Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery

Epiretinal Membrane Clinical Trial

Official title:

Evaluation of the Cone Outer Segment Tips Line After Epiretinal Membrane Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549249
• Other study ID #: KyorinEye007
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: November 12, 2012
• Start date: June 2008
• Est. completion date: November 2011

Study information

• Verified date: November 2012
• Source: Kyorin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The recovery of the cone outer segment tips (COST) line after epiretinal membrane (ERM) surgery using spectral-domain optical coherence tomography (SD-OCT) was assessed.

Description:

Epiretinal membrane (ERM) may cause decreased central vision or metamorphopsia. Pars plana vitrectomy with membrane peeling has become the standard treatment for epiretinal membrane. However, visual recovery or symptomatic relief is not always satisfactory in all eyes despite successful membrane removal. Spectral domain optical coherence tomography (SD-OCT) is a non-invasive imaging device for various vitreoretinal diseases. Cone outer segment tips (COST) line is a line observed between IS/OS line and RPE in SD-OCT. The investigators examined the correlation of visual acuity and the recovery of photoreceptor layer after ERM surgery, taking COST line into account as a new parameter

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: November 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients who received epiretinal membrane surgery between June, 2008, and November, 2010, at Kyorin Eye Center.

• Only eyes with postoperative follow-up period more than 6 months were included.

Exclusion Criteria:

• Eyes with secondary epiretinal membrane (previous history of uveitis, intraocular surgery, pre-operatively noted retinal breaks, etc.) were excluded.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epiretinal Membrane

Intervention

Device:
• optical coherence tomography
spectral-domain optical coherence tomography

Locations

Country	Name	City	State
Japan	Kyorin Eye Center	Mitaka	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyorin University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	best-corrected visual acuity		one year	No
Secondary	Integrity and defect length of the photoreceptor layer detected by spectral-domain optical coherence tomography		one year	No