Outcome of Idiopathic Macular Hole | NCT00941291

Studies
Outcome of Idiopathic Macular Hole

NCT00941291

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Jul 17, 2009Estimated

Enrollment

135Actual

Phase

Not provided

Conditions

Idiopathic Macular Hole

Interventions

Not provided

Countries

France

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 2009

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

Jan 2002

Primary Completion Date

Not provided

Completion Date

Jan 2005Actual

First Submitted Date

Mar 30, 2009

First Submission Date that Met QC Criteria

Jul 16, 2009

First Posted Date

Jul 17, 2009Estimated

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 16, 2009

Last Update Posted Date

Jul 17, 2009Estimated

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

The purpose of this study is to evaluate the role of cataract surgery and cystoid macular edema (CME) on reopening of idiopathic macular holes (IMH).

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

135Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vitrectomy in pseudophakic eyes
vitrectomy and cataract:combined procedure
vitrectomy followed by cataract extraction
vitrectomy on phakic eyes

Interventions

Not provided

Measure	Description	Time Frame
Long-term outcome of idiopathic macular hole surgery		37 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with with stage 2, 3, or 4 Idiopathic Macular Hole after successful Idiopathic Macular Hole repair

Exclusion Criteria:

All patients without stage 2, 3, or 4 Idiopathic Macular Hole repair

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

One hundred and thirty patients (135 eyes) with stage 2, 3, or 4 IMH were included after successful IMH repair

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Catherine Creuzot-Gracher, MD, PhD	Ophthalmology unit CHU Dijon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmology Unit CHU Dijon		Dijon	Burgundy	21000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19846059	Derived	Passemard M, Yakoubi Y, Muselier A, Hubert I, Guillaubey A, Bron AM, Berrod JP, Creuzot-Garcher C. Long-term outcome of idiopathic macular hole surgery. Am J Ophthalmol. 2010 Jan;149(1):120-6. doi: 10.1016/j.ajo.2009.08.003. Epub 2009 Oct 20.

ID	Term
D002386	Cataract
D004487	Edema

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms