Danish Angle Closure Prevention Trial

Primary Angle Glaucoma Closure Suspect Clinical Trial

— DAP  

Official title:

Danish Angle Closure Prevention Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077253
• Other study ID #: DAP
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 1, 2029

Study information

• Verified date: July 2023
• Source: University of Aarhus
• Contact: Niklas Telinius, PhD, DMSc
• Phone: +4530238533
• Email: telinius[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: September 1, 2029
• Est. primary completion date: September 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Primary Angle Glaucoma Closure Suspect

Intervention

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

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet Glostrup	Glostrup
Denmark	Odense University Hospital	Odense
Denmark	Sygehus Lillebælt	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure	GAT: =24mmHg or =22mmHg on two separate occasions	5 year
Primary	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
Primary	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