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Clinical Trials/NCT01306487
NCT01306487
Completed
Not Applicable

Correlation Between Visual Acuity and Recovery of Foveal Cone Microstructures After Macular Hole Surgery

Kyorin University1 site in 1 country58 target enrollmentMarch 2008
ConditionsMacular Holes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Macular Holes
Sponsor
Kyorin University
Enrollment
58
Locations
1
Primary Endpoint
Foveal microstructure determined by optical coherence tomography
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
August 2010
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Makoto Inoue

Associate professor

Kyorin University

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • The visual acuity(Preoperative and postoperative 1, 3, 6, 9, 12 months)

Study Sites (1)

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