Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
Recruiting · NCT05371977 · Interventional (participants receive a specific treatment) · Lead sponsor: Helsinki University Central Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Deep SclerectomyTrabeculectomy
What this trial is about
The purpose of this study is to assess whether deep sclerectomy is as effective in lowering intraocular pressure (IOP) as trabeculectomy in patients with normal tension glaucoma.
Who can take part
Age range
55 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Helsinki University Central Hospital - Helsinki, Finland