Combined Phacoemulsification and Diode Laser Therapy in Chronic Angle Closure Glaucoma

August 29, 2023 updated by: Fayrouz Aboalazayem, Cairo University

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Kasr Alainy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the percentage of intraocular pressure change
Time Frame: 6 Months
measuring the intraocular pressure after 1M, 3M and 6M
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percent change of antiglaucoma medications
Time Frame: 6 Months
the number of medication before and after the procedure
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Ahmed Abdelrahman, PhD, Kasr Alainy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2022

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

October 8, 2022

First Submitted That Met QC Criteria

October 8, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-68-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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