Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group

Launched by HELSINKI UNIVERSITY CENTRAL HOSPITAL · Nov 17, 2020

Keywords

ClinConnect Summary

The Helsinki Study Group is conducting a clinical trial to compare two treatments for patients with exfoliation glaucoma who also need cataract surgery. The study is looking at the effectiveness of a small device called an iStent, which is designed to improve fluid drainage in the eye, versus a laser treatment known as selective laser trabeculoplasty. Both treatments will be combined with cataract surgery, and the goal is to find out which method works better in managing eye pressure for people with this condition.

To participate in the trial, individuals must be between the ages of 18 and 35 and have significant cataracts along with mild to moderate exfoliation glaucoma. Participants will need to attend follow-up visits for a year and must be able to understand Finnish, Swedish, or English. The study is currently recruiting, and it's important to note that certain medical conditions or previous eye surgeries may make someone ineligible. If you join the trial, you can expect to receive either the iStent or laser treatment during your cataract surgery, with regular check-ups to monitor your eye health and pressure levels over the course of the study.

Gender

ALL

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