Topic: Diabetes
Conditions
Interventions
Patients will be randomised to two arms: either personalised risk-based screening intervals or annual screening (usual care) intervals. The grading result will be sent to the ISDR data warehouse as th
Sponsors
Royal Liverpool and Broadgreen University Hospital NHS Trust
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who: 1. Are aged 12 years and over 2. Attend for retinal screening in a community clinic or a screening assessment clinic during the recruitment period 3. Are registered with a participating GP practice 4. Are included in the study data warehouse (have not opted out) 5. Have no retinopathy or have retinopathy and maculopathy less than the definition of screen positive DR 6. Have gradeable digital retinal images 7. Give their informed consent for participation 8. Are not involved in any trial investigating a treatment aiming at preventing or modifying the development of STDR
Exclusion criteria
Exclusion criteria: Patients who: 1. Are under 12 years 2. Are not registered with a participating GP practice 3. Have opted out from the study data warehouse 4. Have screen positive DR 5. Have significant other eye disease requiring referral to the HES 6. Are ineligible for screening for whatever reason, including having ungradeable digital retinal images 7. Do not give consent for participation in the RCT 8. Are involved in any trial investigating a treatment aiming at preventing or modifying the development of STDR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of attendance rates for follow-up screening in the two arms of the study. [Non-attendance is defined as failure to attend two appointments for screening (usually within 6 weeks of each other)]. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of cases of STDR detected 2. Retinopathy level at screening (Liverpool and NDESP grading) 3. Maculopathy level at screening (Liverpool and NDESP grading) 4. Number of false positive screening episodes 5. Number of screening appointments 6. Number of dedicated diabetes assessment clinic appointments 7. Number of other eye appointments for diabetic eye disease 8. Visual acuity (logMAR) 9. New visual impairment (= +0.50 logMAR) 10. New visual impairment due to diabetic retinopathy (= +0.50 logMAR) 11. Number of missed appointments to screening 12. Patient acceptability measures (using a questionnaire designed for the trial) 13. Quality-adjusted life years (QALYs) estimated using EQ-5D-5L and Health Utilities Index Mark 3 (HUI3) 14. Cost per QALY gained | — |
Countries
United Kingdom
Outcome results
None listed