NCT03613233

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

August 3, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

June 29, 2018

Last Update Submit

July 29, 2018

Conditions

Glaucoma

Keywords

MIGScanaloplastyglaucomaglaucoma surgeryglaucoma implantdeep sclerectomyiridencleisisQoLquality of lifeNEI VFQ 25

Outcome Measures

Primary Outcomes (1)

  • NEI VFQ 25 quality of life score change

    NEI VFQ 25 baseline and 3 months after surgery

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

Study Arms (2)

traditional glaucoma surgery

ACTIVE COMPARATOR

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

Procedure: Glaucoma surgery

microinvasive glaucoma surgery (MIGS)

ACTIVE COMPARATOR

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

Procedure: Glaucoma surgery

Interventions

Glaucoma surgeryPROCEDURE

phacoemulsification

Also known as: cataract surgery when required
microinvasive glaucoma surgery (MIGS)traditional glaucoma surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Institute of Medicine

Warsaw, 04-141, Poland

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Central Study Contacts

Anna Byszewska, MD, PhD

CONTACT

500285890ania.byszewska@gmail.com

Marek Rękas, prof.; MD; PhD

CONTACT

mrekas@wim.mil.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
płk prof. Marek RĘKAS, MD, PhD

Study Record Dates

First Submitted

June 29, 2018

First Posted

August 3, 2018

Study Start

January 1, 2018

Primary Completion

January 1, 2020

Study Completion

April 1, 2020

Last Updated

August 3, 2018

Record last verified: 2018-07

Locations

PL(1)