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Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01381965
First Posted: June 27, 2011
Last Update Posted: August 2, 2012
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 (Responsible Party):
Makoto Inoue, Kyorin University
  Purpose
Spectral domain optical coherence tomography (SD-OCT) was used to determine whether the repair of photoreceptor cone outer segment tips defect is significantly correlated with the visual outcomes after macular hole surgery.

Condition Intervention
Macular Holes Procedure: Vitreous surgery for macular hole

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery

Further study details as provided by Makoto Inoue, Kyorin University:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: one year ]
    Preoperative, postoperative 1, 3, 6, 9, 12 months


Secondary Outcome Measures:
  • Integrity of cone outer segment tips line [ Time Frame: one year ]
    The mean length of cone outer segment tips defect on preoperative and postoperative 1, 3, 6, 9, and 12 months with spectral domain optical coherence tomography


Enrollment: 72
Study Start Date: March 2008
Study Completion Date: February 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Eyes with macular hole Procedure: Vitreous surgery for macular hole
Vitreous surgery for macular hole

Detailed Description:
Spectral domain optical coherence tomography (SD-OCT) was used to calculate the mean length of photoreceptor cone outer segment tips (COST) defect on 1, 3, 6, 9, and 12 months after macular hole surgery. The correlation between the mean length of COST defect and the BCVA was determined. Prognostic factors might have influenced for COST repair was also evaluated by multivariable analysis.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • macular hole patients with surgically-closed hole

Exclusion Criteria:

  • macular hole patients failed to close hole
  • presence of retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy, and high myopia with an axial length >27.0mm or refractive error > -8.0 diopters(D).
  • patients who were not followed at least 6 months
  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): NCT01381965


Locations
Japan
Makoto Inoue
Mitaka, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Kyorin University
Investigators
Principal Investigator: Makoto Inoue, MD Kyorin Eye Center
  More Information

Responsible Party: Makoto Inoue, Associate professor, Kyorin University
ClinicalTrials.gov Identifier: NCT01381965     History of Changes
Other Study ID Numbers: Kyorineye006
KYORIN-H21012 ( Other Identifier: Kyorin University )
First Submitted: June 21, 2011
First Posted: June 27, 2011
Last Update Posted: August 2, 2012
Last Verified: July 2012

Keywords provided by Makoto Inoue, Kyorin University:
spectral-domain optical coherence tomography
idiopathic macular hole
cone outer segment tips line
vitrectomy

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases