Comparing deep sclerectomy and trabeculectomy for normal tension glaucoma
Official title: Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
Run by Helsinki University Central Hospital · NCT05371977 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 55 Years to 100 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 1 site (Helsinki) |
| Status | Recruiting |
| Started | May 31, 2022 |
| Main results expected | May 2026 |
| Study ends | May 2029 |
| Registry record updated | March 15, 2024 |
| Trial ID | NCT05371977 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with normal tension glaucoma who have unstable conditions despite current medication.
✕Probably not a fit
Patients with secondary glaucoma or those who have undergone previous glaucoma surgeries are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there have been studies on trabeculectomy, the comparison with deep sclerectomy in this specific context is relatively novel.
Who can join: the full rules
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 it's running
-
Helsinki University Central Hospital
Helsinki, Finland Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Electrical stimulation treatment for visual field defects in glaucoma patients
This study is testing if a new electrical stimulation treatment can help people with glaucoma keep their vision from getting worse while they continue using their regular eye drops.
-
Combining endoscopic cyclophotocoagulation with cataract surgery for normal tension glaucoma
This study is testing if adding a special eye treatment during cataract surgery can help people with normal tension glaucoma lower their eye pressure better than cataract surgery alone.
-
Exploring blood flow and nerve health in glaucoma patients and healthy individuals
This study is trying to see how blood flow affects nerve health in people with glaucoma compared to healthy individuals to find ways to protect vision.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.