The Effect Of Tropical Fruits In Patients With Primary Glaucoma

Study Overview
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Brief Summary
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To evaluate the effect of regular tropical fruits intake in primary glaucoma patients. research hypothesis There is a significant different in the eye pressure measurement between those whose taking regular tropical fruits and not taking them at baseline, 1 month, 3 month and 6 month among patients with primary glaucoma. There is a significant different in retinal nerve fibre layer thickness between those whose taking regular tropical fruits and not taking them at baseline, 1 month, 3 month and 6 month among patients with primary glaucoma. Study Duration August 2023-June 2025 Study Location Ophthalmology Clinic , Hospital Tengku Ampuan Afzan, Kuantan, Pahang Ophthalmology Clinic, Hospital Raja Perempuan Zainab, Kota Bharu, Kelantan Ophthalmology Clinic, Hospital Universiti Sains Malaysia, Kelantan Source Reference Population Adults with primary glaucoma in Peninsular Malaysia

Detailed Description
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A RANDOMIZED CONTROLLED TRIAL OF THE EFFECT OF TROPICAL FRUITS ON INTRAOCULAR PRESSURE AND RETINAL NERVE FIBRE LAYER THICKNESS IN PATIENTS WITH PRIMARY GLAUCOMA General objective To evaluate the effect of regular tropical fruits intake on intra-ocular pressure (IOP) and retinal nerve fibre layer thickness (RNFL) in primary glaucoma patients. Research hypothesis There is a significant different in the IOP measurement between those whose taking regular tropical fruits and not taking them at baseline, 1 month, 3 month and 6 month among patients with primary glaucoma. There is a significant different in RNFL thickness between those whose taking regular tropical fruits and not taking them at baseline, 1 month, 3 month and 6 month among patients with primary glaucoma. Methodology : Research Design Randomized controlled trial Study Duration August 2023-June 2025 Study Location Ophthalmology Clinic , Hospital Tengku Ampuan Afzan, Kuantan, Pahang Ophthalmology Clinic, Hospital Raja Perempuan Zainab, Kota Bharu, Kelantan Ophthalmology Clinic, Hospital Universiti Sains Malaysia, Kelantan Source Reference Population Adults with primary glaucoma in Peninsular Malaysia Study Source Population Adults with primary glaucoma attending Ophthalmology Clinic Hospital Tengku Ampuan Afzan, Kuantan, Pahang, Ophthalmology Clinic Hospital Raja Perempuan Zainab, Kota Bharu, Kelantan and Ophthalmology clinic, Hospital Universiti Sains Malaysia during study duration. Inclusion Criteria Patient with confirmed diagnosis of POAG and PACG Patient on medical treatment and achieved target IOP in last 6 months Good compliance with pressure lowering agents Exclusion Criteria Poorly controlled diabetes mellitus, hypertension and hyperlipidaemia Active smoker Mentally challenge based on diagnosis History of previous intraocular surgery other than uncomplicated cataract surgery within past 6 months Poor signal strength OCT RNFL 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 Other optic neuropathy apart from glaucoma History of taking antioxidant supplement 3 months prior to recruitment.

Official Title
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A Randomized Controlled Trial Of The Effect Of Tropical Fruits On Intraocular Pressure And Retinal Nerve Fibre Layer Thickness In Patients With Primary Glaucoma

Conditions
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Primary Glaucoma

Intervention / Treatment
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* Other: Tropical fruits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with confirmed diagnosis of POAG and PACG Patient on medical treatment and achieved target IOP in last 6 months Good compliance with pressure lowering agents Exclusion Criteria: Poorly controlled diabetes mellitus, hypertension and hyperlipidaemia Active smoker Mentally challenge based on diagnosis History of previous intraocular surgery other than uncomplicated cataract surgery within past 6 months Poor signal strength OCT RNFL 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 Other optic neuropathy apart from glaucoma History of taking antioxidant supplement 3 months prior to recruitment

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>patient will be consuming the chosen fruits | Other: Tropical fruits<br>* papaya, mango, banana, orange<br>|
| No Intervention: Group B<br>patient will consume normal diet as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure | tonometer | baseline, at 1 month , at 3 months and 6 months | 
| retinal nerve fibre layer | Spectral domain Cirrus HD-OCT | baseline, at 1 month , at 3 months and 6 months |