NCT06077253

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
40mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

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 Progress45%
Sep 2023Sep 2029

Study Start

First participant enrolled

September 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

November 13, 2023

Status Verified

July 1, 2023

Enrollment Period

6 years

First QC Date

October 4, 2023

Last Update Submit

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

OTHER

One eye iridotomy, contralateral eye no intervention

Procedure: Iridotomy

Interventions

IridotomyPROCEDURE

Peripheral iridotomy (size \>200µm)

Arm 1

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Aarhus University Hospital

Aarhus, 8240, Denmark

RECRUITING

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

NOT YET RECRUITING

Sygehus Lillebælt

Vejle, 7100, Denmark

RECRUITING

Study Officials

  • Niklas Telinius

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niklas Telinius, PhD, DMSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: One eye intervention (prophylactic iridotomy), one eye no intervention
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

Locations