Ultra-Widefield and Early Treatment Diabetic Retinopathy Study 7-Field Grading of Diabetic Retinopathy
Authors: Aiello Lloyd Paul , Blodi Barbara , Gao Xiaoyu , Sun Jennifer K. , Gubitosi-Klug Rose A. , White Neil H. , Hainsworth Dean , Lorenzi Gayle M. , Bebu Ionut ,   DCCT/EDIC Research Group, Adkins T. , Agarwal Anita , Aiello Lloyd P , Albers James W , Arends Valerie , Arrigg Paul , Averkiou Xenia , Avery Robert B , Azevedo Robin , Backlund Jye-Yu , Bakshi N. , Bancroft Anna P , Bantle Anne , Bantle John , Barkmeier Andrew , Barnie Annette , Barr M. , Bartholomew Rachel , Beaser Richard , Bebu Ionut , Bergenstal Richard , Bhan Arti , Blodi Barbara , Bott Matthew , Bourne Patti A , Braffett Barbara H , Brent M. , Brown Angela , Brucker Alexander J , Burge Mark R , Bylsma Jillian , Campbell Charles , Carlson Anders , Cavallerano Jerry , Cavicchi Robert , Chan R. , Chapin J.E. , Chu Kathy , Coonrod Beth A , Costacou Tina , Dagogo-Jack Samuel , Danis Ron , Das Arup , Devenyi Robert , Diminick Lisa , Driscoll Marsha , Dunnigan Sean , Edwards Paul , El Muayed Malek , El ghormli Laure , Farrell Kaleigh , Feldman Eva , Fernandes Jyotika , Ganda Om , Gao Xiaoyu , Gatcomb Patricia M , Gill Manjot , Goldbaum Michael , Golden Ellen , Greanoff Gregg , Gregory Naina S , Gubitosi-Klug Rose A , Hainsworth Dean , Hamdy Osama , Hanna Regina , Hartmuller Monica , He Yu-Guang , Heier Jeffrey , Hensley S. , Herman William , Hermayer Kathie L , Hirsch Irl , Hitt Susan , Ho Shuchen , Hoffman Elizabeth , Hu J. , Huddleston S. , Jacobson Alan M , Jarvis Alan , Johnson Mary L , Johnsonbaugh Sherry , Jones J.K. , Jordan Lin F , Joseph A. , Karanchi Harsha , Karger Amy , Keasler Lisa , Kenny David , Ketai Loren H , Kiss Szilard , Klumpp Kandy , Kolterman Orville , Koozekanani Dara , Koushan Keyvan , Kruger Davida F , Lachin John , Larkin Mary , Lawrence Jean , Lee K. , Lee Pearl G , Leong Aaron , Leschek Ellen , Li Yabing , Lin Ming-Hui , Lorenzi Gayle , Lovell Cynthia K , Lyon Alice T , Lyons Tim J , Malone John I , Mandelcorn Mark , Marksbury Tiffanie , Martin Catherine , May Michael , Mayer Lynne , McDonald Charlotte , Mendelson Edward , Miller David , Miller Ryan , Mirza Rukhsana G , Montezuma Sandra R , Morrison Anthony , Mudaliar Sunder , Mukhashen Shereen , Murtha Timothy J , Nathan David M , Novak M. , Nutaitis Matthew J , Olegario Donna , Olmos de Koo Lisa , Orchard Trevor , Orlin Anton , O’Brian Juanita , Pavan Peter R , Pendegast S. , Perdikaris F. , Perkins Bruce A , Pop-Busui Rodica , Raskin Philip , Rath S. , Rhodes Melissa , Rodriguez Henry , Rubin Michael , Ryan Christopher , Saporito Deborah , Saporito Madalyn , Schade David S , Schlossman Deborah K , Schutta Mark H , Seegmiller Jesse , Shah Ravi , Shao Baomei , Sharuk George S , Sheidow Tom , Sherr Jennifer , Silva Paolo A , Silver Philip , Singerman Lawrence J , Sivitz William , Soliman Elsayed Z , Spillers Lori , Steffes Michael , Stockman Margaret E , Stoessel Kathleen , Sun Jennifer , Tamborlane William , Taylor Trevor , Terry J. , Thangthaeng Nopporn , Thomas Lee A , Toledo Frederico , Trapani Victoria , Ufret-Vincenty Rafael L , Vella Adrian , Vittetoe Brenda , Wabers Hugh , Wallia Amisha , Weimann Elizabeth , Weiss D. , White Neil , Wilson Rachael , Wood Jamie , Zegarra H. , Zhang Zhu-Ming , Zipse Amy , de Boer Ian H 
Published: August 2024

Importance

High concordance in diabetic retinopathy (DR) outcomes between 7-field (7F) and ultra-widefield (UWF) images would allow for combining longitudinal assessments based on the 2 modalities both in clinical studies and clinical care.

Objective

To compare 7F and UWF imaging with regard to DR severity and the associations of DR severity with risk factors, such as hemoglobin A1c, age, diabetes duration, and sex.

Design, Setting, and Participants

This cross-sectional study describes the outcomes of the randomized clinical Diabetes Control and Complications Trial (DCCT) and its subsequent observational study, the Epidemiology of Diabetes Interventions and Complications (EDIC) study. Of the 1441 participants with type 1 diabetes in the DCCT, 1375 were enrolled in the EDIC study. Of the 1171 participants who were active between March 2019 and December 2021, 200° UWF color imaging and 7F fundus photographs were obtained for 785 participants once at the same visit. Central graders assessed 7F-UWF with a 7F template masking the retinal periphery and the full UWF image (UWF-global). Data were analyzed from January 2022 to March 2023.

Exposures

Hemoglobin A1c was assessed quarterly during the DCCT and annually during the EDIC study using high-performance liquid chromatography.

Main Outcomes and Measures

Retinopathy was determined independently for all imaging as mild, moderate, or severe nonproliferative DR (SNPDR) using the Early Treatment Diabetic Retinopathy Study (ETDRS) grading scale for the 7F images and the global ETDRS grading scale for the UWF images. Panretinal and focal photocoagulation were self-reported or based on scarring location and pattern observed during grading. Proliferative DR (PDR) was defined by observed neovascularization or evidence of panretinal photocoagulation.

Results

Among the 785 participants included in this study, 420 (53%) were male and 365 (47%) were female. The mean (SD) age was 61 (7) years. DR grading between UWF-7F and 7F imaging was correlated for all outcomes, including for severe outcomes, such as SNPDR (κ, 0.73; concordance, 96%), PDR (κ, 0.74; concordance, 97%), scatter photocoagulation (κ, 0.97; concordance, 99%), and focal photocoagulation (κ, 0.71; concordance, 98%). Most DR severity scores were within 1 step (1410 of 1529 [92%]), and 3% (51 of 1529) were more than 2 steps apart (κ, 0.45; 95% CI, 0.42-0.49; weighted κ, 0.63; 95% CI, 0.60-0.67) on the ETDRS severity scale. DR severity assessed within the UWF-global area was higher compared to 7F (median [IQR] UWF-global score, 3 [2-3] vs median 7F level score, 2.0 [1-3]; P &amp;lt; .001), although the 2 modalities were correlated (1225 of 1508 [81%] 1-step agreement; weighted κ, 0.41).

Conclusions and Relevance

Standard ETDRS 7F and UWF evaluations of DR were comparable for ETDRS severity levels as previously reported by Diabetic Retinopathy Clinical Research Retina Network reports. In addition, these evaluations of DR were comparable for DCCT/EDIT study outcomes and major study conclusions, suggesting that use of UWF imaging is not likely to introduce relevant measurement biases in future longitudinal studies.

Trial Registration

ClinicalTrials.gov Identifiers: NCT00360815