The Effect Of Tropical Fruits In Patients With Primary Glaucoma

Sponsor
Hospital Universiti Sains Malaysia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06071494
Collaborator
(none)
102
2
19

Study Details

Study Description

Brief Summary

To evaluate the effect of regular tropical fruits intake in primary glaucoma patients.

research hypothesis

  1. 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.

  2. 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

  1. Ophthalmology Clinic , Hospital Tengku Ampuan Afzan, Kuantan, Pahang

  2. Ophthalmology Clinic, Hospital Raja Perempuan Zainab, Kota Bharu, Kelantan

  3. Ophthalmology Clinic, Hospital Universiti Sains Malaysia, Kelantan

Source Reference Population Adults with primary glaucoma in Peninsular Malaysia

Condition or Disease Intervention/Treatment Phase
  • Other: Tropical fruits
N/A

Detailed Description

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

  1. 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.

  2. 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

  1. Ophthalmology Clinic , Hospital Tengku Ampuan Afzan, Kuantan, Pahang

  2. Ophthalmology Clinic, Hospital Raja Perempuan Zainab, Kota Bharu, Kelantan

  3. 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

  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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Other
Official Title:
A Randomized Controlled Trial Of The Effect Of Tropical Fruits On Intraocular Pressure And Retinal Nerve Fibre Layer Thickness In Patients With Primary Glaucoma
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

patient will be consuming the chosen fruits

Other: Tropical fruits
papaya, mango, banana, orange

No Intervention: Group B

patient will consume normal diet as usual

Outcome Measures

Primary Outcome Measures

  1. intraocular pressure [baseline, at 1 month , at 3 months and 6 months]

    tonometer

  2. retinal nerve fibre layer [baseline, at 1 month , at 3 months and 6 months]

    Spectral domain Cirrus HD-OCT

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hospital Universiti Sains Malaysia

Investigators

  • Principal Investigator: nurul munirah mohamad, Department of Ophthalmology School of Medical Sciences Universiti Sains Malaysia,Health Campus.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
NURUL MUNIRAH BINTI MOHAMAD, doctor, Hospital Universiti Sains Malaysia
ClinicalTrials.gov Identifier:
NCT06071494
Other Study ID Numbers:
  • RSCH ID-23-03744-7U6
First Posted:
Oct 6, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2023