Phaco-ECP vs Phaco Alone in Primary Angle Closure (PHEPHA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Glaucoma, Angle-Closure
• Intervention / Treatment: Procedure: Phacoemulsification; Procedure: Endoscopic cyclophotocoagulation

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 Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muneera AlFutais; Phone Number: 1374 +966114849700; Email: mfutais@kkesh.med.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11462
    • Recruiting
    • King Khaled Eye Specialist Hospital
    • Contact: Muneera AlFutais; Phone Number: 1374 +966114849700; Email: mfutais@kkesh.med.sa
    • Principal Investigator: Adi Al Owaifeer, MBBS
    • Principal Investigator: Ibrahim Alobaida, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age is above 40 years old.
2. 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.
3. 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.
4. Patient is able to give an informed consent and tolerate a period of medication washout.

Exclusion Criteria:

1. Previous intraocular surgery (including CPC). Glaucoma laser procedures are allowed (e.g. LPI, iridoplasty, and laser trabeculoplasty).
2. Previous ocular trauma.
3. A central corneal thickness that does not lie between 500 and 600 microns.
4. A diagnosis of nanophthalmos (defined as an axial length that is less than 20 mm).
5. Presence of pseudoexfoliation.
6. Presence of secondary causes of angle closure such as neovascular glaucoma and uveitic glaucoma.
7. Presence of diabetic retinopathy (active PDR or active DME) or agerelated macular degeneration. PHEPHA Protocol Version 2 September 3, 2020
8. 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 2. 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).
9. Any ocular or systemic condition that is presumed to prevent reliable clinical examination and/or visual field testing.
10. Pregnancy.
11. Inability to attend postoperative follow ups for a period of 12 months after surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure (IOP)	Change in IOP between baseline (pre-intervention) and the last follow-up visit	12 months
Number of glaucoma medications	Change in the number of glaucoma medications between baseline (pre-intervention) and the last follow-up visit	12 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2020
• Primary Completion (Anticipated): February 15, 2022
• Study Completion (Anticipated): February 15, 2022

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Intraocular pressure; Glaucoma; Phacoemulsification; Laser; Endoscopic cyclophotocoagulation; Primary angle closure glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Angle-Closure
• Other Study ID Numbers: 1956-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No