Assessment of Effectiveness Ex-Press Surgery Modification

NCT ID: NCT03800589

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-01
• Study Completion Date: 2017-12-01

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.

Conditions

Glaucoma, Open-Angle; Glaucoma Secondary; Glaucoma, Primary Open Angle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

phaco and 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

Group Type: ACTIVE_COMPARATOR

phacoemulsification with implantation of the Ex-Press

Intervention Type: PROCEDURE

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.

deep sclerectomy, phaco and Ex-press

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

Group Type: ACTIVE_COMPARATOR

deep sclerectomy, phacoemulsification, ExPress implantation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Military Institute od Medicine National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marek Rękas, Prof

Role: PRINCIPAL_INVESTIGATOR

Military Institute of Medicine in Warsaw

References

Bissig A, Feusier M, Mermoud A, Roy S. Deep sclerectomy with the Ex-PRESS X-200 implant for the surgical treatment of glaucoma. Int Ophthalmol. 2010 Dec;30(6):661-8. doi: 10.1007/s10792-010-9382-z. Epub 2010 Jun 16.

Reference Type: RESULT

PMID: 20552258 (View on PubMed)

Other Identifiers

15/WIM/2010

Identifier Type: -

Identifier Source: org_study_id