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NCT05371977 Clinical Trial

Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma

Normal Tension Glaucoma Clinical Trial

— DSTRENTG  

Official title:
Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05371977
Other study ID # DSTRENTG
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 31, 2022
Est. completion date May 2029

Study information
Verified date March 2024
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date May 2029
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 55 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Trabeculectomy
trabeculectomy glaucoma surgery
• Deep Sclerectomy
deep sclerectomy glaucoma surgery

Locations
Country Name City State
Finland Helsinki University Central Hospital Helsinki

Sponsors (1)
Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Success Rate Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications One year
Secondary Success Rate Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications 5 years
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