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

Tracking Information
First Received Date ^ICMJE	March 1, 2011
Last Updated Date	July 31, 2012
Start Date ^ICMJE	March 2008
Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 1, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01306487 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 1, 2011)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery
Official Title ^ICMJE	Correlation Between Visual Acuity and Recovery of Foveal Cone Microstructures After Macular Hole Surgery
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Consecutive patients with surgically-closed MHs after successful vitrectomy
Condition ^ICMJE	Macular Holes
Intervention ^ICMJE	Procedure: Vitrectomy Macular hole surgery Other Name: Optical coherence tomography
Study Group/Cohort (s)	Macular hole patients The patients who underwent vitreous surgery for idiopathic macular hole. Intervention: Procedure: Vitrectomy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	58
Completion Date	August 2010
Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01306487
Other Study ID Numbers ^ICMJE	Kyorineye002
Has Data Monitoring Committee	No
Responsible Party	Makoto Inoue, Kyorin University
Study Sponsor ^ICMJE	Kyorin University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Kyorin University
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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