Assessment of Effectiveness Ex-Press Surgery Modification

Sponsor

Military Institute of Medicine, Poland (Other)

Overall Status

Completed

CT.gov ID

NCT03800589

Collaborator

(none)

186

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle Glaucoma Secondary Glaucoma, Primary Open Angle	Procedure: phacoemulsification with implantation of the Ex-Press Procedure: deep sclerectomy, phacoemulsification, ExPress implantation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

186 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, randomized control study with 24-month follow-up.Prospective, randomized control study with 24-month follow-up.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

number of complications [in a day of surgery]
rate of complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Military Institute of Medicine, Poland

Investigators

Principal Investigator: Marek Rękas, Prof, Military Institute of Medicine in Warsaw

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Military Institute of Medicine, Poland

ClinicalTrials.gov Identifier:

NCT03800589

Other Study ID Numbers:

15/WIM/2010

First Posted:

Jan 11, 2019

Last Update Posted:

Jan 16, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glaucoma

Glaucoma, Open-Angle

Study Results

No Results Posted as of Jan 16, 2019