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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vit C | Experimental | Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification |
|
| 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 |
|
| Placebo | Placebo Comparator | Patient will consume placebo, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Syska Widyawati, Master of Medical Education | Contact | +62 818473841 | syska.widyawati@gmail.com | |
| Rafida Kamila, Medical Doctor | Contact | +62 81217169169 | rafida.sofi1997@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmacology Laboratory of the University of Indonesia | Not yet recruiting | Jakarta | DKI Jakarta | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42099442 | Derived | Widyawati 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. |
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Protection of patient data and privacy
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|
| Placebo | Drug | Patients will be given placebo, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification |
|
| 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 |
| RSUD Sayang | Recruiting | Cianjur | West Java | 43216 | Indonesia |
| ID | Term |
|---|---|
| D055954 | Corneal Endothelial Cell Loss |
| D002386 | Cataract |
| D064090 | Intraocular Lymphoma |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D005132 | Eye Manifestations |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D007905 | Lens Diseases |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
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