Fundus Autofluorescence After Vitrectomy for Epiretinal Membrane

• Sponsor: Kyorin University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02628158
• Collaborator: (none)
• Enrollment: 91
• Location: 1
• Duration (Months): 30
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Epiretinal Membrane	Procedure: Vitrectomy with internal limiting membrane removal

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 91 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Correlation of Postoperative Vision and Fundus Autofluorescence After Vitrectomy for Epiretinal Membrane
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Outcome Measures

Primary Outcome Measures

1. Visual acuity before and after surgery [Changes from baseline to 1, 3, 6 months]

   Vision

Secondary Outcome Measures

1. Presence of fluids autofluorescence at the macular area [Changes from baseline up to 6 months]

   Fundus autofluorescence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyorin Eye Center	Mitaka	Tokyo	Japan	181-8611

Sponsors and Collaborators

• Kyorin University

Investigators

• Principal Investigator: Makoto Inoue, MD, Kyorin Eye Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Makoto Inoue, Professor of Ophthalmology, Kyorin University
• ClinicalTrials.gov Identifier: NCT02628158
• Other Study ID Numbers: Kyorineye019
• First Posted: Dec 11, 2015
• Last Update Posted: Dec 11, 2015
• Last Verified: Dec 1, 2015

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Makoto Inoue, Professor of Ophthalmology, Kyorin University: Epiretinal membrane
• Additional relevant MeSH terms: Epiretinal Membrane

Study Results

No Results Posted as of Dec 11, 2015