Iridotomy
ProcedurePeripheral iridotomy (size >200µm)
Recruiting
NCT Number: NCT06077253
Danish Angle Closure Prevention Trial
To determine whether primary angle closure suspects (PACS) in a Caucasian population benefit from prophylactic laser iridotomy.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
40 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Aalborg University Hospital, Aalborg, Denmark
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About this study
Prospective, randomised paired-eye design clinical trial comparing peripheral laser iridotomy in one eye with observation in the other over 5-years follow-up.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Intraocular pressure
Time frame: 5 year
GAT: ≥24mmHg or ≥22mmHg on two separate occasions
-
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.
-
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;
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Aarhus
Other
Registry information
Acronym: DAP
Important dates
- Study start
- 2023
- Primary completion
- 2029
- Study completion
- 2029
- First posted
- Oct 11, 2023
- Registry last updated
- Nov 13, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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