Actively Recruiting

Phase Not Applicable
Age: 50Years - 100Years
All Genders
NCT04635020

Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group

Led by Helsinki University Central Hospital · Updated on 2020-11-18

285

Participants Needed

1

Research Sites

674 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of the study is to investigate the efficacy of an iStent trabecular microbypass stent compared to selective laser trabeculoplasty in combination with cataract surgery in eyes with exfoliation glaucoma (EXF)

CONDITIONS

Official Title

Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group

Who Can Participate

Age: 50Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed consent of information
  • Presence of clinically significant cataract
  • Ability to attend all visits during a 12-month period
  • Diagnosis of mild to moderate exfoliation glaucoma according to European glaucoma society guidelines
  • Stable glaucoma with intraocular pressure (IOP) within individual target IOP or unstable glaucoma with IOP above target with baseline glaucoma medication
  • Target intraocular pressure of 16 mmHg or higher
  • Ability to understand Finnish, Swedish, or English
Not Eligible

You will not qualify if you...

  • Target intraocular pressure less than 16 mmHg in advanced glaucoma
  • Baseline intraocular pressure prior to enrollment of 30 mmHg or higher and use of 3 or more glaucoma medications
  • Closed angle or congenital angle anomaly
  • Clinically significant corneal dystrophy or other corneal conditions that hinder treatment
  • Inability to use topical medical therapy
  • Central corneal thickness less than 480 micrometers or more than 620 micrometers
  • Active uveitis, cystic macular edema, exudative age-related macular degeneration, proliferative diabetic retinopathy, significant macular edema, intraocular neoplasm, intraocular injections, intraocular lens luxation, or phacodonesis
  • Previous intraocular surgery, refractive surgery, or cycloablation
  • Two or more prior selective laser trabeculoplasty or laser trabeculoplasty treatments
  • Inability to participate due to other medical diseases or conditions
  • Participation in another clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Helsinki University Hospital

Helsinki, Finland

Actively Recruiting

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Research Team

E

Eeva Ojanen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group | DecenTrialz