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
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 100
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Contact Information
Primary
Eeva Ojanen, MD
eeva.ojanen@hus.fi
+358503608589
Time Frame
Start Date: 2020-10-01
Estimated Completion Date: 2033-09
Participants
Target number of participants: 285
Treatments
Experimental: Stable glaucoma iStent
Cataract surgery combined with iStent inject
Experimental: Stable glaucoma SLT-laser
Cataract surgery combined with SLT-laser 1 month after surgery
Active_comparator: Stable glaucoma
Cataract surgery
Experimental: Unstable glaucoma iStent
Cataract surgery combined with iStent inject
Experimental: Unstable glaucoma SLT-laser
Cataract surgery combined with SLT-laser 1 month after surgery
Related Therapeutic Areas
Sponsors
Leads: Helsinki University Central Hospital