Phaco-ECP vs Phaco Alone in Primary Angle Closure

Last updated: September 18, 2020
Sponsor: King Khaled Eye Specialist Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Treatment

N/A

Clinical Study ID

NCT04562402
1956-P
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age is above 40 years old.

  2. A diagnosis of either PAC or PACG. PAC will be defined as the presence ofirido-trabecular contact on gonioscopy, either appositional or in the presence ofperipheral anterior synechiae (PAS), without indentation (or prior documentationbefore a LPI has been performed) without any evidence of glaucomatous opticneuropathy. PACG will be defined as PAC along with an evidence of glaucomatous opticneuropathy. An optic neuropathy secondary to glaucoma will be defined as evidence ofstructural and functional damage suggestive of glaucoma as demonstrated by clinicalexamination, optical coherence tomography, and visual field testing.

  3. IOP measurement that is more than 21 mmHg (not exceeding 35 mmHg) without the use ofglaucoma medications or less than 21 mmHg with medications.

  4. Patient is able to give an informed consent and tolerate a period of medicationwashout.

Exclusion

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 uveiticglaucoma.

  7. Presence of diabetic retinopathy (active PDR or active DME) or agerelated maculardegeneration. PHEPHA Protocol Version 2 September 3, 2020

  8. Advanced glaucoma as defined by the Glaucoma Severity Staging System12 (mean deviationworse 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% leveland greater than or equal to 25% but fewer than 50% of points depressed below 1% level

  9. Any point within central 5 degrees with sensitivity < 0db 3. Both hemifieldscontaining a point(s) with sensitivity < 15 dB within 5 degrees of fixation).

  10. Any ocular or systemic condition that is presumed to prevent reliable clinicalexamination and/or visual field testing.

  11. Pregnancy.

  12. Inability to attend postoperative follow ups for a period of 12 months after surgery.

Study Design

Total Participants: 104
Study Start date:
August 16, 2020
Estimated Completion Date:
February 15, 2022

Study 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.

Connect with a study center

  • King Khaled Eye Specialist Hospital

    Riyadh, 11462
    Saudi Arabia

    Active - Recruiting

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