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NCT Number: NCT06781970

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

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

Recruiting

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Key information

Conditions

Endothelial Cell Loss, Corneal Cataract Cataract and Intraocular Lens (IOL) Surgery Corneal Diseases Corneal Endothelial Cell Loss Eye Diseases Eye Manifestations Eye Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intraocular Lymphoma Lens Diseases Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pharmacology Laboratory of the University of Indonesia, Jakarta, DKI Jakarta, Indonesia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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

Other names: ascorbic acid

Placebo

Drug

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

Primary outcomes

  1. Endothelial cell loss

    Time frame: From the start of the study to six weeks after intervention

    Difference of endothelial cell density before and after phacoemulsification

Secondary outcomes

  1. Serum ascorbic acid levels

    Time frame: From the start of the study to seven days after intervention

    Level of ascorbic acid in serum

  2. Serum total antioxidant capacity levels

    Time frame: From the start of the study to seven days after intervention

    Level of total antioxidant capacity in serum

  3. Serum malondialdehyde levels

    Time frame: From the start of the study to seven days after intervention

    Levels of malondialdehyde in serum

  4. Aqueous ascorbic acid levels

    Time frame: Right before phacoemulsification

    Level of aqueous ascorbic acid

  5. Aqueous total antioxidant capacity levels

    Time frame: Right before phacoemulsification

    Levels of total antioxidant capacity in aqueous humour

  6. Aqueous malondialdehyde levels

    Time frame: Right before phacoemulsification to 3 minutes after phacoemulsification

    Levels of malondialdehyde in aqueous humour

  7. Central corneal thickness

    Time frame: rom the start of the study to six weeks after intervention

    Thickness of the central part of the cornea

  8. Grading of cells in anterior chamber

    Time frame: From the start of the study to six weeks after intervention

    Collection of white blood cells in the anterior chamber

  9. Visual acuity of patients

    Time frame: From the start of the study to six weeks after intervention

    A measure of the ability of the eye to distinguish shapes and the details of objects at a given distance

Study contacts

Contact information is provided by the study sponsor or research team.

Rafida Kamila, Medical Doctor

CONTACT

[email protected]

+62 81217169169

Syska Widyawati, Master of Medical Education

CONTACT

[email protected]

+62 818473841

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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