Back to resultsDeep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma (DSTRENTG)
Primary Purpose
Normal Tension Glaucoma
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Trabeculectomy
Deep Sclerectomy
Sponsored by
About this trial
This is an interventional treatment trial for Normal Tension Glaucoma
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
Sites / Locations
- Helsinki University Central HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Glaucoma patient
Arm Description
Outcomes
Primary Outcome Measures
Success Rate
Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications
Secondary Outcome Measures
Success Rate
Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications
Full Information
NCT ID
NCT05371977
First Posted
May 2, 2022
Last Updated
August 26, 2022
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05371977
Brief Title
Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
Acronym
DSTRENTG
Official Title
Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Tension Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glaucoma patient
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Trabeculectomy
Intervention Description
trabeculectomy glaucoma surgery
Intervention Type
Procedure
Intervention Name(s)
Deep Sclerectomy
Intervention Description
deep sclerectomy glaucoma surgery
Primary Outcome Measure Information:
Title
Success Rate
Description
Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications
Time Frame
One year
Secondary Outcome Measure Information:
Title
Success Rate
Description
Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00990
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Lindbohm, MD, PhD
Phone
+358 9 4711
Email
nina.lindbohm@hus.fi
12. IPD Sharing Statement
Learn more about this trial
Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
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