NCT05576493

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

October 8, 2022

Last Update Submit

August 29, 2023

Conditions

Keywords

angle closure glaucomacyclophotocoagulation

Outcome Measures

Primary Outcomes (1)

  • the percentage of intraocular pressure change

    measuring the intraocular pressure after 1M, 3M and 6M

    6 Months

Secondary Outcomes (1)

  • percent change of antiglaucoma medications

    6 Months

Study Arms (4)

A:phaco+MP-TSCPC

EXPERIMENTAL

22 patients with primary angle closure glaucoma will undergo phacoemulsification and micropulse cyclophotocoagulation

Procedure: phaco+MP-TSCPC

B:phaco+TSCPC

EXPERIMENTAL

22 patients with primary angle closure glaucoma will undergo phaco and transscleral cyclophotocoagulation

Procedure: phaco+TSCPC

C:phaco+endocyclophotocoagulation

EXPERIMENTAL

22 patients with primary angle closure glaucoma will undergo phaco and endocyclophotocoagulation after cataract removal

Procedure: phaco+endocyclophotocoagulation

D:phaco GSL

EXPERIMENTAL

22 patients with primary angle closure glaucoma will undergo phaco and goniosynechiolysis

Procedure: phaco GSL

Interventions

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.

A:phaco+MP-TSCPC
phaco+TSCPCPROCEDURE

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.

B:phaco+TSCPC

phacoemulsification will be done and endocyclophotocoagulation will be done after cataract extraction

C:phaco+endocyclophotocoagulation
phaco GSLPROCEDURE

phacoemulsification will be done and then the angle is visualized by direct goniolens then the synechia are dissected by cohesive viscoelastic.

D:phaco GSL

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 20 to 70 years
  • chronic angle closure glaucoma

You may not qualify if:

  • Patients in acute attack of angle closure.
  • Patients with previous filtering surgery or cycloablative procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Ahmed Abdelrahman, PhD

    kasr alainy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

October 8, 2022

First Posted

October 12, 2022

Study Start

August 11, 2022

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations