Back to resultsCombined Phacoemulsification and Diode Laser Therapy in Chronic Angle Closure Glaucoma
Primary Purpose
Angle Closure Glaucoma
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
phaco+MP-TSCPC
phaco+TSCPC
phaco+endocyclophotocoagulation
phaco GSL
Sponsored by
About this trial
This is an interventional treatment trial for Angle Closure Glaucoma focused on measuring angle closure glaucoma, cyclophotocoagulation
Eligibility Criteria
Inclusion Criteria:
- Patients between 20 to 70 years
chronic angle closure glaucoma
Exclusion Criteria:
- Patients in acute attack of angle closure.
- Patients with previous filtering surgery or cycloablative procedure
Sites / Locations
- Kasr Alainy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
A:phaco+MP-TSCPC
B:phaco+TSCPC
C:phaco+endocyclophotocoagulation
D:phaco GSL
Arm Description
22 patients with primary angle closure glaucoma will undergo phacoemulsification and micropulse cyclophotocoagulation
22 patients with primary angle closure glaucoma will undergo phaco and transscleral cyclophotocoagulation
22 patients with primary angle closure glaucoma will undergo phaco and endocyclophotocoagulation after cataract removal
22 patients with primary angle closure glaucoma will undergo phaco and goniosynechiolysis
Outcomes
Primary Outcome Measures
the percentage of intraocular pressure change
measuring the intraocular pressure after 1M, 3M and 6M
Secondary Outcome Measures
percent change of antiglaucoma medications
the number of medication before and after the procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05576493
Brief Title
Combined Phacoemulsification and Diode Laser Therapy in Chronic Angle Closure Glaucoma
Official Title
Combined Phacoemulsification and Different Modes of Diode Laser Therapy in Management of Chronic Angle Closure Glaucoma. A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angle Closure Glaucoma
Keywords
angle closure glaucoma, cyclophotocoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A:phaco+MP-TSCPC
Arm Type
Experimental
Arm Description
22 patients with primary angle closure glaucoma will undergo phacoemulsification and micropulse cyclophotocoagulation
Arm Title
B:phaco+TSCPC
Arm Type
Experimental
Arm Description
22 patients with primary angle closure glaucoma will undergo phaco and transscleral cyclophotocoagulation
Arm Title
C:phaco+endocyclophotocoagulation
Arm Type
Experimental
Arm Description
22 patients with primary angle closure glaucoma will undergo phaco and endocyclophotocoagulation after cataract removal
Arm Title
D:phaco GSL
Arm Type
Experimental
Arm Description
22 patients with primary angle closure glaucoma will undergo phaco and goniosynechiolysis
Intervention Type
Procedure
Intervention Name(s)
phaco+MP-TSCPC
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
phaco+TSCPC
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
phaco+endocyclophotocoagulation
Intervention Description
phacoemulsification will be done and endocyclophotocoagulation will be done after cataract extraction
Intervention Type
Procedure
Intervention Name(s)
phaco GSL
Intervention Description
phacoemulsification will be done and then the angle is visualized by direct goniolens then the synechia are dissected by cohesive viscoelastic.
Primary Outcome Measure Information:
Title
the percentage of intraocular pressure change
Description
measuring the intraocular pressure after 1M, 3M and 6M
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
percent change of antiglaucoma medications
Description
the number of medication before and after the procedure
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients between 20 to 70 years
chronic angle closure glaucoma
Exclusion Criteria:
Patients in acute attack of angle closure.
Patients with previous filtering surgery or cycloablative procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelrahman, PhD
Organizational Affiliation
kasr alainy
Official's Role
Study Chair
Facility Information:
Facility Name
Kasr Alainy
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combined Phacoemulsification and Diode Laser Therapy in Chronic Angle Closure Glaucoma
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