Efficacy and Safety of the ExPRESS Implant Versus Deep Sclerectomy in Combined Surgery

About this trial

Last updated 9 years ago

Study ID

ICR-01 Ex-PRESS

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Ended 10 years ago

What is this trial about?

The Ex-PRESS Glaucoma Filtration Device is a small, non-valved implant that was designed to lower intraocular pressure (IOP) by shunting aqueous humor from the anterior chamber into the subconjunctival space. The implant was developed in response to the need for more straightforward, standardized and safe surgical technique than standard filtration surgery. No iridectomy and no sclerectomy is needed if an Ex-PRESS device is implanted under a partial-thickness scleral flap. This may reduce surgical time and complications when compared to a standard trabeculectomy. In some studies it has been found to be safe and effective with few complications, even in high-risk patients. No previous studies have compared filtration surgery with Ex-Press implant to deep sclerectomy.

What are the participation requirements?

Inclusion Criteria

1. Diagnosis of open-angle glaucoma. Points a, b and c will be required:

1. Glaucomatous visual field. Defined as the field presenting at least:

* A group of 3 or more points with p < 5% in the pattern deviation map AND

* One of them with a p < 1% in the pattern deviation map AND

* Repeated in at least 2 VF.

2. Glaucomatous optic nerve. Defined as the optic nerve observed in color photographs presenting:

* Thinning of the neuroretinal rim that can be demonstrated by an alteration in the ISNT rule.

* Presence of a notch "or"

* Presence of papillary splinter hemorrhage "or"

* Presence of a nerve fiber layer defect "or"

* Cup to disc (C/D) ratio asymmetry > 0.3 that cannot be explained by asymmetry in the optic disc size "or"

* C/D ratio > 0.8 that cannot be explained by a large optic disc size

3. III or IV angle in Shaffer classification

2. Disease poorly controlled with medical treatment and/or laser at the discretion of the ophthalmologist (progression, higher than targeted pressure, poor compliance…)

3. Cataract with visual acuity between 0,1 (20/200) and 0.8 (20/25)

Exclusion Criteria

1. Inflammatory, neovasular, closed-angle, normotensive glaucoma secondary to corticoids, or any type of glaucoma with advanced degree of functional lesion (Mean Defect < -20 dB)

2. Previous glaucoma surgery

3. Previous intraocular ocular surgery