Validation of a Virtual Model of Service Delivery for Choroidal Nevi

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-08

Study Completion Date

2018-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Choroidal nevomelanocytic lesions have a high prevalence affecting up to 7% of the entire population and are increasingly incidentally identified during routine eye check- ups in community optometry services. Given the tendency to err on the side of caution, there is evidence of excessive referrals challenging service delivery in both tertiary eye units and specialist ocular oncology services. Although previous studies have examined the natural history and risk factors for growth of choroidal nevomelanocytic lesions, optimal delivery of management remains uncertain. Management approaches display diversity with respect to the number and type of baseline investigations, the duration and frequency of monitoring of relevant patients. Utilisation of the skills of allied health professionals in appropriate cases would allow streamlining service delivery in a socialised healthcare system, maximise capacity, and allow community services to play an enhanced role. However, the evidence for this model of delivery is lacking. Within existing models of care for these lesions, patients are faced with delays, need for more than one attendances to the hospital and increased anxiety around prognosis.

This project aims to answer the question of whether these low-risk, bland incidental findings might possibly be managed by allied health professionals with the use of clinical imaging and specific algorithms to make appropriate management decisions. We aim to validate a model of service delivery on a virtual basis that will accommodate for capacity pressures to accept all relevant referrals, while offering a safe service and optimising patient experience of care. We will thus validate the setting up of a virtual choroidal nevomelanocytic clinic in terms of safety and patient acceptability. More specifically, the degree of agreement between management decisions made by non-medical graders on the basis of imaging data alone as opposed to gold standard decisions (clinical and imaging tests combined) is examined. Health economics analysis of the proposed service delivery model will be undertaken to demonstrate cost-effectiveness.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Choroidal Nevus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

All patients attending the CNL clinics of MREH/MEH who have offered informed consent will be included in the study.

Exclusion Criteria

Patients who are then diagnosed with alternate pathologies other than CNL (erroneous referrals) will be excluded from agreement analysis. Recognition of alternate pathologies by non-medical graders will, however, be an additional outcome measure for this project. Cases of Congenital Hypertrophy of the Retinal Pigment Epithelium (CHRPE) will be classified as 'alternate pathology' for the purposes of this study. Exclusion criteria will be media opacities (cornea, lens, vitreous body) precluding adequate visualisation of fundus and incomplete set of imaging data.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Nevus Protocol v1.0

Identifier Type: -

Identifier Source: org_study_id