PHEPHA: Phaco-ECP vs Phaco Alone in Primary Angle Closure

Sponsor

King Khaled Eye Specialist Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04562402

Collaborator

(none)

104

Enrollment

Location

Arms

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison between phacoemulsification with endoscopic cyclophotocoagulation versus phacoemulsification alone in patients with either primary angle closure or primary angle closure glaucoma presenting with cataract or a clear lens.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Angle-Closure	Procedure: Phacoemulsification Procedure: Endoscopic cyclophotocoagulation	N/A

Detailed Description

The purpose of our current randomized clinical trial is to compare phacoemulsification with endoscopic cyclophotocoagulation (PHE) versus phacoemulsification alone (PHA) in patients with either primary angle closure (PAC) or primary angle closure glaucoma (PACG) presenting with cataract or a clear lens.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Phacoemulsification With Endoscopic Cyclophotocoagulation vs Phacoemulsification Alone in Primary Angle Closure (PHEPHA): A Randomized Clinical Trial

Actual Study Start Date :

Aug 16, 2020

Anticipated Primary Completion Date :

Feb 15, 2022

Anticipated Study Completion Date :

Feb 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Phacoemulsification with endoscopic cyclophotocoagulation Cataract extraction via phacoemulsification along with endoscopic cyclophotocoagulation of the ciliary body.	Procedure: Phacoemulsification cataract surgery via phacoemulsification Procedure: Endoscopic cyclophotocoagulation Endoscopic ablation of the ciliary body
Active Comparator: Phacoemulsification alone Cataract extraction via phacoemulsification.	Procedure: Phacoemulsification cataract surgery via phacoemulsification

Arm

Intervention/Treatment

Active Comparator: Phacoemulsification with endoscopic cyclophotocoagulation

Cataract extraction via phacoemulsification along with endoscopic cyclophotocoagulation of the ciliary body.

Procedure: Phacoemulsification

cataract surgery via phacoemulsification

Procedure: Endoscopic cyclophotocoagulation

Endoscopic ablation of the ciliary body

Active Comparator: Phacoemulsification alone

Cataract extraction via phacoemulsification.

Procedure: Phacoemulsification

cataract surgery via phacoemulsification

Outcome Measures

Primary Outcome Measures

Intraocular Pressure (IOP) [12 months]
Change in IOP between baseline (pre-intervention) and the last follow-up visit
Number of glaucoma medications [12 months]
Change in the number of glaucoma medications between baseline (pre-intervention) and the last follow-up visit

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age is above 40 years old.
A diagnosis of either PAC or PACG. PAC will be defined as the presence of irido-trabecular contact on gonioscopy, either appositional or in the presence of peripheral anterior synechiae (PAS), without indentation (or prior documentation before a LPI has been performed) without any evidence of glaucomatous optic neuropathy. PACG will be defined as PAC along with an evidence of glaucomatous optic neuropathy. An optic neuropathy secondary to glaucoma will be defined as evidence of structural and functional damage suggestive of glaucoma as demonstrated by clinical examination, optical coherence tomography, and visual field testing.
IOP measurement that is more than 21 mmHg (not exceeding 35 mmHg) without the use of glaucoma medications or less than 21 mmHg with medications.
Patient is able to give an informed consent and tolerate a period of medication washout.

Exclusion Criteria:

Previous intraocular surgery (including CPC). Glaucoma laser procedures are allowed (e.g. LPI, iridoplasty, and laser trabeculoplasty).
Previous ocular trauma.
A central corneal thickness that does not lie between 500 and 600 microns.
A diagnosis of nanophthalmos (defined as an axial length that is less than 20 mm).
Presence of pseudoexfoliation.
Presence of secondary causes of angle closure such as neovascular glaucoma and uveitic glaucoma.
Presence of diabetic retinopathy (active PDR or active DME) or agerelated macular degeneration. PHEPHA Protocol Version 2 September 3, 2020
Advanced glaucoma as defined by the Glaucoma Severity Staging System12 (mean deviation worse than -12.01 dB and at least one of the following: 1. On pattern deviation plot, greater than or equal to 50% but fewer than 75% of points depressed below the 5% level and greater than or equal to 25% but fewer than 50% of points depressed below 1% level
Any point within central 5 degrees with sensitivity < 0db 3. Both hemifields containing a point(s) with sensitivity < 15 dB within 5 degrees of fixation).
Any ocular or systemic condition that is presumed to prevent reliable clinical examination and/or visual field testing.
Pregnancy.
Inability to attend postoperative follow ups for a period of 12 months after surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King Khaled Eye Specialist Hospital	Riyadh		Saudi Arabia	11462

Sponsors and Collaborators

King Khaled Eye Specialist Hospital

Investigators

Principal Investigator: Adi Al Owaifeer, MBBS, King Khaled Eye Specialist Hospital
Principal Investigator: Ibrahim Alobaida, MD, King Khaled Eye Specialist Hospital