Elongation of Foveal Tissue After Macular Hole Surgery
This study has been completed.
Sponsor:
Samsung Medical Center
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
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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 |
Resource links provided by NLM:
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 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 May 16, 2013