NCT04635020

Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 285 (estimated)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Exfoliation Glaucoma
• Cataract

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-10-01
• Primary completion: 2023-09-01
• Completion: 2033-09-01
• First posted: 2020-11-18
• Last updated: 2020-11-18

Locations

1 site across 1 country: Finland