The Effect Of Tropical Fruits In Patients With Primary Glaucoma

NCT06071494 | Completed

• 1 other identifier: RSCH ID-23-03744-7U6
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of regular tropical fruits intake in primary glaucoma patients. Methodology : Research Design Randomized controlled trial Study Duration February 2024-June 2025 Study Location 1\. 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 Universiti Sains Malaysia during study duration.

Conditions

Primary Glaucoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Tropical Fruits

EXPERIMENTAL

patient will be consuming the chosen fruits, according to the size of the serving following Malaysian Dietary Guideline 2020

Other: Tropical fruits

Normal diet

NO INTERVENTION

patient will consume normal diet as usual

Interventions

Tropical fruits OTHER

papaya, mango, banana, orange

Tropical Fruits

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Univerisiti Sains Malaysia

Kubang Kerian, Kota Bharu, 16150, Malaysia

Location

Related Publications (4)

• Weinreb RN, Khaw PT. Primary open-angle glaucoma. Lancet. 2004 May 22;363(9422):1711-20. doi: 10.1016/S0140-6736(04)16257-0.

  PMID: 15158634 BACKGROUND

• Braakhuis A, Raman R, Vaghefi E. The Association between Dietary Intake of Antioxidants and Ocular Disease. Diseases. 2017 Jan 30;5(1):3. doi: 10.3390/diseases5010003.

  PMID: 28933356 BACKGROUND

• Kang JH, Willett WC, Rosner BA, Buys E, Wiggs JL, Pasquale LR. Association of Dietary Nitrate Intake With Primary Open-Angle Glaucoma: A Prospective Analysis From the Nurses' Health Study and Health Professionals Follow-up Study. JAMA Ophthalmol. 2016 Mar;134(3):294-303. doi: 10.1001/jamaophthalmol.2015.5601.

  PMID: 26767881 BACKGROUND

• Neufeld AH, Sawada A, Becker B. Inhibition of nitric-oxide synthase 2 by aminoguanidine provides neuroprotection of retinal ganglion cells in a rat model of chronic glaucoma. Proc Natl Acad Sci U S A. 1999 Aug 17;96(17):9944-8. doi: 10.1073/pnas.96.17.9944.

  PMID: 10449799 BACKGROUND

Related Links

• Primary open-angle glaucoma
• The Association between Dietary Intake of Antioxidants and Ocular Disease. Diseases
• Association of Dietary Nitrate Intake With Primary Open-Angle Glaucoma: A Prospective Analysis From the Nurses' Health Study and Health Professionals Follow-up Study
• Inhibition of nitric-oxide synthase 2 by aminoguanidine provides neuroprotection of retinal ganglion cells in a rat model of chronic glaucoma

Study Officials

• Nurul Munirah Mohamad, Dr

  Department of Ophthalmology School of Medical Sciences Universiti Sains Malaysia,Health Campus.

  PRINCIPAL INVESTIGATOR

• Liza Sharmini Ahmad Tajudin, Prof. Dr.

  Department of Ophthalmology School of Medical Sciences Universiti Sains Malaysia,Health Campus.

  STUDY CHAIR

• Rohana Abd Jalil, Ass. Prof.

  Department of Ophthalmology School of Medical Sciences Universiti Sains Malaysia,Health Campus.

  STUDY DIRECTOR

• Fatimah Suhaila Sukaimy, Dr

  Department of Ophthalmology Hospital Tengku Ampuan Afzan, Ministry of Health, Malaysia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 6, 2023
• Study Start: February 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)