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Cyclophotocoagulation in Primary Open Angle Glaucoma

Primary Purpose

Primary Open Angle Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cyclophotocoagulation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • medically uncontrolled, primary open angle glaucoma attending glaucoma clinic

Exclusion Criteria:

  • patients with history of previous laser or surgical intervention

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU)

    MicroPulse cyclophotocoagulation (MP-CPC)

    Continuous Wave cyclophotocoagulation (CW-CPC)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Success rate.
    The success will be defined as IOP between 6 and 21 mmHg and at least a 30% reduction in IOP with or without topical IOP lowering medications.

    Secondary Outcome Measures

    Frequency of complications

    Full Information

    First Posted
    June 10, 2020
    Last Updated
    June 10, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04430296
    Brief Title
    Cyclophotocoagulation in Primary Open Angle Glaucoma
    Official Title
    Low Power Continuous Wave Versus Micro Pulse Diode Versus High Intensity Focused Ultrasound Cyclophotocoagulation in Primary Open Angle Glaucoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2021 (Anticipated)
    Study Completion Date
    August 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    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
    The use of Cyclodestruction procedures has been extended to patients with non-refractory glaucoma and good vision. Our aim is to compare the safety and efficacy of three cyclodestructive treatments; High Intensity Focused Ultrasound (HIFU) Cyclocoagulation versus micropulse cyclophotocoagulation (MP-CPC) versus transscleral continuous wave cyclophotocoagulation (CW-CPC) for the treatment of Primary open angle glaucoma.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    78 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU)
    Arm Type
    Active Comparator
    Arm Title
    MicroPulse cyclophotocoagulation (MP-CPC)
    Arm Type
    Active Comparator
    Arm Title
    Continuous Wave cyclophotocoagulation (CW-CPC)
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Cyclophotocoagulation
    Intervention Description
    High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU): parameters: 21 MHz frequency, 2.45 W acoustic power, with the activation of each transducer lasting 6 seconds MicroPulse cyclophotocoagulation (MP-CPC):Laser settings of 2 Watts (W) will be applied for a 90 seconds treatment time for each 180 degrees, with a duty cycle of 31.3%, which consists of 0.5ms "on time" and 1.1 ms "off-time" and delivering a total of 112,7 Joules Continuous Wave cyclophotocoagulation (CW-CPC): The laser settings used will be 1.250 W, 4s exposure time per burn, 22-24 burns per eye.
    Primary Outcome Measure Information:
    Title
    Success rate.
    Description
    The success will be defined as IOP between 6 and 21 mmHg and at least a 30% reduction in IOP with or without topical IOP lowering medications.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Frequency of complications
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: medically uncontrolled, primary open angle glaucoma attending glaucoma clinic Exclusion Criteria: patients with history of previous laser or surgical intervention
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed M Abdelrahman, MD
    Phone
    00201227394861
    Email
    ahmed.mostafa@kasralainy.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heba M ElSaied, MD
    Phone
    00201224645060
    Email
    hebamagdy13@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Cyclophotocoagulation in Primary Open Angle Glaucoma

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