Observational Study - ILM Peeling | NCT01083056

Studies
Observational Study - ILM Peeling

NCT01083056

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Jul 31, 2014Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Epimacular Gliosis
Macular Hole

Interventions

Not provided

Countries

Germany

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 2014

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

Mar 2010

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Mar 8, 2010

First Submission Date that Met QC Criteria

Mar 8, 2010

First Posted Date

Mar 9, 2010Estimated

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 30, 2014

Last Update Posted Date

Jul 31, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

M. Dominik Fischer, PD Dr. med. M. Dominik Fischer, University Hospital TuebingenPrincipal Investigator

Lead Sponsor

University Hospital TuebingenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This observational study investigates the effects of epimacular membrane peeling on the structure and function of the retina.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Measure	Description	Time Frame
BCVA		6 months after ILM peeling

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Epimacular Gliosis
Must be scheduled for ILM-peeling independently of study
Must be older then 18 years of age

Exclusion Criteria:

Visual acuity > 0,4 logMAR (< 20/50 EDTRS)
Other ophthalmological disorder affecting visual acuity and/or visual field and/or retinal structure

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

Inpatients at the University Eye Hospital Tuebingen

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Florian Gekeler, MD	Centre for Ophthalmology, University Hospital Tuebingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Ophthalmology, University Hospital Tuebingen		Tübingen	Baden-Wurttemberg	72076	Germany

Condition Browse Module

MeSH Terms

ID	Term
D012167	Retinal Perforations
D005911	Gliosis

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Epimacular Gliosis Without Macular Hole
Epimacular Gliosis With Macular Hole