NCT04635020Recruiting
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
Source: ClinicalTrials.gov · Last updated 18 Nov 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 285 (estimated)
- First submitted
- 29 Oct 2020
- Start date
- 1 Oct 2020
- Primary completion date
- Sept 2023
- Lead sponsor
- Helsinki University Central Hospital
- Diseases
- Glaucoma
- NCT number
- NCT04635020
What you commit to
- Study type: Interventional
- Planned participants: 285
- From 1 Oct 2020 to the primary completion date, Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Baseline IOP prior to enrolment ≥30 mmHg, and ≥3 glaucoma medications
- Unable to use topical medical therapy
- Previous intraocular surgery, refractive surgery or cycloablation
- Two or more prior SLT or laser trabeculoplasty
Other illness
- Clinically significant corneal dystrophy or other hindering corneal condition
- Unable to participate due to another medical disease or condition
Age
- 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.
Other
- Clinical set target IOP \< 16 mmHg in advanced glaucoma
- Closed angle
- Congenital angle anomaly
- Central corneal thickness of less than 480um or more than 620um
- Participating in another clinical trial
Who the study is looking for
- 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
Age in the registry: 50 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.