Fundus Autofluorescence After Vitrectomy for Epiretinal Membrane

Epiretinal Membrane Clinical Trial

Official title:

Correlation of Postoperative Vision and Fundus Autofluorescence After Vitrectomy for Epiretinal Membrane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628158
• Other study ID #: Kyorineye019
• Status: Completed
• Phase: N/A
• First received: December 6, 2015
• Last updated: December 8, 2015
• Start date: April 2013
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Kyorin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Fundus autofluorescence (FAF) at the macula originates from hyperfluorescence from retinal pigment epithelium (RPE) and blockage of hyperfluorescence by macular pigment. Investigators evaluate whether presence of FAF may correlate to the postoperative visual outcome for epiretinal membrane.

Description:

92 eyes with epiretinal membrane were performed vitreous surgery, epiretinal membrane removal and internal limiting membrane (ILM) peeling. Presence of hyperfluorescence in FAF at the macular area and best-corrected visual acuity (BCVA) was evaluated preoperatively and at postoperative 1, 3, and 6 months with ultra-wide angle imaging.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: October 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane removal for epiretinal membrane and had followed for more than 6 months.

Exclusion Criteria:

• The patients with follow-up less than 6 months.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Epiretinal Membrane

Intervention

Procedure:
• Vitrectomy with internal limiting membrane removal
Vitrectomy with removal of epiretinal membrane and internal limiting membrane

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	Visual acuity before and after surgery	Vision	Changes from baseline to 1, 3, 6 months	No
Secondary	Presence of fluids autofluorescence at the macular area	Fundus autofluorescence	Changes from baseline up to 6 months	No