NCT03800589

Assessment of Effectiveness Ex-Press Surgery Modification

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Military Institute od Medicine National Research Institute · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Glaucoma, Open-Angle
• Glaucoma Secondary
• Glaucoma, Primary Open Angle

Interventions

Type	Name	Description
PROCEDURE	phacoemulsification with implantation of the Ex-Press	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.
PROCEDURE	deep sclerectomy, phacoemulsification, ExPress implantation	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.

Timeline

• Start date: 2010-12-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2019-01-11
• Last updated: 2019-01-16