Assessment of Effectiveness Ex-Press Surgery Modification

Not Applicable

Completed

• Conditions: Glaucoma, Open-Angle; Glaucoma Secondary; Glaucoma, Primary Open Angle
• Interventions: Procedure: phacoemulsification with implantation of the Ex-Press; Procedure: deep sclerectomy, phacoemulsification, ExPress implantation

• Registration Number: NCT03800589
• Lead Sponsor: Military Institute od Medicine National Research Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-12-01
• Primary Completion: 2016-12-01
• Study Completion: 2017-12-01
• Status Verified: 2019-01
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-11
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
phaco and Ex-Press	phacoemulsification with implantation of the Ex-Press	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
deep sclerectomy, phaco and Ex-press	deep sclerectomy, phacoemulsification, ExPress implantation	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

Primary Outcome Measures

Name	Time	Method
CDVA	baseline, and 24th month after surgery	the change in corrected distance visual acuity
IOP	baseline, and 24th month after surgery	the change in level of intraocular pressure
number of drugs	baseline, and 24th month after surgery	the change in number of antiglaucoma medications

Secondary Outcome Measures

Name	Time	Method
number of complications	in a day of surgery	rate of complications