The Chronic Care for Wet Age Related Macular Degeneration (CHARMED) Study: A Randomized Controlled Trial

Abstract

Background: In real life, outcomes in wet age related macular degeneration (W-AMD) continue to fall behind the results from randomized controlled trials. The aim of this trial was to assess if outcomes can be improved by an intervention in healthcare organization following recommendations of the Chronic Care Model (CCM).

Methods: Multi-centered randomized controlled clinical trial. The multifaceted intervention consisted in reorganization of care (delivery by trained chronic care coaches, using reminder systems, performing structured follow-up, empowering patients in self-monitoring and giving decision-support). In the control usual care was continued. Main outcome measures were changes in ETDRS visual acuity, optical coherence tomography (OCT) macular retinal thickness and quality of life (NEI VFQ-25 questionnaire).

Results: 169 consecutive patients in Swiss ophthalmology centers were included. Mean ETDRS baseline visual acuity of eyes with W-AMD was 57.8 (± 18.7). After 12 months, the between-group difference in mean change of ETDRS visual acuity was -4.8 (95%CI: -10.8 to +1.2, p = 0.15); difference in mean change of OCT was +14.0 (95% CI -39.6 to 67.6, p = 0.60); difference in mean change of NEI VFQ-25 composite score mean change was +2.1(95%CI: -1.3 to +5.5, p = 0.19).

Conclusions: The intervention aiming at improving chronic care was not associated with favorable outcomes within 12 months. Other approaches need to be tested to close the evidence-performance gap in W-AMD.

Trial registration: Controlled-Trials.com ISRCTN32507927.

Fig 1. Flow Chart of the study.

Fig 1 shows the flow chart of the study. The number of patients as well as the number of eyes with W-AMD is shown through the process.

Fig 2. ETDRS visual acuity.

Fig 2 shows outcome data for the ETDRS visual acuity through the study period. Point estimates are mean numbers of correctly identified letters, error bars represent 95% confidence intervals. The red line is for the intervention group, the black line is for the control group.

Fig 3. Optical coherence tomography retinal thickness.

Fig 3 shows the optical coherence tomography (OCT) macular retinal thickness in micrometers. Point estimates are mean values, error bars represent 95% confidence intervals. The red line is for the intervention group, the black line is for the control group.

Fig 4. NEI VFQ-25 quality of life.

Fig 4 shows the visual function specific quality of life measured by the NEIVFQ-25 composite score. Point estimates are mean values, error bars represent 95% confidence intervals. The red line is for the intervention group, the black line is for the control group.

Fig 5. Clinic visits at the ophthalmologists.

Fig 5 are boxplots comparing the intervention versus the control groups with regard to the number of visits at the ophthalmologist because of W-AMD. The hinges are the first and third quartile, the horizontal line is the median, the whiskers extend from the hinges to the value within 1.5 times the IQR.