QoL Assessment in Traditional Glaucoma Surgery and MIGS.

Not Applicable

• Conditions: Glaucoma
• Interventions: Procedure: Glaucoma surgery

• Registration Number: NCT03613233
• Lead Sponsor: Military Institute od Medicine National Research Institute

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-06-29
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-29
• Last Update Submitted: 2018-07-29
• Study First Posted: 2018-08-03
• Last Update Posted: 2018-08-03
• Primary Completion: 2020-01-01
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
microinvasive glaucoma surgery (MIGS)	Glaucoma surgery	glaucoma procedures such as : canaloplasty (traditional, ABiC, modified), iStent, XEN, Cypass,Hydrus- and with any other microinvasive IOP reducing device
traditional glaucoma surgery	Glaucoma surgery	glaucoma procedures such as trabeculectomy, iridencleisis, non - penetrating deep sclerectomy

Primary Outcome Measures

Name	Time	Method
NEI VFQ 25 quality of life score change	baseline (0-30 days; pre-operative) and three months after surgery	NEI VFQ 25 baseline and 3 months after surgery

Trial Locations

Locations (1)

Military Institute of Medicine; 🇵🇱 Warsaw, Poland