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Elongation of Foveal Tissue After Macular Hole Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01471912
Enrollment
31
Registered
2011-11-16
Start date
2009-09-30
Completion date
2011-10-31
Last updated
2011-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Holes

Keywords

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

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.

Interventions

PROCEDUREpars 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.

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in the inter-outer plexiform layer distancefirst postoperative visit, 1 month, 2 months, and 6 months after macular hole surgerythe 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 acuityfirst postoperative visit, 2 months, and 6 months after macular hole surgeryBest-corrected visual acuity was measured using early treatment diabetic retinopathy study chart at defined time points
Changes in degree of metamorphopsiafirst postoperative visit, 2 months, and 6 months after macular hole surgeryThe degree of metamorphopsia was measured using Metamorphopsia-chart at defined time points
Degree of percent asymmetric elongation on the same planeat 6 months postoperativeThe 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 asymmetryat 6 months postoperativeThe 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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026