QoL Assessment in Traditional Glaucoma Surgery and MIGS. | NCT03613233

Studies
QoL Assessment in Traditional Glaucoma Surgery and MIGS.

NCT03613233

Sponsor

Military Institute od Medicine National Research Institute

Status

Unknown status

Last Update Posted

Aug 3, 2018Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Glaucoma

Interventions

Glaucoma surgery

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Jan 1, 2020Estimated

Completion Date

Apr 1, 2020Estimated

First Submitted Date

Jun 29, 2018

First Submission Date that Met QC Criteria

Jul 29, 2018

First Posted Date

Aug 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2018

Last Update Posted Date

Aug 3, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marek Rekas, płk prof. Marek RĘKAS, MD, PhD, Military Institute od Medicine National Research InstitutePrincipal Investigator

Lead Sponsor

Military Institute od Medicine National Research InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Glaucoma surgery	Procedure	phacoemulsification	microinvasive glaucoma surgery (MIGS) traditional glaucoma surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anna Byszewska, MD, PhD	Contact	500285890	48	ania.byszewska@gmail.com
Marek Rękas, prof.; MD; PhD	Contact			mrekas@wim.mil.pl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Military Institute of Medicine	Recruiting	Warsaw		04-141	Poland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided