Primary Open Angle GlaucomaNCT04430296
Cyclophotocoagulation in Primary Open Angle Glaucoma
A study testing Cyclophotocoagulation in people with Primary Open Angle Glaucoma, run by Cairo University.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Cyclophotocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medically uncontrolled, primary open angle glaucoma attending glaucoma clinic
Who cannot join
- patients with history of previous laser or surgical intervention
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Low Power Continuous Wave Versus Micro Pulse Diode Versus High Intensity Focused Ultrasound Cyclophotocoagulation in Primary Open Angle Glaucoma
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.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Cyclophotocoagulation
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophotocoagulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU) | Active comparator | Not described Receives: Procedure: Cyclophotocoagulation |
| MicroPulse cyclophotocoagulation (MP-CPC) | Active comparator | Not described Receives: Procedure: Cyclophotocoagulation |
| Continuous Wave cyclophotocoagulation (CW-CPC) | Active comparator | Not described Receives: Procedure: Cyclophotocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Frequency of complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abdussalam abdullatif, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430296
- Sponsor's protocol ID
- 18/5/2020-1
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Power Continuous Wave Versus Micro Pulse Diode Versus High Intensity Focused Ultrasound Cyclophotocoagulation in Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT04430296
- Acronym / sponsor ID
- 18/5/2020-1
- Conditions
- Primary Open Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU) | Active comparator | Procedure: Cyclophotocoagulation |
| MicroPulse cyclophotocoagulation (MP-CPC) | Active comparator | Procedure: Cyclophotocoagulation |
| Continuous Wave cyclophotocoagulation (CW-CPC) | Active comparator | Procedure: Cyclophotocoagulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- medically uncontrolled, primary open angle glaucoma attending glaucoma clinic
Key exclusion criteria (1 listed)
- patients with history of previous laser or surgical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophotocoagulationHigh 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. | Procedure or surgery | Continuous Wave cyclophotocoagulation (CW-CPC), High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU), MicroPulse cyclophotocoagulation (MP-CPC) |
Primary outcome
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.
1 secondary outcome
Frequency of complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclophotocoagulation in people with Primary Open Angle Glaucoma, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Abdelrahman, MD (00201227394861, ahmed.mostafa@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.