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The Effect Of Tropical Fruits In Patients With Primary Glaucoma

Primary Purpose

Primary Glaucoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tropical fruits
Sponsored by
Hospital Universiti Sains Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Primary Glaucoma

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group A

    Group B

    Arm Description

    patient will be consuming the chosen fruits

    patient will consume normal diet as usual

    Outcomes

    Primary Outcome Measures

    intraocular pressure
    tonometer
    retinal nerve fibre layer
    Spectral domain Cirrus HD-OCT

    Secondary Outcome Measures

    Full Information

    First Posted
    October 1, 2023
    Last Updated
    October 1, 2023
    Sponsor
    Hospital Universiti Sains Malaysia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06071494
    Brief Title
    The Effect Of Tropical Fruits In Patients With Primary Glaucoma
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    May 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Universiti Sains Malaysia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Glaucoma

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    102 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    patient will be consuming the chosen fruits
    Arm Title
    Group B
    Arm Type
    No Intervention
    Arm Description
    patient will consume normal diet as usual
    Intervention Type
    Other
    Intervention Name(s)
    Tropical fruits
    Intervention Description
    papaya, mango, banana, orange
    Primary Outcome Measure Information:
    Title
    intraocular pressure
    Description
    tonometer
    Time Frame
    baseline, at 1 month , at 3 months and 6 months
    Title
    retinal nerve fibre layer
    Description
    Spectral domain Cirrus HD-OCT
    Time Frame
    baseline, at 1 month , at 3 months and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    nurul munirah mohamad
    Phone
    +60105755517
    Email
    nurulmunira8987@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    nurul munirah mohamad
    Organizational Affiliation
    Department of Ophthalmology School of Medical Sciences Universiti Sains Malaysia,Health Campus.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15158634
    Citation
    Weinreb RN, Khaw PT. Primary open-angle glaucoma. Lancet. 2004 May 22;363(9422):1711-20. doi: 10.1016/S0140-6736(04)16257-0.
    Results Reference
    background
    PubMed Identifier
    28933356
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26767881
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10449799
    Citation
    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.
    Results Reference
    background
    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov/15158634/
    Description
    Primary open-angle glaucoma
    URL
    https://pubmed.ncbi.nlm.nih.gov/28933356/
    Description
    The Association between Dietary Intake of Antioxidants and Ocular Disease. Diseases
    URL
    https://pubmed.ncbi.nlm.nih.gov/26767881/
    Description
    Association of Dietary Nitrate Intake With Primary Open-Angle Glaucoma: A Prospective Analysis From the Nurses' Health Study and Health Professionals Follow-up Study
    URL
    https://pubmed.ncbi.nlm.nih.gov/10449799/
    Description
    Inhibition of nitric-oxide synthase 2 by aminoguanidine provides neuroprotection of retinal ganglion cells in a rat model of chronic glaucoma

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    The Effect Of Tropical Fruits In Patients With Primary Glaucoma

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