Choroidal Nevus Clinical Trial
Official title:
Validation of a Virtual Clinic for Choroidal Nevomelanocytic Lesions: Safety, Patient Acceptability and Health Economics Analysis
| Verified date | December 2018 |
| Source | Manchester University NHS Foundation Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 199 |
| Est. completion date | March 31, 2018 |
| Est. primary completion date | March 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | All patients attending the CNL clinics of MREH/MEH who have offered informed consent will be included in the study. 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Manchester University NHS Foundation Trust | National Institute for Health Research, United Kingdom |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Degree of agreement (kappa co-efficient) between management decisions reached clinically as opposed to those reached on the basis of imaging tests alone (virtual model) | Validation of the virtual model of service delivery will be sought by calculating the degree of agreement (kappa co-efficient) between management decisions (Discharge, Review or Refer patients) reached by direct clinical examination as opposed to decisions reached through assessing imaging tests only. | 18 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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