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NCT04430296 Clinical Trial

Cyclophotocoagulation in Primary Open Angle Glaucoma

Primary Open Angle Glaucoma Clinical Trial

Official title:
Low Power Continuous Wave Versus Micro Pulse Diode Versus High Intensity Focused Ultrasound Cyclophotocoagulation in Primary Open Angle Glaucoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04430296
Other study ID # 18/5/2020-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date August 1, 2021

Study information
Verified date June 2020
Source Cairo University
Contact Ahmed M Abdelrahman, MD
Phone 00201227394861
Email ahmed.mostafa@kasralainy.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 78
Est. completion date August 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- medically uncontrolled, primary open angle glaucoma attending glaucoma clinic

Exclusion Criteria:

- patients with history of previous laser or surgical intervention

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 6 months
Secondary Frequency of complications 6 months
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