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Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University
ClinicalTrials.gov Identifier:
NCT01306487
First received: March 1, 2011
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  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 Kyorin University:

Primary Outcome Measures:
  • Foveal microstructure determined by optical coherence tomography [ Time Frame: Preoperative and postoperative 1, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306487

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

No publications provided

Responsible Party: Makoto Inoue, Associate professor, Kyorin University
ClinicalTrials.gov Identifier: NCT01306487     History of Changes
Other Study ID Numbers: Kyorineye002
Study First Received: March 1, 2011
Last Updated: July 31, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyorin University:
macular hole

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013