Evidence map›Paper›PMID 20212201›Full record

Trial reportArchives of ophthalmology (Chicago, Ill. : 1960)2010

Lack of association between thiazolidinediones and macular edema in type 2 diabetes: the ACCORD eye substudy.

Walter T Ambrosius, Ronald P Danis, David C Goff, Craig M Greven, Hertzel C Gerstein, Robert M Cohen, Matthew C Riddle, Michael E Miller, John B Buse, Denise E Bonds and 8 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Archives of ophthalmology (Chicago, Ill. : 1960), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00542178. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
6.8field-weighted citation impact, top 3% 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.

NCT00542178 phase3completed

Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study

Ran2003Enrolled3,472Registered outcomes4Posted comparisons12ConditionsDiabetic RetinopathyArmsFenofibrate, Hypoglycemic Agents, Intensive BP treatment, Placebo, simvastatin
PMID 20587587PMID 17599420other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Blood pressure control for diabetic retinopathy.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Blood pressure control for diabetic retinopathy.The Cochrane database of systematic reviews · 2015
    Pooled it
  3. Trial
  4. Choroidal Thickening Induced by Pioglitazone in Diabetic Patients.Korean journal of ophthalmology : KJO · 2024
    Article
  5. Effects of newer-generation anti-diabetics on diabetic retinopathy: a critical review.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Diabetic macular edema: Evidence-based management.Indian journal of ophthalmology · 2018
    Review
  14. Review
  15. Review
  16. Sight-threatening diabetic eye disease: an update and review of the literature.The British journal of general practice : the journal of the Royal College of General Practitioners · 2014
    Review
  17. Article
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 1 institution in 1 country.

Walter T AmbrosiusDepartment of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest University Health Sciences, Medical Center Boulevard, Winston-Salem, NC 27157, USA. wambrosi@wfubmc.edu
Ronald P Danis
David C Goff
Craig M Greven
Hertzel C Gerstein
Robert M Cohen
Matthew C Riddle
Michael E Miller
John B Buse
Denise E Bonds
Kevin A Peterson
Yves D Rosenberg
Letitia H Perdue
Barbara A Esser
Lea A Seaquist
James V Felicetta
Emily Y Chew
ACCORD Study Group
Wake Forest University · US

Funding

ACCORD (Action to Control Cardiovascular Risk in Diabetes)ZIAEY000410 · NEI · NATIONAL EYE INSTITUTE · PI CHEW, EMILY Y · 2009 to 2025
$639k
Intramural NIH HHS ZIA EY000410
6 · The paper itself

Abstract

objectiveTo assess the cross-sectional association of thiazolidinediones with diabetic macular edema (DME).

methodsThe cross-sectional association of DME and visual acuity with thiazolidinediones was examined by means of baseline fundus photographs and visual acuity measurements from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Visual acuity was assessed in 9690 participants in the ACCORD trial, and 3473 of these participants had fundus photographs that were centrally read in a standardized fashion by masked graders to assess DME and retinopathy from October 23, 2003, to March 10, 2006.

resultsAmong the subsample, 695 (20.0%) people had used thiazolidinediones, whereas 217 (6.2%) people had DME. Thiazolidinedione use was not associated with DME in unadjusted (odds ratio [OR], 1.01; 95% confidence interval [CI], 0.71-1.44; P = .95) and adjusted (OR, 0.97; 95% CI, 0.67-1.40; P = .86) analyses. Significant associations with DME were found for retinopathy severity (P < .001) and age (OR, 0.97; 95% CI, 0.952-0.997; P = .03) but not for hemoglobin A(1c) (P = .06), duration of diabetes (P = .65), sex (P = .72), and ethnicity (P = .20). Thiazolidinedione use was associated with slightly greater visual acuity (0.79 letter; 95% CI, 0.20-1.38; P = .009) of uncertain clinical significance.

conclusionsIn a cross-sectional analysis of data from the largest study to date, no association was observed between thiazolidinedione exposure and DME in patients with type 2 diabetes; however, we cannot exclude a modest protective or harmful association. Trial Registration clinicaltrials.gov Identifier: NCT00542178.

Indexed as

Cross-Sectional StudiesDiabetes Mellitus, Type 2Diabetic RetinopathyDouble-Blind MethodFemaleFollow-Up StudiesHumansHypoglycemic AgentsIncidenceLigandsMacular EdemaMaleMiddle AgedOdds RatioThiazolidinedionesVisual Acuity2,4-thiazolidinedioneHypoglycemic AgentsLigandsThiazolidinediones

Identifiers

PMID20212201
PMCPMC3010554
OpenAlexW2161752601

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.