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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01471912
Other study ID # 2011-10-003
Secondary ID
Status Completed
Phase N/A
First received November 6, 2011
Last updated November 16, 2011
Start date September 2009
Est. completion date October 2011

Study information

Verified date November 2011
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date October 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 75 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
pars 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.

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
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