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Deep 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
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Normal Tension Glaucoma

Eligibility Criteria

55 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 2, 2022
Last Updated
August 26, 2022
Sponsor
Helsinki University Central Hospital
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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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