QoL Assessment in Traditional Glaucoma Surgery and MIGS.

Sponsor

Military Institute of Medicine, Poland (Other)

Overall Status

Unknown status

CT.gov ID

NCT03613233

Collaborator

(none)

400

Enrollment

Location

Arms

Anticipated Duration (Months)

14.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Procedure: Glaucoma surgery	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Quality of Life Assessment in Traditional and Microinvasive Glaucoma Surgery.

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: traditional glaucoma surgery glaucoma procedures such as trabeculectomy, iridencleisis, non - penetrating deep sclerectomy	Procedure: Glaucoma surgery phacoemulsification Other Names: cataract surgery when required
Active Comparator: microinvasive glaucoma surgery (MIGS) glaucoma procedures such as : canaloplasty (traditional, ABiC, modified), iStent, XEN, Cypass,Hydrus- and with any other microinvasive IOP reducing device	Procedure: Glaucoma surgery phacoemulsification Other Names: cataract surgery when required

Arm

Intervention/Treatment

Active Comparator: traditional glaucoma surgery

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

Procedure: Glaucoma surgery

phacoemulsification

Other Names:

cataract surgery when required

Active Comparator: microinvasive glaucoma surgery (MIGS)

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

Procedure: Glaucoma surgery

phacoemulsification

Other Names:

cataract surgery when required

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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