Cyclophotocoagulation in Primary Open Angle Glaucoma
Low Power Continuous Wave Versus Micro Pulse Diode Versus High Intensity Focused Ultrasound Cyclophotocoagulation in Primary Open Angle Glaucoma
1 other identifier
interventional
78
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedJune 12, 2020
June 1, 2020
7 months
June 10, 2020
June 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Frequency of complications
6 months
Study Arms (3)
High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU)
ACTIVE COMPARATORMicroPulse cyclophotocoagulation (MP-CPC)
ACTIVE COMPARATORContinuous Wave cyclophotocoagulation (CW-CPC)
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- medically uncontrolled, primary open angle glaucoma attending glaucoma clinic
You may not qualify if:
- patients with history of previous laser or surgical intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
June 10, 2020
First Posted
June 12, 2020
Study Start
August 1, 2020
Primary Completion
March 1, 2021
Study Completion
August 1, 2021
Last Updated
June 12, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share