Elongation of Foveal Tissue After Macular Hole Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Asymmetric Elongation of Foveal Tissue After Macular Hole Surgery and Its Impact on Metamorphopsia

Conditions
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Macular Holes

Intervention / Treatment
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* Procedure: pars plana vitrectomy and fluid gas exchange


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | first postoperative visit, 1 month, 2 months, and 6 months after macular hole surgery | 
| Changes in best-corrected visual acuity | Best-corrected visual acuity was measured using early treatment diabetic retinopathy study chart at defined time points | first postoperative visit, 2 months, and 6 months after macular hole surgery | 
| Changes in degree of metamorphopsia | The degree of metamorphopsia was measured using Metamorphopsia-chart at defined time points | first postoperative visit, 2 months, and 6 months after macular hole surgery | 
| 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. | at 6 months postoperative | 
| 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). | at 6 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular Holes, spectral domain optical coherence tomography, elongation of foveal tissue, M-score