Phaco-ECP vs Phaco Alone in Primary Angle Closure

NCT04562402 | Unknown DMC

• 1 other identifier: 1956-P
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma, Angle-Closure

Keywords

Glaucoma; Endoscopic cyclophotocoagulation; Laser; Intraocular pressure; Phacoemulsification; Primary angle closure glaucoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Phacoemulsification with endoscopic cyclophotocoagulation

ACTIVE COMPARATOR

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

Procedure: Phacoemulsification; Procedure: Endoscopic cyclophotocoagulation

Phacoemulsification alone

ACTIVE COMPARATOR

Cataract extraction via phacoemulsification.

Procedure: Phacoemulsification

Interventions

Phacoemulsification PROCEDURE

cataract surgery via phacoemulsification

Phacoemulsification alone; Phacoemulsification with endoscopic cyclophotocoagulation

Endoscopic cyclophotocoagulation PROCEDURE

Endoscopic ablation of the ciliary body

Phacoemulsification with endoscopic cyclophotocoagulation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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).
• 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.

Sponsors & Collaborators

• King Khaled Eye Specialist Hospital: lead

Study Sites (1)

King Khaled Eye Specialist Hospital

Riyadh, 11462, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Glaucoma, Angle-Closure; Glaucoma

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Adi Al Owaifeer, MBBS

  King Khaled Eye Specialist Hospital

  PRINCIPAL INVESTIGATOR

• Ibrahim Alobaida, MD

  King Khaled Eye Specialist Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muneera AlFutais

CONTACT

+966114849700; mfutais@kkesh.med.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: August 16, 2020
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: September 24, 2020

Record last verified: 2020-09

Locations

SA (1)