Elongation of Foveal Tissue After Macular Hole Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Macular Holes
• Intervention / Treatment: Procedure: pars plana vitrectomy and fluid gas exchange

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: November 6, 2011
• First Submitted That Met QC Criteria: November 10, 2011
• First Posted (Estimate): November 16, 2011

Study Record Updates

• Last Update Posted (Estimate): November 17, 2011
• Last Update Submitted That Met QC Criteria: November 16, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: spectral domain optical coherence tomography; Macular Holes; elongation of foveal tissue; M-score
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: 2011-10-003