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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