Endothelial Cell Loss, CornealNCT06781970
Effect of Vitamin C Supplementation in Corneal Endothelial Damage in Phacoemulsification of Patients with Hard Cataracts
A study testing Oral Vitamin C in people with Endothelial Cell Loss, Corneal and Cataract and Intraocular Lens (IOL) Surgery, run by Universitas Indonesia at 2 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Endothelial Cell Loss, Corneal, Cataract and Intraocular Lens (IOL) Surgery
- What is being tested?
- Oral Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesIndonesia
- Study dates
- 7 Dec 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia2 sites, 2 recruiting
- Recruiting
RSUD Sayang
Cianjur, West Java, 43216
- Not yet recruiting
Pharmacology Laboratory of the University of Indonesia
Jakarta, DKI Jakarta, 10430
Syska Widyawati, Master of Medical Education, +62 818473841, syska.widyawati@gmail.com
About this study
Official 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.
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:
- 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?
- How does oxidative stress (MDA levels) in the aqueous humour increase after oral vitamin C administration compared to no administration?
- Will there any changes in MDA levels in the aqueous humour and blood after oral vitamin C administration compared to no administration?
- Does MDA levels in the aqueous humour correlate with MDA levels in the blood?
Read more
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
- Being tested
- Oral Vitamin C, Placebo
- Keywords
- Cataract, Corneal Endothelial Damage, Phacoemulsification, Total Antioxidant Capacity, Ascorbic Acid, Vitamin C Supplementation, malondialdehyde
- Medical subject headings
- Corneal Endothelial Cell Loss, Cataract, Intraocular Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Vitamin CDrug
Also called ascorbic acid
Patients will be given 500 mg of oral vitamin C, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification
PlaceboDrug
Patients will be given placebo, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification
| Study group | Role | What they receive |
|---|---|---|
| Vit C | Experimental | Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification Receives: 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 Receives: Drug: Oral Vitamin C; Drug: Placebo |
| Placebo | Placebo comparator | Patient will consume placebo, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial cell loss
Difference of endothelial cell density before and after phacoemulsification
Measured: From the start of the study to six weeks after intervention
Secondary outcomes (9)
Serum ascorbic acid levels
Level of ascorbic acid in serum
Measured: From the start of the study to seven days after intervention
Serum total antioxidant capacity levels
Level of total antioxidant capacity in serum
Measured: From the start of the study to seven days after intervention
Serum malondialdehyde levels
Levels of malondialdehyde in serum
Measured: From the start of the study to seven days after intervention
Aqueous ascorbic acid levels
Level of aqueous ascorbic acid
Measured: Right before phacoemulsification
Aqueous total antioxidant capacity levels
Levels of total antioxidant capacity in aqueous humour
Measured: Right before phacoemulsification
Aqueous malondialdehyde levels
Levels of malondialdehyde in aqueous humour
Measured: Right before phacoemulsification to 3 minutes after phacoemulsification
Central corneal thickness
Thickness of the central part of the cornea
Measured: 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
Measured: 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
Measured: From the start of the study to six weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start7 Dec 2024
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endothelial Cell Loss, CornealStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melva Louisa, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781970
- Sponsor's protocol ID
- 24-08-1198
- Status last verified
- Jan 2025
- First submitted
- 17 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protection of patient data and privacy
Publications
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.
PubMed 42099442
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06781970
- Acronym / sponsor ID
- 24-08-1198
- Keywords
- Cataract, Corneal Endothelial Damage, Phacoemulsification, Total Antioxidant Capacity, Ascorbic Acid, Vitamin C Supplementation, malondialdehyde
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 7 Dec 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- How does oxidative stress (MDA levels) in the aqueous humour increase after oral vitamin C administration compared to no administration?
- Will there any changes in MDA levels in the aqueous humour and blood after oral vitamin C administration compared to no administration?
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vit C | Experimental | Drug: Oral Vitamin CPatient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification |
| Preoperative Vit C | Experimental | Drug: Oral Vitamin C, Drug: PlaceboPatient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification and placebo, tid, 4 weeks after phacoemulsification |
| Placebo | Placebo comparator | Drug: PlaceboPatient will consume placebo, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Vitamin CAlso: ascorbic acidPatients will be given 500 mg of oral vitamin C, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification | Drug | Preoperative Vit C, Vit C |
| PlaceboPatients will be given placebo, tid, for 7 days prior to phacoemulsification and 4 weeks after phacoemulsification | Drug | Placebo, Preoperative Vit C |
Primary outcome
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
9 secondary outcomes
Serum ascorbic acid levels
Time frame: From the start of the study to seven days after intervention
Serum total antioxidant capacity levels
Time frame: From the start of the study to seven days after intervention
Serum malondialdehyde levels
Time frame: From the start of the study to seven days after intervention
Aqueous ascorbic acid levels
Time frame: Right before phacoemulsification
Aqueous total antioxidant capacity levels
Time frame: Right before phacoemulsification
Aqueous malondialdehyde levels
Time frame: Right before phacoemulsification to 3 minutes after phacoemulsification
Central corneal thickness
Time frame: rom the start of the study to six weeks after intervention
Grading of cells in anterior chamber
Time frame: From the start of the study to six weeks after intervention
Visual acuity of patients
Time frame: From the start of the study to six weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Derived from this study: PubMed 42099442Widyawati 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.
- Individual participant dataSharing planned: No. Protection of patient data and privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Vitamin C in people with Endothelial Cell Loss, Corneal and Cataract and Intraocular Lens (IOL) Surgery, run by Universitas Indonesia at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syska Widyawati, Master of Medical Education (+62 818473841, syska.widyawati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial cell loss (time frame: From the start of the study to six weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06781970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.