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. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
NCT07923292, Not applicable, Recruiting, Swansea Bay University Health Board
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | 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. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists | ClinicalTrials.gov |
| NCT number | NCT07923292 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Swansea Bay University Health Board | ClinicalTrials.gov |
| Conditions | Proliferative Diabetic Retinopathy (PDR) | ClinicalTrials.gov |
| Interventions | Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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 | from enrollment to the 6 month follow up visit | 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 | ClinicalTrials.gov |
| Secondary | estimate participant recruitment and retention rates. | from baseline to 6 month visit | 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 | ClinicalTrials.gov |
| Secondary | assess completeness and quality of outcome data collection. | from baseline to 6 month visit | 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 | ClinicalTrials.gov |
| Secondary | evaluate the feasibility of intervention delivery by trained ECPs | from baseline to 6 month visit | 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 | ClinicalTrials.gov |
| Secondary | assess the acceptability of the intervention and trial processes to participants and stakeholders. | from baseline to 6 month visit | to assess whether patients consent and remain in the trial and whether stakeholders can adhere to the protocol | ClinicalTrials.gov |
| Secondary | describe clinical outcome distributions to inform the design of a future definitive trial | from baseline to 6 month visit | 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 | ClinicalTrials.gov |
| Secondary | assess the feasibility of collecting patient-reported outcome and resource-use measures | from baseline to 6 month visit | 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 | ClinicalTrials.gov |
| Secondary | explore the resource use and cost drivers associated with ECP-delivered and ophthalmologist-delivered care pathways. | from baseline to 6 month visit | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)