Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
DSTRENTG
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2022
CompletedFirst Posted
Study publicly available on registry
May 12, 2022
CompletedStudy Start
First participant enrolled
May 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
ExpectedMarch 15, 2024
March 1, 2024
3.9 years
May 2, 2022
March 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Success Rate
Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications
One year
Secondary Outcomes (1)
Success Rate
5 years
Study Arms (2)
Deep sclerectomy
EXPERIMENTALTrabeculectomy
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Helsinki University Central Hospital
Helsinki, 00990, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 2, 2022
First Posted
May 12, 2022
Study Start
May 31, 2022
Primary Completion
May 1, 2026
Study Completion (Estimated)
May 1, 2029
Last Updated
March 15, 2024
Record last verified: 2024-03