Phaco-ECP vs Phaco Alone in Primary Angle Closure

Glaucoma, Angle-Closure Clinical Trial

— PHEPHA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04562402
• Other study ID #: 1956-P
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2020
• Est. completion date: February 15, 2022

Study information

• Verified date: September 2020
• Source: King Khaled Eye Specialist Hospital
• Contact: Muneera AlFutais
• Phone: +966114849700
• Email: mfutais[@]kkesh.med.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Angle-Closure

Intervention

Procedure:
• Phacoemulsification
cataract surgery via phacoemulsification
• Endoscopic cyclophotocoagulation
Endoscopic ablation of the ciliary body

Locations

Country	Name	City	State
Saudi Arabia	King Khaled Eye Specialist Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Khaled Eye Specialist Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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