Efficacy and Safety of the ExPRESS Implant Versus Deep Sclerectomy in Combined Surgery
Open Angle Glaucoma, Ocular Hypertension
About this trial
This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Glaucoma, Ocular hypertension, Filtration surgery, Trabeculectomy with Ex-PRESS, Non penetrating deep sclerectomy, Phacoemulsification, Combined surgery
Eligibility Criteria
Inclusion Criteria:
Diagnosis of open-angle glaucoma. Points a, b and c will be required:
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.
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
- III or IV angle in Shaffer classification
- Disease poorly controlled with medical treatment and/or laser at the discretion of the ophthalmologist (progression, higher than targeted pressure, poor compliance…)
- Cataract with visual acuity between 0,1 (20/200) and 0.8 (20/25)
Exclusion Criteria:
- Inflammatory, neovasular, closed-angle, normotensive glaucoma secondary to corticoids, or any type of glaucoma with advanced degree of functional lesion (Mean Defect < -20 dB)
- Previous glaucoma surgery
- Previous intraocular ocular surgery
Sites / Locations
- Institut Catala de Retina
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Filtration surgery with Express
Non penetrating surgery
Filtration surgery with Ex-PRESS + cataract extraction (Cataract surgery and IOL implantation)
- Filtration surgery with Non penetrating deep sclerectomy + cataract extraction (Cataract surgery and IOL implantation)