Danish Angle Closure Prevention Trial
DAP
1 other identifier
interventional
242
1 country
5
Brief Summary
To determine whether primary angle closure suspects (PACS) in a Caucasian population benefit from prophylactic laser iridotomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 4, 2023
CompletedFirst Posted
Study publicly available on registry
October 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
November 13, 2023
July 1, 2023
6 years
October 4, 2023
November 9, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Intraocular pressure
GAT: ≥24mmHg or ≥22mmHg on two separate occasions
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.
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;
5 year
Study Arms (1)
Arm 1
OTHEROne eye iridotomy, contralateral eye no intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pseudophakia
- Previous iridotomy
- Clinically significant cataract with indication for surgery,
- Gaucoma
- Uveitis
- Unstable retinal conditions
- Ocular malignancies
- PEX
- PDS
- Systemic or ocular corticosteroid treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Aalborg University Hospital
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus, 8240, Denmark
Rigshospitalet Glostrup
Glostrup Municipality, 2600, Denmark
Odense University Hospital
Odense, 5000, Denmark
Sygehus Lillebælt
Vejle, 7100, Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Niklas Telinius
Aarhus University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2023
First Posted
October 11, 2023
Study Start
September 1, 2023
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
September 1, 2029
Last Updated
November 13, 2023
Record last verified: 2023-07