Elongation of Foveal Tissue After Macular Hole Surgery

Not Applicable

Completed

• Conditions: Macular Holes

• Registration Number: NCT01471912
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-04
• Study Completion: 2011-10
• Status Verified: 2011-11
• Study First Submitted: 2011-11-06
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-16
• Last Update Submitted: 2011-11-16
• Last Update Posted: 2011-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
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
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
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.
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).

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of