Clinical Trial: Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema

Brief Summary:

This longitudinal interventional case series will utilize the patients at the University of Michigan W.K. Kellogg Eye Center scheduled to begin treatment for diabetic macular edema. Baseline measures will be taken which include structural assessments such as circulatory capacity utilizing fluorescein angiography, in addition to retinal layer integrity and thickness using high resolution optical coherence tomography. Also, functional assessments such as visual acuity, contrast sensitivity, photostress recovery, dark adaptation, perimetry, and cellular fluorescence will be tested. Adverse events will be recorded and compared with historical controls to ensure that currently accepted interventions are safe. Finally, potential confounding variables for DME including those related to the eye, systemic factors, and patient demographics will be recorded to assess the influence of these variables on treatment response.

The primary objective is to develop hypotheses that might better explain the retinal structural (anatomical) and/or functional (physiological) mechanisms of visual impairment in eyes receiving treatment for diabetic macular edema (DME).


Detailed Summary:
Sponsor: University of Michigan

Current Primary Outcome: Dark adaptation (AdaptRx) [ Time Frame: 12 Months ]

Rod intercept (minutes)


Original Primary Outcome: Same as current

Current Secondary Outcome: Optical coherence tomography [ Time Frame: 12 Months ]

Thickness of nerve fiber layer and ganglion cell layer, volume of intraretinal cysts, volume of subretinal fluid, central subfield thickness, thickness of choroid (enhanced depth imaging), status of vitreoretinal interface, presence of epiretinal membrane, status of inner segment/outer segment junction


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: March 7, 2014
Date Started: September 2012
Date Completion:
Last Updated: January 25, 2016
Last Verified: January 2016