Clinical Trials Directory

Trials / Completed

CompletedNCT01471912

Elongation of Foveal Tissue After Macular Hole Surgery

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
31 (actual)
Sponsor
Samsung Medical Center · Academic / Other
Sex
All
Age
30 Years – 75 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREpars plana vitrectomy and fluid gas exchangeA 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.

Timeline

Start date
2009-09-01
Primary completion
2011-04-01
Completion
2011-10-01
First posted
2011-11-16
Last updated
2011-11-17

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01471912. Inclusion in this directory is not an endorsement.