Danish Angle Closure Prevention Trial

University of Aarhus242 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

242

Conditions

Primary Angle Glaucoma Closure Suspect

Interventions

IridotomyPROCEDURE

Peripheral iridotomy (size \>200µm)

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (5)

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Rigshospitalet Glostrup

Glostrup Municipality, Denmark

RECRUITING

Outcomes

Primary Outcomes

Intraocular pressure

GAT: ≥24mmHg or ≥22mmHg on two separate occasions

Time frame: 5 year

Glaucoma

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.

Time frame: 5 year

Acute Primary Angle Closure

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;

Time frame: 5 year

Central Contacts

Niklas Telinius, PhD, DMSc

CONTACT

+4530238533 telinius@me.com

Data from ClinicalTrials.gov

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