Elongation of Foveal Tissue After Macular Hole Surgery

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01471912
Collaborator
(none)
31
1
25
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: pars plana vitrectomy and fluid gas exchange
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
N/A
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
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Outcome Measures

Primary Outcome Measures

  1. Changes in the inter-outer plexiform layer distance [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

  2. Changes in best-corrected visual acuity [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

  3. Changes in degree of metamorphopsia [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

  4. Degree of percent asymmetric elongation on the same plane [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.

  5. Degree of horizontal-vertical percent asymmetry [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of 135-710

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01471912
Other Study ID Numbers:
  • 2011-10-003
First Posted:
Nov 16, 2011
Last Update Posted:
Nov 17, 2011
Last Verified:
Nov 1, 2011
Keywords provided by Samsung Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2011