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Comparison Between Two Techniques of Subthreshold Diode Laser Cyclophotocoagulation in Refractory Glaucoma

Primary Purpose

Refractory Glaucoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
360 degrees subthreshold diode laser cyclophotocoagulation
180 degrees subthreshold diode laser cyclophotocoagulation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Glaucoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients with refractory glaucoma (IOP > 21 mmHg unresponsive to maximally tolerated antiglaucoma medications, previously failed surgical treatment, or both)

Exclusion Criteria:

  • Ocular inflammation.
  • Ocular infection.
  • Recent ocular surgery in the study eye in the 2 months prior to enrolment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    group A the standard technique

    Group B a modified technique

    Arm Description

    cyclophotocoagulation is applied along the upper and lower hemispheres over pars plana -3 mm behind the limbus

    cyclophotocoagulation is applied over one hemisphere only (180 degrees) along pars plana-3 mm behind the limbus- followed by a second application over pars plicata-1.2 mm behind the limbus- along the same hemisphere (ie, in a double arc fashion).

    Outcomes

    Primary Outcome Measures

    IOP reduction success rate
    Success rate is defined as achieving an IOP between 5 and 21 mmHg or at least a 20% reduction in IOP at the final follow up with or without IOP lowering medications

    Secondary Outcome Measures

    Full Information

    First Posted
    January 20, 2022
    Last Updated
    February 5, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05230355
    Brief Title
    Comparison Between Two Techniques of Subthreshold Diode Laser Cyclophotocoagulation in Refractory Glaucoma
    Official Title
    Comparison Between Two Techniques of Subthreshold Diode Laser Cyclophotocoagulation in Refractory Glaucoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2022 (Anticipated)
    Primary Completion Date
    February 1, 2024 (Anticipated)
    Study Completion Date
    February 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut 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 aim of this study is to assess the results of subliminal subthreshold transscleral diode cyclophotocoagulation in refractory glaucoma using the standard technique of 360 degree application and to compare the outcome with a modified technique both in terms of efficacy and safety.
    Detailed Description
    Refractory glaucoma is glaucoma that doesn't respond favorably to surgical and/or medical treatment to lower intraocular pressure. It can include primary open angle glaucoma, primary angle closure glaucoma, neovascular glaucoma or silicone oil-induced glaucoma. Cyclophotocoagulation (CPC) is a form of cycloablation using laser to treat glaucoma. It involves ciliary body destruction by targeting the ciliary epithelium and stroma, resulting in a reduction in aqueous secretion and hence intraocular pressure. Transscleral cyclophotocoagulation using a continuous diode laser has been a treatment option in advanced glaucoma cases with s¬¬uboptimal IOP control, for a long time. High treatment energy used by diode laser cyclophotocoagulation was argued to be associated with increased frequency of serious complications such as vision loss, hypotony, and phthisis. These concerns necessitate modulation of the parameters of laser treatment used. Micropulse transscleral cyclophotocoagulation (MP-TSCPC), which is a variation of conventional continuous-wave CPC, has emerged as an attractive alternative for the treatment of many types of glaucoma. It breaks the continuous wave laser into multiple short and repetitive pulses that allow the tissue to cool down between applications, thus reducing thermal damage. This strategy delivers very short energy pulses followed by rest periods, which is known as "duty cycle" and is defined as the ratio of time that a laser is delivering energy vs resting (ON/OFF). For this procedure, an infrared diode laser is used to stimulate the ciliary body structures and the uveoscleral pathway. This way it reduces the production of the aqueous humour and facilitates the uveoscleral outflow, with IOP reduction as a final effect. Despite promising results, only few clinical studies are published on MP-TSCPC and most of them are retrospective studies refer to patients having previous continuous wave transscleral cyclophotocoagulation. Moreover, Several parameters and protocols have been studied in other reports in an attempt to refine the standard technique aiming to improve the outcomes without increasing the adverse effects.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group A the standard technique
    Arm Type
    Active Comparator
    Arm Description
    cyclophotocoagulation is applied along the upper and lower hemispheres over pars plana -3 mm behind the limbus
    Arm Title
    Group B a modified technique
    Arm Type
    Active Comparator
    Arm Description
    cyclophotocoagulation is applied over one hemisphere only (180 degrees) along pars plana-3 mm behind the limbus- followed by a second application over pars plicata-1.2 mm behind the limbus- along the same hemisphere (ie, in a double arc fashion).
    Intervention Type
    Device
    Intervention Name(s)
    360 degrees subthreshold diode laser cyclophotocoagulation
    Intervention Description
    cyclophotocoagulation is applied along 360 degrees over pars plana
    Intervention Type
    Device
    Intervention Name(s)
    180 degrees subthreshold diode laser cyclophotocoagulation
    Intervention Description
    cyclophotocoagulation is applied over one hemisphere only along 180 degrees in a double arc fashion
    Primary Outcome Measure Information:
    Title
    IOP reduction success rate
    Description
    Success rate is defined as achieving an IOP between 5 and 21 mmHg or at least a 20% reduction in IOP at the final follow up with or without IOP lowering medications
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients with refractory glaucoma (IOP > 21 mmHg unresponsive to maximally tolerated antiglaucoma medications, previously failed surgical treatment, or both) Exclusion Criteria: Ocular inflammation. Ocular infection. Recent ocular surgery in the study eye in the 2 months prior to enrolment.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparison Between Two Techniques of Subthreshold Diode Laser Cyclophotocoagulation in Refractory Glaucoma

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