Clinical trial NCT03800589: Assessment of Effectiveness Ex-Press Surgery Modification
Official title: Comparison of ExPress Implantation Versus Partial Deep Sclerectomy Combined With ExPress Implantation With Simultaneously Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma, Open-Angle
Glaucoma Secondary
Glaucoma, Primary Open Angle
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 186
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized control study with 24-month follow-up.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: IOP
timeFrame: baseline, and 24th month after surgery
measure: CDVA
timeFrame: baseline, and 24th month after surgery
measure: number of drugs
timeFrame: baseline, and 24th month after surgery
Secondary outcomes:
measure: number of complications
timeFrame: in a day of surgery
Other outcomes:
Locations:
Study officials:
affiliation: Military Institute of Medicine in Warsaw
name: Marek Rękas, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.