First Prospective Cohort Study of Diabetic Retinopathy from Sub-Saharan Africa: High Incidence and Progression of Retinopathy and Relationship to Human Immunodeficiency Virus Infection.

Purpose: To describe the prevalence, incidence, and progression of retinopathy and to report associations with demographic, clinical, and biochemical variables in people with diabetes in Southern Malawi.

Design: Prospective cohort study.

Participants: Subjects were systematically sampled from 2 primary care diabetes clinics.

Methods: We performed the first prospective cohort study of diabetic retinopathy from Sub-Saharan Africa over 24 months. Visual acuity, glycemic control, blood pressure, human immunodeficiency virus (HIV) status, urine albumin-to-creatinine ratio, hemoglobin, and lipids were assessed. Retinopathy was graded at an accredited reading center using modified Wisconsin grading of 4-field mydriatic photographs.

Main Outcome Measures: Incidence of sight-threatening retinopathy and progression of retinopathy by 2 steps on the Liverpool Diabetic Eye Study Scale.

Results: A total of 357 subjects were recruited to the 24-month cohort study. At baseline, 13.4% of subjects were HIV positive and 15.1% were anemic. The 2-year incidence of sight-threatening diabetic retinopathy (STDR) for subjects with level 10 (no retinopathy), level 20 (background), and level 30 (preproliferative) retinopathy at baseline was 2.7% (95% confidence interval [CI], 0.1-5.3), 27.3% (95% CI, 16.4-38.2), and 25.0% (95% CI, 0-67.4), respectively. In a multivariate logistic analysis, 2-step progression of diabetic retinopathy was associated with glycosylated hemoglobin (odds ratio [OR], 1.27; 95% CI, 1.12-1.45), baseline grade of retinopathy (OR, 1.39; 95% CI, 1.02-1.91), and HIV infection (OR, 0.16; 95% CI, 0.03-0.78). At 2 years, 17 subjects (5.8%) lost ≥15 letters.

Conclusions: Incidence of STDR was approximately 3 times that reported in recent European studies. The negative association of HIV infection with retinopathy progression is a new finding.