Comparing deep sclerectomy and trabeculectomy for normal tension glaucoma
Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
This study is testing whether a new eye surgery called deep sclerectomy can lower eye pressure as well as the traditional surgery, trabeculectomy, in people with normal tension glaucoma who aren't doing well on medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 55 Years to 100 Years |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 1 site (Helsinki) |
| Trial ID | NCT05371977 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of deep sclerectomy compared to trabeculectomy in lowering intraocular pressure in patients with normal tension glaucoma. Participants with unstable glaucoma despite medication will be randomly assigned to receive either surgical intervention. The study will assess the outcomes based on intraocular pressure reduction and overall patient health. The goal is to determine if deep sclerectomy can serve as a viable alternative to the more traditional trabeculectomy.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with normal tension glaucoma who have unstable conditions despite current medication.
Not a fit: Patients with secondary glaucoma or those who have undergone previous glaucoma surgeries are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with an effective surgical option that may lead to better management of normal tension glaucoma.
How similar studies have performed: While there have been studies on trabeculectomy, the comparison with deep sclerectomy in this specific context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed Informed Consent * Normal Tension Glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (OCT) and possible equivalent visual field defects, IOP never more than 21 mmHg, and open anterior chamber angle * Glaucoma unstable with current medication assessed by a glaucoma specialist Exclusion Criteria: * Secondary Glaucoma e.g. due to previous injury or uveitis * Exfoliation syndrome * Pigment dispersion syndrome * Previous transscleral or endoscopic cyclophotocoagulation * Previous other glaucoma surgery * Previous retinal detachment * Previous intraocular surgery like vitrectomy and other retinal surgery * Wet age-related macular degeneration * Diabetic retonopathy * Previous corneal transplant or previous refractive surgery * Fuchs' dystrophy and other abnormalities compromising corneal clarity like scars * The patient does not want to participate in the study * The patient does not speak Finnish, Swedish or English * Dementia * Only eye with vision worse than 20/200 or loss of central visual field
Where this trial is running
Helsinki
- Helsinki University Central Hospital — Helsinki, Finland (Recruiting)
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.