Effect of tropical fruits on primary glaucoma patients
A Randomized Controlled Trial Of The Effect Of Tropical Fruits On Intraocular Pressure And Retinal Nerve Fibre Layer Thickness In Patients With Primary Glaucoma
This study is testing whether eating tropical fruits can help people with primary glaucoma by looking at changes in eye pressure and nerve health over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 1 site (Kubang Kerian, Kota Bharu) |
| Trial ID | NCT06071494 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of regular intake of tropical fruits on patients diagnosed with primary glaucoma. It will assess changes in intra-ocular pressure (IOP) and retinal nerve fiber layer (RNFL) thickness over a period of six months. The study will involve a randomized controlled design, comparing outcomes between participants consuming tropical fruits and those who do not. Data will be collected at baseline, one month, three months, and six months to determine the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a confirmed diagnosis of primary open-angle glaucoma (POAG) or primary angle-closure glaucoma (PACG) who are compliant with their medical treatment.
Not a fit: Patients with poorly controlled diabetes, hypertension, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary approach to managing primary glaucoma, potentially improving patient outcomes.
How similar studies have performed: While the specific approach of using tropical fruits is novel, dietary interventions have shown promise in other studies related to glaucoma management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient with confirmed diagnosis of POAG and PACG 2. Patient on medical treatment and achieved target IOP in last 6 months 3. Good compliance with pressure lowering agents Exclusion Criteria: 1. Poorly controlled diabetes mellitus, hypertension and hyperlipidaemia 2. Active smoker 3. Mentally challenge based on diagnosis 4. History of previous intraocular surgery other than uncomplicated cataract surgery within past 6 months 5. Poor signal strength OCT RNFL 6. Patient with media opacities that affect the reliability of OCT measurements , such as Cornea opacity, dense cataract with LOCS III of more than grade 2, vitreous haemorrhage 7. Other optic neuropathy apart from glaucoma 8. History of taking antioxidant supplement 3 months prior to recruitment
Where this trial is running
Kubang Kerian, Kota Bharu
- Univerisiti Sains Malaysia — Kubang Kerian, Kota Bharu, Malaysia (Recruiting)
Study contacts
- Principal investigator: Nurul Munirah Mohamad, Dr — Department of Ophthalmology School of Medical Sciences Universiti Sains Malaysia,Health Campus.
- Study coordinator: Nurul Munirah Mohamad, Dr
- Email: nurulmunirah8987@gmail.com
- Phone: +60105755517
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.