Combined Versus Successive Macular Hole and Cataract Surgery

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. Identifier: NCT01069029
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : February 17, 2010
Information provided by:
Centre Hospitalier Universitaire Dijon

Brief Summary:
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 or disease
Macular Hole Visual Acuity

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).

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Macular Hole and Cataract Extraction: Combined Surgery Versus Two Times Surgery
Study Start Date : January 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Combined surgery
Patient which underwent combined surgery of MH and cataract extraction
Successive surgery
Patients which underwent the two successive procedures

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

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

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 identifier (NCT number): NCT01069029

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pr Catherine Creuzot-Garcher, Ophthalmology Department CHU Dijon Identifier: NCT01069029     History of Changes
Other Study ID Numbers: Aurore 1
First Posted: February 17, 2010    Key Record Dates
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

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