Endothelial Cell Loss, Corneal, Cataract and Intraocular Lens (IOL) Surgery
Conditions
Keywords
Cataract, Corneal Endothelial Damage, Phacoemulsification, Total Antioxidant Capacity, Ascorbic Acid, Vitamin C Supplementation, malondialdehyde
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: 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
Interventions
DRUGOral Vitamin C
Patients will be given 500 mg of oral vitamin C, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification
DRUGPlacebo
Patients will be given placebo, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial cell loss | From the start of the study to six weeks after intervention | Difference of endothelial cell density before and after phacoemulsification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum total antioxidant capacity levels | From the start of the study to seven days after intervention | Level of total antioxidant capacity in serum |
| Serum malondialdehyde levels | From the start of the study to seven days after intervention | Levels of malondialdehyde in serum |
| Aqueous ascorbic acid levels | Right before phacoemulsification | Level of aqueous ascorbic acid |
| Aqueous total antioxidant capacity levels | Right before phacoemulsification | Levels of total antioxidant capacity in aqueous humour |
| Serum ascorbic acid levels | From the start of the study to seven days after intervention | Level of ascorbic acid in serum |
| Central corneal thickness | rom the start of the study to six weeks after intervention | Thickness of the central part of the cornea |
| Grading of cells in anterior chamber | From the start of the study to six weeks after intervention | Collection of white blood cells in the anterior chamber |
| Visual acuity of patients | 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 |
| Aqueous malondialdehyde levels | Right before phacoemulsification to 3 minutes after phacoemulsification | Levels of malondialdehyde in aqueous humour |
Countries
Indonesia
Contacts
Primary ContactSyska Widyawati, Master of Medical Education
Backup ContactRafida Kamila, Medical Doctor
Outcome results
None listed