Combined Phacoemulsification and Diode Laser Therapy in Chronic Angle Closure Glaucoma

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05576493

Collaborator

(none)

Enrollment

Location

Arms

8.6

Anticipated Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

comparing different types of cuclophotocoagulation with cataract extraction to cataract extraction and goniocynechiolysis in cases of chronic angle closure glaucoma

Condition or Disease	Intervention/Treatment	Phase
Angle Closure Glaucoma	Procedure: phaco+MP-TSCPC Procedure: phaco+TSCPC Procedure: phaco+endocyclophotocoagulation Procedure: phaco GSL	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Combined Phacoemulsification and Different Modes of Diode Laser Therapy in Management of Chronic Angle Closure Glaucoma. A Comparative Study

Actual Study Start Date :

Aug 11, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A:phaco+MP-TSCPC 22 patients with primary angle closure glaucoma will undergo phacoemulsification and micropulse cyclophotocoagulation	Procedure: phaco+MP-TSCPC 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.
Experimental: B:phaco+TSCPC 22 patients with primary angle closure glaucoma will undergo phaco and transscleral cyclophotocoagulation	Procedure: phaco+TSCPC 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.
Experimental: C:phaco+endocyclophotocoagulation 22 patients with primary angle closure glaucoma will undergo phaco and endocyclophotocoagulation after cataract removal	Procedure: phaco+endocyclophotocoagulation phacoemulsification will be done and endocyclophotocoagulation will be done after cataract extraction
Experimental: D:phaco GSL 22 patients with primary angle closure glaucoma will undergo phaco and goniosynechiolysis	Procedure: phaco GSL phacoemulsification will be done and then the angle is visualized by direct goniolens then the synechia are dissected by cohesive viscoelastic.

Outcome Measures

Primary Outcome Measures

the percentage of intraocular pressure change [6 Months]
measuring the intraocular pressure after 1M, 3M and 6M

Secondary Outcome Measures

percent change of antiglaucoma medications [6 Months]
the number of medication before and after the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Alainy	Cairo		Egypt	11562

Sponsors and Collaborators

Cairo University

Investigators

Study Chair: Ahmed Abdelrahman, PhD, kasr alainy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fayrouz Aboalazayem, lecturer, Cairo University

ClinicalTrials.gov Identifier:

NCT05576493

Other Study ID Numbers:

N-68-2022

First Posted:

Oct 12, 2022

Last Update Posted:

Oct 13, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fayrouz Aboalazayem, lecturer, Cairo University

angle closure glaucoma

cyclophotocoagulation

Additional relevant MeSH terms:

Glaucoma

Glaucoma, Angle-Closure

Study Results

No Results Posted as of Oct 13, 2022