Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05371977

Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Normal Tension Glaucoma Eye Diseases Glaucoma Low Tension Glaucoma Ocular Hypertension Optic Nerve Diseases

Age range

55 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital

Helsinki, 00990, Finland

Location status: Recruiting

Location contact

Nina Lindbohm, MD, PhD

CONTACT

[email protected]

+358 9 4711

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

trabeculectomy

Procedure

trabeculectomy glaucoma surgery

deep sclerectomy

Procedure

deep sclerectomy glaucoma surgery

Primary outcomes

  1. Success Rate

    Time frame: One year

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

Secondary outcomes

  1. Success Rate

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Acronym: DSTRENTG

Important dates

Study start
2022
Primary completion
2026
Study completion
2029
First posted
May 12, 2022
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.