Visual Acuity and Optical Coherence Tomography One Year A... | NCT03583632

Studies
Visual Acuity and Optical Coherence Tomography One Year After Peeling of Epiretinal Membranes

NCT03583632

Sponsor

Vienna Institute for Research in Ocular Surgery

Status

Completed

Last Update Posted

Mar 15, 2024Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Epiretinal Membrane

Interventions

visual acuity testing
optical coherence tomography

Countries

Austria

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Jun 28, 2018

First Submission Date that Met QC Criteria

Jun 28, 2018

First Posted Date

Jul 11, 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

Mar 13, 2024

Last Update Posted Date

Mar 15, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prim. Prof. Dr. Oliver Findl, MBA, Head of the Department of Ophthalmology, Professor, Principal Investigator, Vienna Institute for Research in Ocular SurgeryPrincipal Investigator

Lead Sponsor

Vienna Institute for Research in Ocular SurgeryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Improvement in visual acuity and retinal anatomy one year after surgery is assessed and compared to data preoperative and 3 months after surgery

Detailed Description

Improvement in visual acuity and retinal anatomy (documented by optical coherence tomography) one year after surgery is assessed and compared to data preoperative and 3 months after surgery. Improvements in retinal morphology are analysed by remission of optical coherence biomarkers after surgery. Aim of the study is to examine possible improvements of surgical outcomes in the period up to the one year follow-up.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
visual acuity testing	Other	testing of visual ycuity by ETDRS charts
optical coherence tomography	Device	optical coherence tomography generates sectional slides of the retinal tomography with light

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual acuity	visual acuity testing with EDTRS charts	3 minutes

Secondary Outcomes

Measure	Description	Time Frame
optical coherence tomography	optical coherence tomography generates slides of the retinal anatomy with light	3 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

vitrectomy with Membrane Peeling due to an epiretinal membrane

Exclusion Criteria:

none

Accepts Healthy Volunteers

Not provided

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

For this study only patients after vitrectomy with Membrane Peeling due to epiretinal membranes are selected

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oliver Findl, MD, Prof	VIROS at Hanuschkrankenhaus Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna		Vienna		1140	Austria

Condition Browse Module

MeSH Terms

ID	Term
D019773	Epiretinal Membrane

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D041623	Tomography, Optical Coherence

Ancestor Terms

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided