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Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01306487
First Posted: March 2, 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
The objective is to determine whether a recovery of the microstructures of the foveal photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual acuity (BCVA) is determined.

Condition Intervention
Macular Holes Procedure: Vitrectomy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Correlation Between Visual Acuity and Recovery of Foveal Cone Microstructures After Macular Hole Surgery

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

Primary Outcome Measures:
  • Foveal microstructure determined by optical coherence tomography [ Time Frame: Preoperative and postoperative 1, 3, 6, 9, 12 months ]
    The integrity of the microstructures of the foveal photoreceptors; the inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined by spectral domain optical coherence tomography.


Secondary Outcome Measures:
  • The visual acuity [ Time Frame: Preoperative and postoperative 1, 3, 6, 9, 12 months ]
    Preoperative and postoperative best-corrected visual acuity


Enrollment: 58
Study Start Date: March 2008
Study Completion Date: August 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Macular hole patients
The patients who underwent vitreous surgery for idiopathic macular hole.
Procedure: Vitrectomy
Macular hole surgery
Other Name: Optical coherence tomography

Detailed Description:
Macular hole patients were evaluated by spectral domain optical coherence tomography (SD-OCT) to determine the integrity of the microstructures of the foveal photoreceptors. The inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined preoperatively, and at 1, 3, 6, 9, and 12 months after the MH surgery. The correlation between the integrity of the foveal photoreceptor microstructures and the best-corrected visual acuity (BCVA) was determined.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients with surgically-closed MHs after successful vitrectomy
Criteria

Inclusion Criteria:

  • The patients had undergone surgery from March 2008 to August 2009 at Kyorin Eye Center
  • Idiopathic macular hole patients with either a Stage 2, 3, or 4 according to the Gass classification

Exclusion Criteria:

  • The presence of other retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy
  • High myopia with an axial length > 27.0 mm or refractive error > -8.0 diopters
  • The patients followed for less than 6 months postoperatively
  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): NCT01306487


Locations
Japan
Kyorin Eye Center
Mitaka, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Kyorin University
  More Information

Responsible Party: Makoto Inoue, Associate professor, Kyorin University
ClinicalTrials.gov Identifier: NCT01306487     History of Changes
Other Study ID Numbers: Kyorineye002
First Submitted: March 1, 2011
First Posted: March 2, 2011
Last Update Posted: August 2, 2012
Last Verified: July 2012

Keywords provided by Makoto Inoue, Kyorin University:
macular hole

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases