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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University
ClinicalTrials.gov Identifier:
NCT01381965
First received: June 21, 2011
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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 Kyorin University:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: one year ] [ Designated as safety issue: No ]
    Preoperative, postoperative 1, 3, 6, 9, 12 months


Secondary Outcome Measures:
  • Integrity of cone outer segment tips line [ Time Frame: one year ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Makoto Inoue, Associate professor, Kyorin University
ClinicalTrials.gov Identifier: NCT01381965     History of Changes
Other Study ID Numbers: Kyorineye006, KYORIN-H21012
Study First Received: June 21, 2011
Last Updated: July 31, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013