Elongation of Foveal Tissue After Macular Hole Surgery

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01471912

First received: November 6, 2011

Last updated: November 16, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	November 6, 2011
Last Updated Date	November 16, 2011
Start Date ^ICMJE	September 2009
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 10, 2011)	Changes in the inter-outer plexiform layer distance [ Time Frame: first postoperative visit, 1 month, 2 months, and 6 months after macular hole surgery ] [ Designated as safety issue: No ] the spectral domain optical coherence tomography scannings were performed at first postoperative visit, 1 month, 2 months, and 6 months after macular hole surgery. The inter-outer plexiform layer distance was measured based on optical coherence tomography images at defined time points Changes in best-corrected visual acuity [ Time Frame: first postoperative visit, 2 months, and 6 months after macular hole surgery ] [ Designated as safety issue: No ] Best-corrected visual acuity was measured using early treatment diabetic retinopathy study chart at defined time points Changes in degree of metamorphopsia [ Time Frame: first postoperative visit, 2 months, and 6 months after macular hole surgery ] [ Designated as safety issue: No ] The degree of metamorphopsia was measured using Metamorphopsia-chart at defined time points Degree of percent asymmetric elongation on the same plane [ Time Frame: at 6 months postoperative ] [ Designated as safety issue: No ] The horizontal percent asymmetry was calculated as (nasal distance - temporal distance)/(nasal distance + temporal distance). The vertical percent asymmetry was also calculated as (superior distance - inferior distance)/ (superior distance + inferior distance. Degree of horizontal-vertical percent asymmetry [ Time Frame: at 6 months postoperative ] [ Designated as safety issue: No ] The percent asymmetry was calculated as (horizontal inter-outer plexiform layer distance - vertical inter-outer plexiform layer distance)/(horizontal inter-outer plexiform layer distance + vertical inter-outer plexiform layer distance).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01471912 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Elongation of Foveal Tissue After Macular Hole Surgery
Official Title ^ICMJE	Asymmetric Elongation of Foveal Tissue After Macular Hole Surgery and Its Impact on Metamorphopsia
Brief Summary	In our experience, elongation of foveal tissue after macular hole surgery which was undetectable by conventional time-domain optical coherence tomography was often observed on spectral-domain optical coherence tomography images. Elongation of tissues inevitably induces some degree of disorganization of tissue microstructure. The purpose of the present study was to evaluate elongation profile of foveal tissue after macular hole surgery and to investigate its impact on visual acuity and metamorphopsia.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Macular Holes
Intervention ^ICMJE	Procedure: pars plana vitrectomy and fluid gas exchange A three-port standard pars plana vitrectomy was performed by a single surgeon using a 23-gauge vitrectomy system, either Associate®(Dutch Ophthalmic Research Center. Inc., Zuidland, The Netherlands) or Accurus®(Alcon Laboratories Inc., Fort Worth, USA), with one step scleral tunnel incision. In all cases, the peeling of the internal limiting membrane, approximately 1 disc diameter area from center of MH was conducted without assistance of dyes followed by complete fluid-gas exchange using 25% sulfur hexafluoride gas. Combined cataract surgery was performed in patients with visually significant cataracts or with incipient cataract in the subjects older than 60 years. All patients were instructed to maintain a face-down position for at least 7 days postoperatively.
Study Arm (s)	Not Provided
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	31
Completion Date	October 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients who were diagnosed with idiopathic macular hole Exclusion Criteria: traumatic macular hole evidence of ocular inflammation, diabetic retinopathy, hypertensive retinopathy, and retinal vasculitis, media opacity that would influence visual acuity or preclude acquisition of clear spectral domain optical coherence tomography images presence of cataract judged to affect visual function, -6.0 diopters or more of spherical equivalent, prominent staphyloma history of intraocular surgery other than uncomplicated cataract surgery, other ocular diseases that may influence the macular microstructure or visual function patients with indistinct intraretinal structure on spectral domain optical coherence tomography images
Gender	Both
Ages	30 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01471912
Other Study ID Numbers ^ICMJE	2011-10-003
Has Data Monitoring Committee	No
Responsible Party	Samsung Medical Center
Study Sponsor ^ICMJE	Samsung Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Samsung Medical Center
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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