Assessment of Effectiveness Ex-Press Surgery Modification

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma, Open-Angle; Glaucoma, Primary Open Angle; Glaucoma Secondary
• Intervention / Treatment: Procedure: phacoemulsification with implantation of the Ex-Press; Procedure: deep sclerectomy, phacoemulsification, ExPress implantation

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 Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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.
Active Comparator: 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	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Military Institute of Medicine, Poland
• Investigators: Principal Investigator: Marek Rękas, Prof, Military Institute of Medicine in Warsaw

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2010
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 15/WIM/2010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: Data will be available within 18 months of study completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the Chair Person. Requestors will be required to sign a Data Access Agreement
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No