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
  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: 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 ] [ 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).


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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01471912

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

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01471912     History of Changes
Other Study ID Numbers: 2011-10-003
Study First Received: November 6, 2011
Last Updated: November 16, 2011
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014