Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trabeculectomy, Deep Sclerectomy.
- Who it may be relevant to
- Registry conditions: Normal Tension Glaucoma. Basic parameters: 55 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Subjects with normal tension glaucoma that is unstable with current medication needing filtration surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having deep sclerectomy or trabeculectomy.
Interventions
- Procedure Trabeculectomy
trabeculectomy glaucoma surgery - Procedure Deep Sclerectomy
deep sclerectomy glaucoma surgery
Primary outcome measures
- Success Rate [Time frame: One year]
Secondary outcome measures (1)
- Success Rate [Time frame: 5 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Finland · 1 center
- Helsinki University Central Hospital — Helsinki
Identifiers
NCT: NCT05371977 · DSTRENTG