Primary Angle Glaucoma Closure SuspectDAPNCT06077253
Danish Angle Closure Prevention Trial
A study testing Iridotomy in people with Primary Angle Glaucoma Closure Suspect, run by University of Aarhus at 5 sites in Denmark.
Trial summary
To determine whether primary angle closure suspects (PACS) in a Caucasian population benefit from prophylactic laser iridotomy. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Primary Angle Glaucoma Closure Suspect
- What is being tested?
- Iridotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 5 sitesDenmark
- Study dates
- 1 Sep 2023to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pseudophakia
- Previous iridotomy
- Clinically significant cataract with indication for surgery,
- Gaucoma
- Uveitis
- Unstable retinal conditions
Show all 10Show fewer
- Ocular malignancies
- PEX
- PDS
- Systemic or ocular corticosteroid treatment
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Jan Simonsen, +4540562476, jhs@rn.dk
- Recruiting
Aarhus University Hospital
Aarhus, 8240
Niklas Telinius, +4530238533, telinius@me.com
- Recruiting
Rigshospitalet Glostrup
Glostrup Municipality, 2600
Miriam Kolko, +4529807667, miriam.kolko@regionh.dk
- Not yet recruiting
Odense University Hospital
Odense, 5000
Peter Ruhlmann, +4542397363, ruhlmann@dadlnet.dk
- Recruiting
Sygehus Lillebælt
Vejle, 7100
Thomas Torp, +457940 6458, Thomas.Lee.Torp@rsyd.dk
About this study
To determine whether primary angle closure suspects (PACS) in a Caucasian population benefit from prophylactic laser iridotomy.
Read the 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.
- Conditions
- Primary Angle Glaucoma Closure Suspect
- Being tested
- Iridotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IridotomyProcedure or surgery
Peripheral iridotomy (size >200µm)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | One eye iridotomy, contralateral eye no intervention Receives: Procedure: Iridotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
GAT: ≥24mmHg or ≥22mmHg on two separate occasions
Measured: 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.
Measured: 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;
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Angle Glaucoma Closure SuspectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- One eye intervention (prophylactic iridotomy), one eye no intervention
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niklas Telinius, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077253
- Sponsor's protocol ID
- DAP
- Acronym
- DAP
- Status last verified
- Jul 2023
- First submitted
- 4 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Angle Closure Prevention Trial
- ClinicalTrials.gov ID
- NCT06077253
- Acronym / sponsor ID
- DAP / DAP
- Conditions
- Primary Angle Glaucoma Closure Suspect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One eye intervention (prophylactic iridotomy), one eye no intervention
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: IridotomyOne eye iridotomy, contralateral eye no intervention |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- Pseudophakia
- Previous iridotomy
- Clinically significant cataract with indication for surgery,
- Gaucoma
- Uveitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IridotomyPeripheral iridotomy (size >200µm) | Procedure or surgery | Arm 1 |
Primary outcome
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;
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Niklas Telinius principal investigator
Aarhus University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iridotomy in people with Primary Angle Glaucoma Closure Suspect, run by University of Aarhus at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niklas Telinius, PhD, DMSc (+4530238533, telinius@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: 5 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023; AzTrials last refreshed its copy on 27 Oct 2026.