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Compares two eye procedures for exfoliation glaucoma alongside cataract surgery

Compares iStent and laser treatment with cataract surgery in people with exfoliation glaucoma.

Plain-language title generated from the registry record
Registry title: Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group

Key facts

Where
Helsinki, FinlandSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 50 and 100 years old?

Source: NCT04635020, who can take part

Where in Finland

  • Helsinki University HospitalHelsinki, FinlandTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Helsinki University Central Hospital
Trial code
NCT04635020
Record updated
18 November 2020
Original description
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)Read full original descriptionShow less

A Prospective Randomised Trial Comparing Selective Laser Trabeculoplasty (SLT) and iStent Trabecular Micro-bypass Stent Implantation Combined With Cataract Surgery in Exfoliation Glaucoma

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)

Inclusion: Signed consent of information; Clinical significant cataract; Able to attend 12 month period; Mild to moderate exfoliation glaucoma according to European glaucoma society guidelines (EGS); Group I stable glaucoma (IOP within individual target IOP), and group II unstable glaucoma (IOP above individual target IOP) with baseline glaucoma medication; Target IOP ≥16; Able to understand Finnish, Swedish or English.

Exclusion: Baseline IOP prior to enrolment ≥30 mmHg, and ≥3 glaucoma medications; Unable to use topical medical therapy; Previous intraocular surgery, refractive surgery or cycloablation; Two or more prior SLT or laser trabeculoplasty; Clinically significant corneal dystrophy or other hindering corneal condition; Unable to participate due to another medical disease or condition; Active uveitis, cystic macular edema (CME), exudative age-related macular degeneration, proliferative diabetic retinopathy or clinical significant macular edema, intraocular neoplasm, intraocular injections, intraocular lens luxation, phacodonesis; Clinical set target IOP < 16 mmHg in advanced glaucoma; Closed angle; Congenital angle anomaly; Central corneal thickness of less than 480um or more than 620um; Participating in another clinical trial.

ClinicalTrials.gov NCT04635020