An interventional study of Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity in Proliferative Diabetic Retinopathy (PDR), sponsored by Swansea Bay University Health Board. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Swansea Bay University Health Board · Not applicable, Interventional, and Other
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity.
To assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists in performing laser treatment in line with the established protocols.
778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 481 interventional studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →Swansea Bay University Health Board is the lead sponsor of 9 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Other: Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity
Other: Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity
Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity
To assess the feasibility of a full clinical trial comparing trained Eye Care Professionals with ophthalmologists in performing laser treatment in line with the established protocols
Feasibility will be assessed using pre-specified progression criteria relating to: ECP participation and training completion, participant recruitment, follow-up completion, intervention compliance and retention of clinical equipoise. We will use Red, Amber, Green criteria to determine whether a larger scale trial can be done
Time frame: from enrollment to the 6 month follow up visit
estimate participant recruitment and retention rates.
to provide an estimate of the consent rates and retention rates by counting the number of patients screened and approached and how many consented. Of those, we will determine how many remained for the full 6 months and if patients withdrew or were lost to follow up we will determine when this occured and, where possible, why
Time frame: from baseline to 6 month visit
assess completeness and quality of outcome data collection.
to assess how well data is collected and how accurate it is by conducting a data cleasning exercise in the database to identify which data are missing and any outliers suggesting data is inaccurate
Time frame: from baseline to 6 month visit
evaluate the feasibility of intervention delivery by trained ECPs
to evalaute whether it is feasible for trained ECPs to deliver the treatment and whether patients accept them. this will include assessing (usign RAG criteria) whether ECPs agree to take part
Time frame: from baseline to 6 month visit
assess the acceptability of the intervention and trial processes to participants and stakeholders.
to assess whether patients consent and remain in the trial and whether stakeholders can adhere to the protocol
Time frame: from baseline to 6 month visit
describe clinical outcome distributions to inform the design of a future definitive trial
we will determine how will various clinical data items are collected in terms of availability and accuracy to determine whether they are suitable for a larger scale study which may use one as the basis for a sample size calculation. Data include number of laser sessions, visual acuity, central retinal thickness, sight loss/retention and various patient questionnaires
Time frame: from baseline to 6 month visit
assess the feasibility of collecting patient-reported outcome and resource-use measures
to determine whether participants complete the questionnaires provided and which questions are missed out / incorrecty completed. We will run missing data reports on the questionnaires to track patterns relating to problematic questions and identify outliers which may be incorrect data
Time frame: from baseline to 6 month visit
explore the resource use and cost drivers associated with ECP-delivered and ophthalmologist-delivered care pathways.
to collect data related to recourse use and other cost drivers associated with the novel treatment pathway using ECPs to determine whether there are cost savings to be made in using ECPs to deliver laser treatment
Time frame: from baseline to 6 month visit
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
Of 111 non-industry interventional studies with no phase under Diabetic Retinopathy, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's planned 9 months is below that.
Counting every sponsor, half of 126 studies reached it within 29 months; a quarter within 11 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Swansea Bay University Health Board