Evidence map›Paper›PMID 32941962›Full record

Trial reportOphthalmology2021

Refractive Error and Retinopathy Outcomes in Type 1 Diabetes: The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study.

Dean P Hainsworth, Xiaoyu Gao, Ionut Bebu, Arup Das, Lisa Olmos de Koo, Andrew J Barkmeier, William Tamborlane, John M Lachin, Lloyd Paul Aiello, Diabetes Control and Complications Trial and Follow-up Epidemiology of Diabetes Interventions and Complications Research Group

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Ophthalmology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 1 country.

Dean P HainsworthMason Eye Institute, University of Missouri, Columbia, Missouri.
Xiaoyu GaoThe Biostatistics Center, The George Washington University, Rockville, Maryland.
Ionut BebuThe Biostatistics Center, The George Washington University, Rockville, Maryland. Electronic address: ibebu@bsc.gwu.edu.
Arup DasUniversity of New Mexico School of Medicine, Albuquerque, New Mexico.
Lisa Olmos de KooUniversity of Washington, Seattle, Washington.
Andrew J BarkmeierMayo Clinic, Rochester, Minnesota.
William TamborlaneYale, New Haven, Connecticut.
John M LachinThe Biostatistics Center, The George Washington University, Rockville, Maryland.
Lloyd Paul AielloDepartment of Ophthalmology, Harvard Medical School and Beetham Eye Institute, Joslin Diabetes Center, Boston, Massachusetts.
Diabetes Control and Complications Trial and Follow-up Epidemiology of Diabetes Interventions and Complications Research Group
George Washington University · USCincinnati Eye Institute · USJoslin Diabetes Center · USMayo Clinic · USUniversity of New Mexico · USUniversity of Washington · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Limited Competition for the Continuation of Epidemiology of Diabetes Interventions and Complications (EDIC) Study Clinical Research Center (Collaborative U01)U01DK094157 · NIDDK · CASE WESTERN RESERVE UNIVERSITY · PI Ionut Bebu, Barbara Halina Braffett · 2011 to 2026
$97.6M
SPECIAL ASSAY COREP30DK036836 · NIDDK · JOSLIN DIABETES CENTER · PI ROHIT N. KULKARNI · 1986 to 2026
$50.5M
Yale Diabetes Research CenterP30DK045735 · NIDDK · YALE UNIVERSITY · PI Kevan C Herold, GERALD I SHULMAN · 1993 to 2026
$44.0M
Epidemiology of Diabetes Interventions and Complications Data Coordinating CenterU01DK094176 · NIDDK · GEORGE WASHINGTON UNIVERSITY · PI BEBU, IONUT, BRAFFETT, BARBARA HALINA · 2012 to 2022
$30.8M
NCATS NIH HHS UL1 TR001863NIDDK NIH HHS P30 DK036836NIDDK NIH HHS P30 DK045735NIDDK NIH HHS U01 DK094157NIDDK NIH HHS U01 DK094176
6 · The paper itself

Abstract

purposeTo determine the relationship between refractive error and diabetic retinopathy (DR).

designClinical trial.

participantsType I diabetes individuals with serial refractive error and DR stage measurements over 30 years in the Diabetes Control and Complications Trial (DCCT) and Epidemiology of Diabetes Interventions and Complications (EDIC) follow-up study.

methodsStage of DR was measured every 6 months from standard fundus photographs, and refractive error was measured annually during the 6.5 years of DCCT; then, both were staggered every fourth year during EDIC with the full cohort measured at EDIC years 4 and 10. Outcomes of DR were 2- or 3-step progression, presence of proliferative DR (PDR), clinically significant macular edema (CSME), diabetic macular edema (DME), or ocular surgery. Myopia, emmetropia, and hyperopia were defined as a spherical equivalent of ≤-0.5, >-0.5 and <0.5, and ≥0.5, respectively.

main outcome measuresFor each outcome separately, Cox proportional hazard (PH) models assessed the association between the refractive error status and the subsequent risk of that outcome, both without and with adjustment for potential risk factors.

resultsHyperopia was associated with a higher risk of 2-step progression (hazard ratio [HR], 1.29; 95% confidence interval [CI], 1.05-1.59), 3-step progression (HR, 1.35; 95% CI, 1.05-1.73), and PDR (HR, 1.40; 95% CI, 1.02-1.92) compared with emmetropia in unadjusted models. These associations remained significant after adjustment for DCCT treatment group, cohort, age, sex, smoking, duration of diabetes, systolic and diastolic blood pressures, pulse, low-density lipoprotein, high-density lipoprotein, triglycerides, albumin excretion rate, and DCCT/EDIC mean updated hemoglobin A1c (HbA1c) (2-step progression: HR, 1.28; 95% CI, 1.03-1.58; 3-step progression: HR, 1.30; 95% CI, 1.00-1.68; PDR: HR, 1.38; 95% CI, 1.00-1.90). Myopia was not associated with any of the 5 DR outcomes in the unadjusted models and only marginally associated with 2-step progression (HR, 1.11; 95% CI, 1.00-1.24) in the adjusted models.

conclusionsMyopia is not associated with DR progression risk. Hyperopia is an independent risk factor for 2-step and 3-step DR progression and PDR.

Indexed as

AdultBlood GlucoseBlood PressureDiabetes Mellitus, Type 1Diabetic RetinopathyDisease ProgressionFemaleFollow-Up StudiesGlycated HemoglobinHumansHyperopiaMacular EdemaMaleMiddle AgedMyopiaProportional Hazards ModelsBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanDCCT/EDICDiabetes mellitusDiabetic retinopathyRefractive error

Identifiers

PMID32941962
PMCPMC7956062
OpenAlexW3086673171

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.