Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2009-09-30
2011-10-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
30 Years
75 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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2011-10-003
Identifier Type: -
Identifier Source: org_study_id