Comparing iStent and laser treatment for exfoliation glaucoma during cataract surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of the iStent trabecular microbypass stent compared to selective laser trabeculoplasty (SLT) in patients with exfoliation glaucoma undergoing cataract surgery. Patients with stable or unstable glaucoma will be randomized into different treatment groups: one receiving cataract surgery with iStent, another with SLT, and a control group undergoing cataract surgery alone. The study aims to assess the outcomes of these interventions over a 12-month period. All participants will provide informed consent and undergo screening to determine their eligibility based on specific glaucoma criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Helsinki University Hospital
  Helsinki, Finland Recruiting

Study contacts

• Principal investigator: Mika Harju, MD, prof. — Helsinki University Central Hospital
• Study coordinator: Eeva Ojanen, MD
• Email: eeva.ojanen@hus.fi
• Phone: +358503608589

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.