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Completed

NCT Number: NCT01306487

Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery

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.

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Key information

Conditions

Macular Holes Eye Diseases Retinal Diseases Retinal Perforations

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyorin Eye Center

Mitaka, Tokyo, 181-8611, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitrectomy

Procedure

Macular hole surgery

Other names: Optical coherence tomography

Primary outcomes

  1. 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

  1. The visual acuity

    Time frame: Preoperative and postoperative 1, 3, 6, 9, 12 months

    Preoperative and postoperative best-corrected visual acuity

Sponsors and collaborators

Lead sponsor

Kyorin University

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Mar 2, 2011
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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