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Studies

Interventional Recruiting

NCT06077253 on ClinicalTrials.gov

Danish Angle Closure Prevention Trial

  • Sponsor: Aarhus University
  • Enrollment: 242 (Estimated)
  • Study start: 2023-09-01 (Actual)
  • Primary completion: 2029-09-01 (Estimated)
  • Study completion: 2029-09-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Single Group
  • InterventionModelDescription: One eye intervention (prophylactic iridotomy), one eye no intervention
  • Masking: None
  • PrimaryPurpose: Prevention

Brief Summary

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

Conditions

  • Primary Angle Glaucoma Closure Suspect

Intervention / Treatment

  • Procedure: Iridotomy

Primary Outcome Measures

  • Intraocular pressure (5 year)
    GAT: ≥24mmHg or ≥22mmHg on two separate occasions
  • Glaucoma (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 (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;

Countries

Denmark

Locations and Investigators

  • Aalborg University Hospital, Aalborg, Denmark (Recruiting)
    • Jan Simonsen
  • Aarhus University Hospital, Aarhus, Denmark (Recruiting)
    • Niklas Telinius
  • Rigshospitalet Glostrup, Glostrup, Denmark (Recruiting)
  • Odense University Hospital, Odense, Denmark (Not yet recruiting)
    • Peter Ruhlmann
  • Sygehus Lillebælt, Vejle, Denmark (Recruiting)
    • Thomas Torp

Study Officials