None listed
Conditions
Brief summary
This study is attempting to address shortcomings with the current DR screening process by implementing novel portable devices at point of care for high-risk patients. Non mydriatic camera (NMC) fundus photography has been approved by the NHMRC as a screening tool for DR. Combined pupillometry/electroretinography (ERG) has been proven sensitive and specific for DR screening. We will build on these promising novel screening tools through implementation in new clinical settings: point of care in hospital. Opportunistic diabetes case-finding by HbA1c screening of patients presenting to Blacktown ED identified 66% of patients had diabetes or pre-diabetes. Synchronising our DR screening protocol with established successful systems for identification of high-risk patients, using the WSLHD Diabetes Detection and Management Strategy & Western Sydney Diabetes Initiative will amplify the clinical impact of these initiatives by reducing the burden of blindness. The goals of this study align with the WSLHD Better West Strategic Priorities which identified the priority for “Healthy people- Overcome diabetes through screening and early management”. Our aim is to investigate whether NMC and ERG screening at the point of care in patients with high risk for DR, results in improved detection of new and vision threatening DR compared to current screening practices. This study aims to establish: *The proportion of patients with undiagnosed and/or vision threatening DR in patients presenting to hospital emergency departments with raised blood sugar level (BSL) and/or HbA1c, or high-risk foot clinics. The rate of undiagnosed DR will be compared to population based estimates from the 2016 National Eye Health Survey and ophthalmology clinic populations. *The various methods (NMC, ERG, MC and computer-automated DR screening) will be compared with respect to: *Rate of successful administration eg. proportion of retinal images that are readable. *The relative diagnostic accuracy in this novel setting *Cost of the procedure from health care provider perspective (time, personnel, equipment). *The value of ERG in addition to NMC in screening this population. *The validity of portable NMC and ERG compared with dilated 2-field MC. *Fundus DR grading by an automated image screening program will be compared to human graders with a cost-benefit analysis. *The value of this screening protocol compared with community screening. In combination, these aims will provide an evidence base for clinically appropriate HbA1c and BSL screening criteria.
Interventions
All participants received three interventions in a fixed order at one clinic visit:
(1) Two-field bilateral Non-mydriatic fundus photography (NMFP);
(2) Combined electroretinography & pupillometry (ERG);
(3) Two-field bilateral mydriadic fundus photography (MFP) - the control intervention.
There was no pre-specified washout time between interventions.
Intervention Name: (1) Two-field bilateral Non-mydriatic fundus photography (NMFP)
*RetinaVUE 100 registered trade mark (Welch Allyn, Macquarie P
All participants received three interventions in a fixed order at one clinic visit: (1) Two-field bilateral Non-mydriatic fundus photography (NMFP); (2) Combined electroretinography & pupillometry (ERG); (3) Two-field bilateral mydriadic fundus photography (MFP) - the control intervention. There was no pre-specified washout time between interventions. Intervention Name: (1) Two-field bilateral Non-mydriatic fundus photography (NMFP) *RetinaVUE 100 registered trade mark (Welch Allyn, Macquarie Park, Australia): portable camera provided to enrolled patients in the clinic *performed a research assistant with prior computer-based and face-to-face NMFP training *administered once clinic admission, taking approximately 2-10 minutes for complete examination of both eyes *digital fundus images are then interpreted by an ophthalmologist Intervention Name: (2) combined electroretinography & pupillometry (ERG) *RETeval registered trade mark (Welch Allyn, Macquarie Park, Australia): full-field electroreintography and pupillometry device *performed by a research assistant with prior training *administered once clinic admission, taking approximately 2-10 minutes for complete examination of both eyes *the automatically generated report is then interpreted by an ophthalmologist
Sponsors
Westmead Hospital, Dept of Ophthalmology
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participation was offered to diabetic patients over 18 years of age, who attended the Foot Ulcer or Integrated Diabetes Clinics at these hospitals by the treating endocrinologist.
Exclusion criteria
* Patients with photosensitive epilepsy were excluded from participation, * Patients with a family history of angle-closure glaucoma were not offered pupil dilation
Outcome results
None listed