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Recruiting NCT04635020

Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group

No phase Interventional Exfoliation Glaucoma Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iStent, SLT-laser, Cataract surgery.
Who it may be relevant to
Registry conditions: Exfoliation Glaucoma, Cataract. Basic parameters: 50 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

Detailed description

Exfoliation glaucoma patients with significant cataracts are being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patient´s glaucoma is classified into stable or unstable glaucoma groups with their current glaucoma medication. Patients meeting the eligibility requirements of stable glaucoma will be randomised to cataract surgery combined with iStent (65 patients), II SLT (65 patients) or III cataract surgery alone (25 patients) and patient with unstable glaucoma will be randomised to cataract surgery combined with I iStent (65 patients), II SLT (65 patients).

Interventions

  • Procedure iStent
    2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork
  • Procedure SLT-laser
    1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees)
  • Procedure Cataract surgery
    Conventional cataract surgery

Primary outcome measures

  • Group I: Change in the number of IOP lowering medications compared to baseline [Time frame: 12 months]
  • Group II: Change in the IOP compared to baseline [Time frame: 12 months]
Secondary outcome measures (2)
  • Group I: Change in the IOP compared to baseline [Time frame: 12 months]
  • Group II: Change in the number of IOP lowering medications compared to baseline [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • Clinical set target IOP < 16 mmHg in advanced glaucoma
  • Baseline IOP prior to enrolment ≥30 mmHg, and ≥3 glaucoma medications
  • Closed angle
  • Congenital angle anomaly
  • Clinically significant corneal dystrophy or other hindering corneal condition
  • Unable to use topical medical therapy
  • Central corneal thickness of less than 480um or more than 620um
  • 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.
  • Previous intraocular surgery, refractive surgery or cycloablation
  • Two or more prior SLT or laser trabeculoplasty
  • Unable to participate due to another medical disease or condition
  • Participating in another clinical trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Finland · 1 center
  • Helsinki University Hospital — Helsinki

Identifiers

NCT: NCT04635020 · 123123

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗