Elongation of Foveal Tissue After Macular Hole Surgery
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|ClinicalTrials.gov Identifier: NCT01471912|
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : November 17, 2011
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|
|Macular Holes||Procedure: pars plana vitrectomy and fluid gas exchange||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Asymmetric Elongation of Foveal Tissue After Macular Hole Surgery and Its Impact on Metamorphopsia|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||October 2011|
Procedure: pars plana vitrectomy and fluid gas exchange
- 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).
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
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|