Back to resultsElongation of Foveal Tissue After Macular Hole Surgery
Primary Purpose
Macular Holes
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pars plana vitrectomy and fluid gas exchange
Sponsored by
About this trial
This is an interventional diagnostic trial for Macular Holes focused on measuring Macular Holes, spectral domain optical coherence tomography, elongation of foveal tissue, M-score
Eligibility 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
Sites / Locations
- Samsung Medical Center
Outcomes
Primary Outcome Measures
Changes in the inter-outer plexiform layer distance
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
Best-corrected visual acuity was measured using early treatment diabetic retinopathy study chart at defined time points
Changes in degree of metamorphopsia
The degree of metamorphopsia was measured using Metamorphopsia-chart at defined time points
Degree of percent asymmetric elongation on the same plane
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
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01471912
First Posted
November 6, 2011
Last Updated
November 16, 2011
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01471912
Brief Title
Elongation of Foveal Tissue After Macular Hole Surgery
Official Title
Asymmetric Elongation of Foveal Tissue After Macular Hole Surgery and Its Impact on Metamorphopsia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes
Keywords
Macular Holes, spectral domain optical coherence tomography, elongation of foveal tissue, M-score
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
pars plana vitrectomy and fluid gas exchange
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the inter-outer plexiform layer distance
Description
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
Time Frame
first postoperative visit, 1 month, 2 months, and 6 months after macular hole surgery
Title
Changes in best-corrected visual acuity
Description
Best-corrected visual acuity was measured using early treatment diabetic retinopathy study chart at defined time points
Time Frame
first postoperative visit, 2 months, and 6 months after macular hole surgery
Title
Changes in degree of metamorphopsia
Description
The degree of metamorphopsia was measured using Metamorphopsia-chart at defined time points
Time Frame
first postoperative visit, 2 months, and 6 months after macular hole surgery
Title
Degree of percent asymmetric elongation on the same plane
Description
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.
Time Frame
at 6 months postoperative
Title
Degree of horizontal-vertical percent asymmetry
Description
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).
Time Frame
at 6 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Elongation of Foveal Tissue After Macular Hole Surgery
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