NCT00941291

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2002

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2002

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
Last Updated

July 17, 2009

Status Verified

July 1, 2009

First QC Date

March 30, 2009

Last Update Submit

July 16, 2009

Conditions

Idiopathic Macular Hole

Keywords

idiopathic macular holecataractedemaReopening

Outcome Measures

Primary Outcomes (1)

  • Long-term outcome of idiopathic macular hole surgery

    37 months

Study Arms (4)

vitrectomy in pseudophakic eyes

vitrectomy and cataract:combined procedure

vitrectomy followed by cataract extraction

vitrectomy on phakic eyes

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Unit CHU Dijon

Dijon, Burgundy, 21000, France

Location

Related Publications (1)

  • 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.

    PMID: 19846059DERIVED

MeSH Terms

Conditions

CataractEdema

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine Creuzot-Gracher, MD, PhD

    Ophthalmology unit CHU Dijon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2009

First Posted

July 17, 2009

Study Start

January 1, 2002

Study Completion

January 1, 2005

Last Updated

July 17, 2009

Record last verified: 2009-07

Locations

FR(1)