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Combined Versus Successive Macular Hole and Cataract Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01069029
First Posted: February 17, 2010
Last Update Posted: February 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre Hospitalier Universitaire Dijon
  Purpose
The purpose of this study is to compare functional and anatomical results of a combined surgery and two time surgery for macular hole and cataract extraction in one hundred and twenty patients (120 eyes) with idiopathic Macular Hole (MH) and cataract in two academic centers.

Condition
Macular Hole Visual Acuity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Macular Hole and Cataract Extraction: Combined Surgery Versus Two Times Surgery

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Post surgical procedure assessment of Visual acuity [ Time Frame: 6 and 12 months post surgery ]

Secondary Outcome Measures:
  • Rate of closure of macular hole by OCT [ Time Frame: at 6 and 12 months post surgery ]

Enrollment: 120
Study Start Date: January 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Combined surgery
Patient which underwent combined surgery of MH and cataract extraction
Successive surgery
Patients which underwent the two successive procedures

Detailed Description:
Main outcome measures were the assessment of visual acuity at 6 and 12 months,and the rate of closure of MH by OCT (optical coherence tomography).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with symptomatic visual loss and needed vitrectomy for Macular Hole treatment.
Criteria

Inclusion Criteria:

  • Macular Hole Stage 2,3,and 4
  • Visual loss
  • At least 18 years of age

Exclusion Criteria:

  • Stage of Macular Hole Stage 1
  • Macular hole post traumatism or associated with retinal detachment
  • Diabetic retinopathy
  • Glaucoma
  • Age-related macular degeneration
  • Myopia > 6 diopters
  • Preoperative pseudophakia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069029


Locations
France
Ophthalmology Unit CHU Dijon
Dijon, Burgundy, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Investigators
Principal Investigator: Catherine Creuzot-Gracher, MD, PhD Ophthalmology unit CHU Dijon
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Catherine Creuzot-Garcher, Ophthalmology Department CHU Dijon
ClinicalTrials.gov Identifier: NCT01069029     History of Changes
Other Study ID Numbers: Aurore 1
First Submitted: February 16, 2010
First Posted: February 17, 2010
Last Update Posted: February 17, 2010
Last Verified: January 2006

Keywords provided by Centre Hospitalier Universitaire Dijon:
Macular Hole
Cataract surgery
Vitreoretinal surgery
Combined surgery
Idiopathic

Additional relevant MeSH terms:
Cataract
Retinal Perforations
Lens Diseases
Eye Diseases
Retinal Diseases