Combined Versus Successive Macular Hole and Cataract Surgery

February 16, 2010 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Burgundy
      • Dijon, Burgundy, France, 21000
        • Ophthalmology Unit CHU Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post surgical procedure assessment of Visual acuity
Time Frame: 6 and 12 months post surgery
6 and 12 months post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of closure of macular hole by OCT
Time Frame: at 6 and 12 months post surgery
at 6 and 12 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Investigators

  • Principal Investigator: Catherine Creuzot-Gracher, MD, PhD, Ophthalmology Unit CHU Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

February 17, 2010

Last Update Submitted That Met QC Criteria

February 16, 2010

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aurore 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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