Comparing iStent and laser treatment for exfoliation glaucoma during cataract surgery
A Prospective Randomised Trial Comparing Selective Laser Trabeculoplasty (SLT) and iStent Trabecular Micro-bypass Stent Implantation Combined With Cataract Surgery in Exfoliation Glaucoma
This study is testing whether using the iStent or laser treatment during cataract surgery helps people with exfoliation glaucoma see better compared to just having cataract surgery alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 285 (estimated) |
| Ages | 50 Years to 100 Years |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 1 site (Helsinki) |
| Trial ID | NCT04635020 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with mild to moderate exfoliation glaucoma and significant cataracts who can attend follow-up visits for 12 months.
Not a fit: Patients with advanced glaucoma or those unable to use topical medical therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with exfoliation glaucoma undergoing cataract surgery.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Helsinki
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.