Danish Angle Closure Prevention Trial

Not Applicable

Recruiting

• Conditions: Primary Angle Glaucoma Closure Suspect
• Interventions: Procedure: Iridotomy

• Registration Number: NCT06077253
• Lead Sponsor: University of Aarhus

Brief Summary

To determine whether primary angle closure suspects (PACS) in a Caucasian population benefit from prophylactic laser iridotomy.

Detailed Description

Prospective, randomised paired-eye design clinical trial comparing peripheral laser iridotomy in one eye with observation in the other over 5-years follow-up.

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-09-01
• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13
• Primary Completion: 2029-09-01
• Study Completion: 2029-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• Primary angle closure suspect: ≥180 degrees (cumulative) irido-trabecular contact on darkroom gonioscopy, IOP<21mmHg, no peripheral anterior synechiae, no glaucomatous optic neuropathy
• Best-corrected visual acuity (BCVA) >0.8 on both eyes
• Caucasian

Exclusion Criteria

• Pseudophakia
• Previous iridotomy
• Clinically significant cataract with indication for surgery,
• Gaucoma
• Uveitis
• Unstable retinal conditions
• Ocular malignancies
• PEX
• PDS
• Systemic or ocular corticosteroid treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Iridotomy	One eye iridotomy, contralateral eye no intervention

Primary Outcome Measures

Name	Time	Method
Glaucoma	5 year	The presence of glaucomatous optic neuropathy with visual field loss compatible with glaucoma. Glaucomatous optic neuropathy defined as loss of neuroretinal rim (notch or erosion), a vertical cup-to-disc ratio of more than 0.7, nerve fiber layer defect attributable to glaucoma, or both.
Acute Primary Angle Closure	5 year	Presence of at least 2 of the following symptoms: ocular or periocular pain; nausea, vomiting, or both; an antecedent history of intermittent blurring of vision with haloes and IOP of more than 30 mmHg and presence of at least 3 of the following signs: conjunctival injection, corneal epithelial edema, mid-dilated unreactive pupil, glaukomflecken, and shallow anterior chamber;
Intraocular pressure	5 year	GAT: ≥24mmHg or ≥22mmHg on two separate occasions

Trial Locations

Locations (5)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Rigshospitalet Glostrup; 🇩🇰 Glostrup, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Sygehus Lillebælt; 🇩🇰 Vejle, Denmark