standard vs ultrawide-field fundus photographs in...

The Diabetic Retinopathy

Clinical Research Network

Standard vs Ultrawide-field Fundus

Photographs in the Management

of Diabetic Retinopathy

Supported through a cooperative agreement from the National Eye Institute and the National Institute of Diabetes and Digestive and

Kidney Diseases, National Institutes of Health, Department of Health and Human Services EY14231, EY14229, EY018817

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Standard Fundus Photographs Commonly used,

validated protocols for

digital images for DR

and DME include

• Modified ETDRS 7-field

stereoscopic digital

photos (30° or 35°)

• 4-field wide angle

stereoscopic digital

photos (45° to 60°)

2 Photographs from http://eyephoto.ophth.wisc.edu Gangaputra S, et al. Invest Ophthalmol Vis Sci. 2011;52(9):6168-73.

Disadvantages of current methods

• Need pupillary dilation

• Up to 16 or more flashes per eye

• Extensive training and certification of imagers

• Combined 7 standard fields cover <100° of

retina- peripheral lesions may be missed

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Standard Fundus Photographs

Ultrawide-field Retinal Imaging Options Retcam

• Contact lens based system with up to 130° field

Staurenghi lens

• SLO compatible contact lens

• Up to 150° field

Heidelberg system

• Noncontact, widefield lens snaps onto camera head

Optos system • Noncontact SLO technology scans simultaneously with green

and red laser wavelengths

• 100º and 200º fields

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200º versus ETDRS 7 Std Fields

NVE >1/2

Disc Area

Do Ultrawide Fields Case 1: Retinal Pathology in the

ETDRS 7 Standard Fields

NVE >1/2

Disc Area

Case 1: Identification of Additional

Retinal Pathology on UWF Image

Case 1: Follow-up after 2 Years

Identification of Additional Retinal

Pathology on UWF Image Case 2: Retinal Pathology in the

ETDRS 7 Standard Fields

NVE <1/2

Disc Area

HMA >2A

IRMA >8A

HMA >2A

Case 2: Identification of Additional

Retinal Pathology on UWF Image

Case 2: Follow-up after 2 Years

Do peripheral lesions predict future

progression of DR over time?

Ultrawide Field Study Rationale If peripheral DR lesions improve our ability to

predict DR worsening or improvement, this

could:

• Change patient management: evaluation and

follow-up

• Give new insights into mechanisms for

changes in retinal pathology

• Allow fewer images leading to faster imaging

time and greater patient comfort 12

Objectives

Primary objective

• To assess whether presence or severity of

hallmark DR lesions located outside the

standard ETDRS fields on ultrawide-field

(UWF) images is associated with increased

rates of DR or DME worsening or

improvement over time

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Study Design Prospective, observational longitudinal study

Enrollment criteria

• Adults with diabetes with a wide range of DR and DME

severity.

• Eyes that have not previously received treatment with

intravitreal agents over the prior 12 months and

treatment is not anticipated for the next 6 months

• Non-proliferative diabetic retinopathy (ETDRS level

>35, < 60) based on modified 7 field ETDRS grading.

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Study Design

Follow-up: Annually for 3-5 years

Study procedures:

• Baseline and Annual Visits

o Best corrected VA and eye exam

o UWF images

o DRCR.net 7 std field protocol images

o SD OCT

o BP and HbA1c 15

Expected Major Study Outcomes

Cross Sectional Analysis at Baseline

• Level of agreement between DR or DME severity as

graded on UWF vs DRCR.net protocol images

Longitudinal Analysis

• Association between additional peripheral lesions

identified on UWF not within the ETDRS 7 std fields

and rate of DR worsening or improvement

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Thank You on Behalf of Diabetic Retinopathy

Clinical Research Network (DRCR.net)

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