Elongation of Foveal Tissue After Macular Hole Surgery

Macular Holes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471912
• Other study ID #: 2011-10-003
• 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

• Macular Holes
• Retinal Perforations

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