacoemulsification of Patients with Hard Cataracts

NCT06781970 | Recruiting

• 1 other identifier: 24-08-1198
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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:

• 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

Endothelial Cell Loss, Corneal; Cataract and Intraocular Lens (IOL) Surgery

Keywords

Cataract; Corneal Endothelial Damage; Phacoemulsification; Total Antioxidant Capacity; Ascorbic Acid; Vitamin C Supplementation; malondialdehyde

Outcome Measures

Primary Outcomes (1)

• Endothelial cell loss

  Difference of endothelial cell density before and after phacoemulsification

  From the start of the study to six weeks after intervention

Secondary Outcomes (9)

• Serum ascorbic acid levels

  From the start of the study to seven days after intervention

• Serum total antioxidant capacity levels

  From the start of the study to seven days after intervention

• Serum malondialdehyde levels

  From the start of the study to seven days after intervention

• Aqueous ascorbic acid levels

  Right before phacoemulsification

• Aqueous total antioxidant capacity levels

  Right before phacoemulsification

Study Arms (3)

Vit C

EXPERIMENTAL

Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification

Drug: Oral Vitamin C

Preoperative Vit C

EXPERIMENTAL

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; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Patient will consume placebo, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification

Drug: Placebo

Interventions

Oral Vitamin C DRUG

Patients will be given 500 mg of oral vitamin C, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification

Also known as: ascorbic acid

Preoperative Vit C; Vit C

Placebo DRUG

Patients will be given placebo, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification

Placebo; Preoperative Vit C

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (2)

Pharmacology Laboratory of the University of Indonesia

Jakarta, DKI Jakarta, 10430, Indonesia

NOT YET RECRUITING

RSUD Sayang

Cianjur, West Java, 43216, Indonesia

RECRUITING

MeSH Terms

Conditions

Corneal Endothelial Cell Loss; Cataract; Intraocular Lymphoma

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Lens Diseases; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Eye Neoplasms; Neoplasms by Site; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Syska Widyawati, Master of Medical Education

CONTACT

+62 818473841; syska.widyawati@gmail.com

Rafida Kamila, Medical Doctor

CONTACT

+62 81217169169; rafida.sofi1997@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. Melva Louisa, S.Si., M.Biomed

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 17, 2025
• Study Start: December 7, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)