Angle Closure GlaucomaNCT05576493
Combined Phacoemulsification and Diode Laser Therapy in Chronic Angle Closure Glaucoma
A study testing phaco+MP-TSCPC, phaco+TSCPC and phaco+endocyclophotocoagulation in people with Angle Closure Glaucoma, run by Cairo University at 1 site in Egypt.
Trial summary
comparing different types of cuclophotocoagulation with cataract extraction to cataract extraction and goniocynechiolysis in cases of chronic angle closure glaucoma Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Angle Closure Glaucoma
- What is being tested?
- phaco+MP-TSCPC, phaco+TSCPC and phaco+endocyclophotocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Aug 2022to 1 Dec 2023
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 20 to 70 years
- chronic angle closure glaucoma
Who cannot join
- Patients in acute attack of angle closure.
- Patients with previous filtering surgery or cycloablative procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Phacoemulsification and Different Modes of Diode Laser Therapy in Management of Chronic Angle Closure Glaucoma. A Comparative Study
comparing different types of cuclophotocoagulation with cataract extraction to cataract extraction and goniocynechiolysis in cases of chronic angle closure glaucoma
Read the detailed description
Evaluation of the safety of MP-TSCPC , CW-TSCPC and endoscopic cyclophotocoagulation when combined with phacoemulsification in cases with CACG Comparing the efficacy of the combined procedures in control of the IOP and the success rate versus lens extraction combined with synechiolysis
- Conditions
- Angle Closure Glaucoma
- Being tested
- phaco+MP-TSCPC, phaco+TSCPC, phaco+endocyclophotocoagulation, phaco GSL
- Keywords
- angle closure glaucoma, cyclophotocoagulation
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phaco+MP-TSCPCProcedure or surgery
The procedure starts with performing the cyclophotocoagulation using the Micropulse P3 device (IQ 810 Laser Systems; Iridex, Mountain View, CA, USA) at 2500 mW with a duration of 90 seconds in each hemisphere at a 31.3% duty cycle under local anesthesia and then performing phacoemulsification and IOL implantation.
phaco+TSCPCProcedure or surgery
The procedure starts with performing the cyclophotocoagulation using the IRIDEX's G probe device (IRIDEX Corp. Mountain View, CA, USA) at 1500 to2000 mW with a duration of 1500 ms applying about 15 shots in one hemisphere only under local anesthesia and then performing phacoemulsification and IOL implantation.
phaco+endocyclophotocoagulationProcedure or surgery
phacoemulsification will be done and endocyclophotocoagulation will be done after cataract extraction
phaco GSLProcedure or surgery
phacoemulsification will be done and then the angle is visualized by direct goniolens then the synechia are dissected by cohesive viscoelastic.
| Study group | Role | What they receive |
|---|---|---|
| A:phaco+MP-TSCPC | Experimental | 22 patients with primary angle closure glaucoma will undergo phacoemulsification and micropulse cyclophotocoagulation Receives: Procedure: phaco+MP-TSCPC |
| B:phaco+TSCPC | Experimental | 22 patients with primary angle closure glaucoma will undergo phaco and transscleral cyclophotocoagulation Receives: Procedure: phaco+TSCPC |
| C:phaco+endocyclophotocoagulation | Experimental | 22 patients with primary angle closure glaucoma will undergo phaco and endocyclophotocoagulation after cataract removal Receives: Procedure: phaco+endocyclophotocoagulation |
| D:phaco GSL | Experimental | 22 patients with primary angle closure glaucoma will undergo phaco and goniosynechiolysis Receives: Procedure: phaco GSL |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of intraocular pressure change
measuring the intraocular pressure after 1M, 3M and 6M
Measured: 6 Months
Secondary outcomes (1)
percent change of antiglaucoma medications
the number of medication before and after the procedure
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 Oct 2022
- Study start11 Aug 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angle Closure 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
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fayrouz Aboalazayem, Cairo University
- Investigators
- Ahmed Abdelrahman, PhD, Study chair, kasr alainy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576493
- Sponsor's protocol ID
- N-68-2022
- Status last verified
- Aug 2023
- First submitted
- 8 Oct 2022
- Last updated
- 30 Aug 2023
- Results posted
- 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 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Phacoemulsification and Different Modes of Diode Laser Therapy in Management of Chronic Angle Closure Glaucoma. A Comparative Study
- ClinicalTrials.gov ID
- NCT05576493
- Acronym / sponsor ID
- N-68-2022
- Conditions
- Angle Closure Glaucoma
- Keywords
- angle closure glaucoma, cyclophotocoagulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 12 Oct 2022 (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.
comparing different types of cuclophotocoagulation with cataract extraction to cataract extraction and goniocynechiolysis in cases of chronic angle closure glaucoma
Detailed description
Evaluation of the safety of MP-TSCPC , CW-TSCPC and endoscopic cyclophotocoagulation when combined with phacoemulsification in cases with CACG Comparing the efficacy of the combined procedures in control of the IOP and the success rate versus lens extraction combined with synechiolysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A:phaco+MP-TSCPC | Experimental | Procedure: phaco+MP-TSCPC22 patients with primary angle closure glaucoma will undergo phacoemulsification and micropulse cyclophotocoagulation |
| B:phaco+TSCPC | Experimental | Procedure: phaco+TSCPC22 patients with primary angle closure glaucoma will undergo phaco and transscleral cyclophotocoagulation |
| C:phaco+endocyclophotocoagulation | Experimental | Procedure: phaco+endocyclophotocoagulation22 patients with primary angle closure glaucoma will undergo phaco and endocyclophotocoagulation after cataract removal |
| D:phaco GSL | Experimental | Procedure: phaco GSL22 patients with primary angle closure glaucoma will undergo phaco and goniosynechiolysis |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between 20 to 70 years
- chronic angle closure glaucoma
Key exclusion criteria (2 listed)
- Patients in acute attack of angle closure.
- Patients with previous filtering surgery or cycloablative procedure
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 |
|---|---|---|
| phaco+MP-TSCPCThe procedure starts with performing the cyclophotocoagulation using the Micropulse P3 device (IQ 810 Laser Systems; Iridex, Mountain View, CA, USA) at 2500 mW with a duration of 90 seconds in each hemisphere at a 31.3% duty cycle under local anesthesia and then performing phacoemulsification and IOL implantation. | Procedure or surgery | A:phaco+MP-TSCPC |
| phaco+TSCPCThe procedure starts with performing the cyclophotocoagulation using the IRIDEX's G probe device (IRIDEX Corp. Mountain View, CA, USA) at 1500 to2000 mW with a duration of 1500 ms applying about 15 shots in one hemisphere only under local anesthesia and then performing phacoemulsification and IOL implantation. | Procedure or surgery | B:phaco+TSCPC |
| phaco+endocyclophotocoagulationphacoemulsification will be done and endocyclophotocoagulation will be done after cataract extraction | Procedure or surgery | C:phaco+endocyclophotocoagulation |
| phaco GSLphacoemulsification will be done and then the angle is visualized by direct goniolens then the synechia are dissected by cohesive viscoelastic. | Procedure or surgery | D:phaco GSL |
Primary outcome
the percentage of intraocular pressure change
Time frame: 6 Months
measuring the intraocular pressure after 1M, 3M and 6M
1 secondary outcome
percent change of antiglaucoma medications
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 30 Aug 2023.
- 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.
Ahmed Abdelrahman, PhD study chair
kasr alainy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phaco+MP-TSCPC, phaco+TSCPC and phaco+endocyclophotocoagulation in people with Angle Closure Glaucoma, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 2 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 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of intraocular pressure change (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 30 Aug 2023.