search
Back to results

Danish Angle Closure Prevention Trial (DAP)

Primary Purpose

Primary Angle Glaucoma Closure Suspect

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Iridotomy
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Primary Angle Glaucoma Closure Suspect

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Aalborg University Hospital
  • Aarhus University HospitalRecruiting
  • Rigshospitalet Glostrup
  • Odense University Hospital
  • Sygehus Lillebælt

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

One eye iridotomy, contralateral eye no intervention

Outcomes

Primary Outcome Measures

Intraocular pressure
GAT: ≥24mmHg or ≥22mmHg on two separate occasions
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.
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;

Secondary Outcome Measures

Full Information

First Posted
October 4, 2023
Last Updated
October 4, 2023
Sponsor
University of Aarhus
search

1. Study Identification

Unique Protocol Identification Number
NCT06077253
Brief Title
Danish Angle Closure Prevention Trial
Acronym
DAP
Official Title
Danish Angle Closure Prevention Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 1, 2029 (Anticipated)
Study Completion Date
September 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Angle Glaucoma Closure Suspect

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One eye intervention (prophylactic iridotomy), one eye no intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
One eye iridotomy, contralateral eye no intervention
Intervention Type
Procedure
Intervention Name(s)
Iridotomy
Intervention Description
Peripheral iridotomy (size >200µm)
Primary Outcome Measure Information:
Title
Intraocular pressure
Description
GAT: ≥24mmHg or ≥22mmHg on two separate occasions
Time Frame
5 year
Title
Glaucoma
Description
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.
Time Frame
5 year
Title
Acute Primary Angle Closure
Description
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;
Time Frame
5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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, glaucoma, uveitis, unstable retinal conditions, ocular malignancies, PEX, PDS, systemic or ocular corticosteroid treatment -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niklas Telinius, PhD, DMSc
Phone
+4530238533
Email
telinius@me.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niklas Telinius
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Simonsen
Phone
+4540562476
Email
jhs@rn.dk
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8240
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niklas Telinius
Phone
+4530238533
Email
telinius@me.com
Facility Name
Rigshospitalet Glostrup
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Kolko
Phone
+4529807667
Email
miriam.kolko@regionh.dk
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Ruhlmann
Phone
+4542397363
Email
ruhlmann@dadlnet.dk
Facility Name
Sygehus Lillebælt
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Torp
Phone
+457940 6458
Email
Thomas.Lee.Torp@rsyd.dk

12. IPD Sharing Statement

Learn more about this trial

Danish Angle Closure Prevention Trial

We'll reach out to this number within 24 hrs