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Elongation of Foveal Tissue After Macular Hole Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01471912
First Posted: November 16, 2011
Last Update Posted: November 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Samsung Medical Center
  Purpose

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.


Condition Intervention
Macular Holes Procedure: pars plana vitrectomy and fluid gas exchange

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Asymmetric Elongation of Foveal Tissue After Macular Hole Surgery and Its Impact on Metamorphopsia

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Changes in the inter-outer plexiform layer distance [ Time Frame: first postoperative visit, 1 month, 2 months, and 6 months after macular hole surgery ]
    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 ]
    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 ]
    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 ]
    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 ]
    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).


Enrollment: 31
Study Start Date: September 2009
Study Completion Date: October 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471912


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01471912     History of Changes
Other Study ID Numbers: 2011-10-003
First Submitted: November 6, 2011
First Posted: November 16, 2011
Last Update Posted: November 17, 2011
Last Verified: November 2011

Keywords provided by Samsung Medical Center:
Macular Holes
spectral domain optical coherence tomography
elongation of foveal tissue
M-score

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases