Status:
COMPLETED
Assessment of Effectiveness Ex-Press Surgery Modification
Lead Sponsor:
Military Institute od Medicine National Research Institute
Conditions:
Glaucoma, Open-Angle
Glaucoma Secondary
Eligibility:
All Genders
21+ years
Phase:
NA
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 phacoemulsifi...
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 hypotensiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT03800589
Start Date
December 1 2010
End Date
December 1 2017
Last Update
January 16 2019
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