Elongation of Foveal Tissue After Macular Hole Surgery

NCT01471912 | Completed

• 1 other identifier: 2011-10-003
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Holes

Keywords

Macular Holes; spectral domain optical coherence tomography; elongation of foveal tissue; M-score

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

pars plana vitrectomy and fluid gas exchange PROCEDURE

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 Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were diagnosed with idiopathic macular hole

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2011
• First Posted: November 16, 2011
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 17, 2011

Record last verified: 2011-11

Locations

KR (1)