Cyclophotocoagulation in Primary Open Angle Glaucoma

Overview

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.

Full Title of Study: “Low Power Continuous Wave Versus Micro Pulse Diode Versus High Intensity Focused Ultrasound Cyclophotocoagulation in Primary Open Angle Glaucoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 1, 2021

Interventions

  • Procedure: Cyclophotocoagulation
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU)
  • Active Comparator: MicroPulse cyclophotocoagulation (MP-CPC)
  • Active Comparator: Continuous Wave cyclophotocoagulation (CW-CPC)

Clinical Trial Outcome Measures

Primary Measures

  • Success rate.
    • Time Frame: 6 months
    • 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 Measures

  • Frequency of complications
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • medically uncontrolled, primary open angle glaucoma attending glaucoma clinic Exclusion Criteria:

  • patients with history of previous laser or surgical intervention

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: abdussalam abdullatif, MD, Lecturer – Cairo University
  • Overall Contact(s)
    • Ahmed M Abdelrahman, MD, 00201227394861, ahmed.mostafa@kasralainy.edu.eg

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