Assessment of Effectiveness Ex-Press Surgery Modification

Study Overview
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Brief Summary
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The purpose of the study is to compare the effectiveness and safety profile of ExPress implantation versus partial deep sclerectomy combined with ExPress implantation with simultaneously phacoemulsification.

Detailed Description
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Mermoud et all (1) proposed a modification of the classical surgical technique: combined deep sclerectomy (DS) with ExPress device implantation. The goal of this modification was to enhance hypotensive effect of well known procedure, and also to simplify non-penetrating surgery, which is a procedure with a long learning curve. Mermoud's idea provides the possibility of avoiding complications related to dissection of the filtering bleb and gives hope for achieve of better results in comparison to the classical procedure. Thanks to this, the surgical procedure could be performed earlier, even in the case of glaucoma with low intraocular pressure (IOP), where vascular factors are largely responsible for the progression of neuropathy. To demonstrate the potential of both types of procedures with the application of the ExPress implant, the authors decided to conduct a prospective, randomized study with a 2-year observation period concerning the efficacy, safety and stability of effects achieved.

Official Title
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Comparison of ExPress Implantation Versus Partial Deep Sclerectomy Combined With ExPress Implantation With Simultaneously Phacoemulsification

Conditions
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Glaucoma, Open-Angle, Glaucoma Secondary, Glaucoma, Primary Open Angle

Intervention / Treatment
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* Procedure: phacoemulsification with implantation of the Ex-Press
* Procedure: deep sclerectomy, phacoemulsification, ExPress implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic, documented progression of loss of field of vision, significant daily IOP fluctuations, no cooperation from patient with regard to application of anti-glaucoma treatment, allergy to topical medication written consent to involvement and participation in the study for a period of at least 24 months Exclusion Criteria: no consent to participation in the study prior surgical and laser procedures in the area of the eye narrow- or closed-angle glaucoma post-inflammatory or post-traumatic secondary glaucoma chronic illness of the cornea or optic nerve advanced macular degeneration active inflammatory process pregnancy systemic steroid therapy

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized control study with 24-month follow-up.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: phaco and Ex-Press<br>patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to phacoemulsification with implantation of the Ex-Press | Procedure: phacoemulsification with implantation of the Ex-Press<br>* The conjunctiva is dissected with the base in the limbus. A square scleral flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Mini seton was implanted at 12 o'clock according to the standard technique.<br>|
| Active Comparator: deep sclerectomy, phaco and Ex-press<br>patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to deep sclerectomy, phacoemulsification, ExPress implantation | Procedure: deep sclerectomy, phacoemulsification, ExPress implantation<br>* The conjunctiva is dissected with the base in the limbus. Superficial flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Deep scleral is dissected just below the trabeculo-Descemet membrane. The seton is implanted in the anterior chamber at the height of Schlemm's Canal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP | the change in level of intraocular pressure | baseline, and 24th month after surgery | 
| CDVA | the change in corrected distance visual acuity | baseline, and 24th month after surgery | 
| number of drugs | the change in number of antiglaucoma medications | baseline, and 24th month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of complications | rate of complications | in a day of surgery |