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Recruiting NCT06077253

Danish Angle Closure Prevention Trial

No phase Interventional Primary Angle Glaucoma Closure Suspect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Iridotomy.
Who it may be relevant to
Registry conditions: Primary Angle Glaucoma Closure Suspect. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Iridotomy
    Peripheral iridotomy (size \>200µm)

Primary outcome measures

  • Intraocular pressure [Time frame: 5 year]
  • Glaucoma [Time frame: 5 year]
  • Acute Primary Angle Closure [Time frame: 5 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Denmark · 5 centers
  • Aalborg University Hospital — Aalborg
  • Aarhus University Hospital — Aarhus
  • Rigshospitalet Glostrup — Glostrup Municipality
  • Odense University Hospital — Odense
  • Sygehus Lillebælt — Vejle

Identifiers

NCT: NCT06077253 · DAP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗