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

February 16, 2010
February 16, 2010
January 2006
December 2007   (final data collection date for primary outcome measure)
Post surgical procedure assessment of Visual acuity [ Time Frame: 6 and 12 months post surgery ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Rate of closure of macular hole by OCT [ Time Frame: at 6 and 12 months post surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Combined Versus Successive Macular Hole and Cataract Surgery
Macular Hole and Cataract Extraction: Combined Surgery Versus Two Times Surgery

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.

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).

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

patients with symptomatic visual loss and needed vitrectomy for Macular Hole treatment.

  • Macular Hole
  • Visual Acuity
Not Provided
  • Combined surgery
    Patient which underwent combined surgery of MH and cataract extraction
  • Successive surgery
    Patients which underwent the two successive procedures
Muselier A, Dugas B, Burelle X, Passemard M, Hubert I, Mathieu B, Berrod JP, Bron AM, Creuzot-Garcher C. Macular hole surgery and cataract extraction: combined vs consecutive surgery. Am J Ophthalmol. 2010 Sep;150(3):387-91. Epub 2010 Jul 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01069029
Aurore 1
No
Pr Catherine Creuzot-Garcher, Ophthalmology Department CHU Dijon
Centre Hospitalier Universitaire Dijon
Not Provided
Principal Investigator: Catherine Creuzot-Gracher, MD, PhD Ophthalmology unit CHU Dijon
Centre Hospitalier Universitaire Dijon
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP