Back to results

QoL Assessment in Traditional Glaucoma Surgery and MIGS.

Primary Purpose

Glaucoma

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Glaucoma surgery

About this trial

This is an interventional supportive care trial for Glaucoma focused on measuring MIGS, canaloplasty, glaucoma, glaucoma surgery, glaucoma implant, deep sclerectomy, iridencleisis, QoL, quality of life, NEI VFQ 25

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Military Institute of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

traditional glaucoma surgery

microinvasive glaucoma surgery (MIGS)

Arm Description

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

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

Outcomes

Primary Outcome Measures

NEI VFQ 25 quality of life score change

NEI VFQ 25 baseline and 3 months after surgery

Secondary Outcome Measures

Full Information

NCT ID

NCT03613233

First Posted

June 29, 2018

Last Updated

July 29, 2018

Sponsor

Military Institute od Medicine National Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT03613233

Brief Title

QoL Assessment in Traditional Glaucoma Surgery and MIGS.

Official Title

Quality of Life Assessment in Traditional and Microinvasive Glaucoma Surgery.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

January 1, 2020 (Anticipated)

Study Completion Date

April 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Military Institute od Medicine National Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

MIGS, canaloplasty, glaucoma, glaucoma surgery, glaucoma implant, deep sclerectomy, iridencleisis, QoL, quality of life, NEI VFQ 25

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

traditional glaucoma surgery

Arm Type

Active Comparator

Arm Description

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

Arm Title

microinvasive glaucoma surgery (MIGS)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Glaucoma surgery

Other Intervention Name(s)

cataract surgery when required

Intervention Description

phacoemulsification

Primary Outcome Measure Information:

Title

NEI VFQ 25 quality of life score change

Description

NEI VFQ 25 baseline and 3 months after surgery

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Byszewska, MD, PhD

Phone

500285890

Ext

ania.byszewska@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Marek Rękas, prof.; MD; PhD

mrekas@wim.mil.pl

Facility Information:

Facility Name

Military Institute of Medicine

City

Warsaw

ZIP/Postal Code

04-141

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Byszewska, MD,PhD

Phone

500285890

Ext

ania.byszewska@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

QoL Assessment in Traditional Glaucoma Surgery and MIGS.

We'll reach out to this number within 24 hrs