Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma

NCT ID: NCT05371977

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2029-05-31

Brief Summary

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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

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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.

Conditions

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Normal Tension Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deep sclerectomy

Group Type EXPERIMENTAL

Deep Sclerectomy

Intervention Type PROCEDURE

deep sclerectomy glaucoma surgery

Trabeculectomy

Group Type ACTIVE_COMPARATOR

Trabeculectomy

Intervention Type PROCEDURE

trabeculectomy glaucoma surgery

Interventions

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Trabeculectomy

trabeculectomy glaucoma surgery

Intervention Type PROCEDURE

Deep Sclerectomy

deep sclerectomy glaucoma surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nina Lindbohm

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helsinki University Central Hospital

Helsinki, , Finland

Site Status RECRUITING

Countries

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Finland

Facility Contacts

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Nina Lindbohm, MD, PhD

Role: primary

+358 9 4711

Other Identifiers

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DSTRENTG

Identifier Type: -

Identifier Source: org_study_id

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