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Combined Versus Successive Macular Hole and Cataract Surgery

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01069029
First received: February 16, 2010
Last updated: NA
Last verified: January 2006
History: No changes posted
  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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of closure of macular hole by OCT [ Time Frame: at 6 and 12 months post surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Centre Hospitalier Universitaire Dijon

Additional 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
Study First Received: February 16, 2010
Last Updated: February 16, 2010
Health Authority: France: Direction Générale de la Santé

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

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

ClinicalTrials.gov processed this record on May 19, 2013