DSTRENTG: Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma

Helsinki University Central Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Trabeculectomy
  • Procedure: Deep Sclerectomy

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.

Study Design

Study Type:
Anticipated Enrollment :
80 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Glaucoma patient

Procedure: Trabeculectomy
trabeculectomy glaucoma surgery

Procedure: Deep Sclerectomy
deep sclerectomy glaucoma surgery

Outcome Measures

Primary Outcome Measures

  1. Success Rate [One year]

    Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications

Secondary Outcome Measures

  1. Success Rate [5 years]

    Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications

Eligibility Criteria


Ages Eligible for Study:
55 Years to 100 Years
Sexes Eligible for Study:
Accepts 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

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Helsinki University Central Hospital


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Nina Lindbohm, Principal Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
First Posted:
May 12, 2022
Last Update Posted:
May 12, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2022