Subclinical macular edema as a predictor of progression to clinically significant macular edema in type 2 diabetes

Ophthalmologica. 2013;230(4):201-6. doi: 10.1159/000354550. Epub 2013 Sep 25.

Abstract

Objective: To examine the relationship between subclinical diabetic macular edema (DME) and the development of clinically significant macular edema (CSME) in nonproliferative diabetic retinopathy (NPDR) in patients with type 2 diabetes.

Methods: A prospective, monocenter, observational study was designed to follow patients/eyes with type 2 diabetes and NPDR (Early Treatment Diabetic Retinopathy Study levels 20 and 35) with no prior laser treatment for 2 years or until development of CSME. Ophthalmologic examinations, including best-corrected visual acuity, fundus photography and optical coherence tomography (OCT), were performed at baseline, 6 months and a final visit.

Results: A total of 348 patients completed study follow-up; 26 eyes developed CSME. Six out of 32 eyes/patients presenting subclinical DME at baseline developed CSME (18.7%), while 20 out of 316 eyes without subclinical DME developed CSME (6.3%). Eyes/patients with subclinical DME presented a risk for DME progression 3.686 times higher than that of eyes/patients without subclinical DME (95% confidence interval 1.221-7.988).

Conclusions: Subclinical DME in eyes with NPDR identified by center point thickness measured on a Stratus OCT is a good predictor of CSME development.

Trial registration: ClinicalTrials.gov NCT00763802.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Blood Glucose / metabolism
  • Diabetes Mellitus, Type 2 / complications*
  • Diabetic Retinopathy / blood
  • Diabetic Retinopathy / diagnosis*
  • Disease Progression
  • Female
  • Follow-Up Studies
  • Glycated Hemoglobin A / metabolism
  • Humans
  • Lipids / blood
  • Macular Edema / blood
  • Macular Edema / diagnosis*
  • Male
  • Middle Aged
  • Prospective Studies

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Lipids
  • hemoglobin A1c protein, human

Associated data

  • ClinicalTrials.gov/NCT00763802