Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma

ConditionNormal Tension Glaucoma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age55-100

SponsorHelsinki University Central Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Secondary Glaucoma e.g. due to previous injury or uveitis

Exfoliation syndrome

Pigment dispersion syndrome

Previous transscleral or endoscopic cyclophotocoagulation

Trial design

Design model

Single group

Treatments tested in this trial

Trabeculectomy
Procedure/Surgery
trabeculectomy glaucoma surgery
Deep Sclerectomy
Procedure/Surgery
deep sclerectomy glaucoma surgery

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Deep sclerectomyExperimental treatment 1 intervention

Group B: TrabeculectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

Success Rate

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

Time frame

One year

Secondary outcomes

Success Rate

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

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helsinki University Central Hospital

Lead sponsor

Source ClinicalTrials.gov

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