Danish Angle Closure Prevention Trial (DAP)

October 4, 2023 updated by: University of Aarhus
To determine whether primary angle closure suspects (PACS) in a Caucasian population benefit from prophylactic laser iridotomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

242

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Niklas Telinius, PhD, DMSc
  • Phone Number: +4530238533
  • Email: telinius@me.com

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Not yet recruiting
        • Aalborg University Hospital
        • Contact:
          • Jan Simonsen
          • Phone Number: +4540562476
          • Email: jhs@rn.dk
      • Aarhus, Denmark, 8240
        • Recruiting
        • Aarhus University Hospital
        • Contact:
      • Glostrup, Denmark, 2600
        • Not yet recruiting
        • Rigshospitalet Glostrup
        • Contact:
      • Odense, Denmark, 5000
        • Not yet recruiting
        • Odense University Hospital
        • Contact:
      • Vejle, Denmark, 7100
        • Not yet recruiting
        • Sygehus Lillebælt
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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, glaucoma, uveitis, unstable retinal conditions, ocular malignancies, PEX, PDS, systemic or ocular corticosteroid treatment -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
One eye iridotomy, contralateral eye no intervention
Procedure: Iridotomy
Peripheral iridotomy (size >200µm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure
Time Frame: 5 year
GAT: ≥24mmHg or ≥22mmHg on two separate occasions
5 year
Glaucoma
Time Frame: 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.
5 year
Acute Primary Angle Closure
Time Frame: 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;
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Niklas Telinius, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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