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Clinical Trials/NCT03613233
NCT03613233
Unknown
Not Applicable

Quality of Life Assessment in Traditional and Microinvasive Glaucoma Surgery.

Military Institute od Medicine National Research Institute1 site in 1 country400 target enrollmentJanuary 1, 2018
ConditionsGlaucoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glaucoma
Sponsor
Military Institute od Medicine National Research Institute
Enrollment
400
Locations
1
Primary Endpoint
NEI VFQ 25 quality of life score change
Last Updated
7 years ago

Overview

Brief Summary

Quality of Life assessment before and after various glaucoma surgery (traditional and microinvasive (MIGS)).

Detailed Description

Patients qualified for glaucoma surgical procedure fill in QoL questionnaire (NEI VFQ 25) at baseline (pre-operatively) and 3 months after glaucoma surgery. Additional data will be collected such as demographic data and medical data, visual acuity, intraocular pressure, number of glaucoma medications, stage of glaucoma based on visual field assessment, medical ophthalmic history, intra and postoperative complications, postoperative interventions.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
April 1, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Military Institute od Medicine National Research Institute
Responsible Party
Principal Investigator
Principal Investigator

Marek Rekas

płk prof. Marek RĘKAS, MD, PhD

Military Institute od Medicine National Research Institute

Eligibility Criteria

Inclusion Criteria

  • patients qualified for glaucoma surgery in Military Institute of Medicine - based on following Inclusion Criteria:
  • all glaucoma types with characteristic glaucoma changes (biomicroscopic ,visual field) with documented glaucoma progression
  • patients not tolerating antiglaucoma medications,
  • patients with poor compliance
  • progression in visual field

Exclusion Criteria

  • active inflammatory disease
  • pregnancy
  • mental disease or emotional instability
  • general steroid therapy
  • inability to fill in the questionnaire

Outcomes

Primary Outcomes

NEI VFQ 25 quality of life score change

Time Frame: baseline (0-30 days; pre-operative) and three months after surgery

NEI VFQ 25 baseline and 3 months after surgery

Study Sites (1)

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