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Completed

NCT Number: NCT01471912

Elongation of Foveal Tissue After Macular Hole Surgery

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.

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Key information

Conditions

Macular Holes Eye Diseases Retinal Diseases Retinal Perforations

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 16, 2011
Registry last updated
Nov 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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