QoL Assessment in Traditional Glaucoma Surgery and MIGS.

Military Institute od Medicine National Research Institute

Status: Unknown

Conditions: Glaucoma

Treatments: Procedure: Glaucoma surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03613233

0000000417

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

traditional glaucoma surgery

Active Comparator group

Description:

glaucoma procedures such as trabeculectomy, iridencleisis, non - penetrating deep sclerectomy

Treatment:

Procedure: Glaucoma surgery

microinvasive glaucoma surgery (MIGS)

Active Comparator group

Description:

glaucoma procedures such as : canaloplasty (traditional, ABiC, modified), iStent, XEN, Cypass,Hydrus- and with any other microinvasive IOP reducing device

Treatment:

Procedure: Glaucoma surgery