Assessment of Effectiveness Ex-Press Surgery Modification

• ClinicalTrials.gov Identifier: NCT03800589
• Recruitment Status: Completed
• First Posted: January 11, 2019
• Last Update Posted: January 16, 2019
• Sponsor: Military Institute of Medicine, Poland
• Information provided by (Responsible Party): Military Institute of Medicine, Poland

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	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 186 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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: December 1, 2010
• Actual Primary Completion Date: December 1, 2016
• Actual Study Completion Date: December 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.

Outcome Measures

Primary Outcome Measures :

1. IOP [ Time Frame: baseline, and 24th month after surgery ]
   the change in level of intraocular pressure
2. CDVA [ Time Frame: baseline, and 24th month after surgery ]
   the change in corrected distance visual acuity
3. number of drugs [ Time Frame: baseline, and 24th month after surgery ]
   the change in number of antiglaucoma medications

Secondary Outcome Measures :

1. number of complications [ Time Frame: in a day of surgery ]
   rate of complications

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Sponsors and Collaborators

Military Institute of Medicine, Poland

Investigators

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

More Information

Publications of Results:

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.

• Responsible Party: Military Institute of Medicine, Poland
• ClinicalTrials.gov Identifier: NCT03800589
• Other Study ID Numbers: 15/WIM/2010
• First Posted: January 11, 2019
• Last Update Posted: January 16, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Eye Diseases