- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05543889
Evaluation of Clinical Decisions and Assessment of Those at Risk of Primary Angle Closure by Community Optometrists
Increases in the aging population has resulted in increased demand for glaucoma services. Glaucoma is a disease that if untreated, can lead to blindness. This increase and need for long term treatment with monitoring have resulted in a significant demand in the hospital eye service (HES). Many departments are now facing a considerable backlog of outpatient appointments and it's essential that these appointments are reserved for patients who are at risk of glaucoma blindness.
Primary angle closure (PAC) glaucoma is a type of glaucoma, where the drainage route for the fluid inside the eye (known as the angle) is narrowed or blocked. It has been recently identified that approximately half of patients referred into the HES for a suspect narrow angle for further investigation are healthy and are immediately discharged. The exact reasons for these findings are unknown.
This project will investigate clinical decisions by community optometrists who account for the majority of PAC referrals into the HES, as well as assessing their ability to evaluate those at risk of PAC. This project will also examine whether clinical agreement could be improved by providing an educational package.
A clinical image database of angles will be acquired from glaucoma patients attending Moorfields Eye Hospital. A learning package discussing angle closure referral will also be developed. Community optometrists will be invited to complete a questionnaire on their clinical decision making. This will be followed by the vignette assessment, learning package and re-assessment.
If this educational package and/or any other identifiers are found to improve agreement levels, this could reduce the number of referrals and enable community monitoring of those at low risk of developing PAC glaucoma in their lifetime.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, EC1V 2PD
- Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
New patients attending the glaucoma clinic at Moorfields Eye Hospital
Exclusion Criteria:
- They cannot be examined using a table mounted slit lamp due to physical limitations or have gross nystagmus.
- Unable to consent
- If they are unable to communicate in English and there is no available interpreter that meets requirements set out by Moorfields standard operating policies for patients
- Under 18 years old
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients
100 patient participants will be recruited for limbal anterior chamber depth image capture.
These images will be used to develop the clinical vignette database
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Optometrists
50 optometrists will be recruited to undertake the clinical vignette assessment
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Online learning package that will discuss the van Herick technique, grading, accuracy and information and discusses the current guidelines for primary angle closure suspect referral.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement of community optometrists on measuring Limbal anterior chamber depth
Time Frame: 12 months
|
Levels of agreement and precision of optometrist observers before and after intervention of online educational package in assessment of Limbal anterior chamber depth as a surrogate measure of angle width.
Agreement will be measured via an online assessment vignette assessment package.
Weighted Kappa statistic and levels agreement will be the outcome measures
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative outcome measures from optometrists
Time Frame: 12 months
|
Questionnaire based outcomes capturing data around current practice, qualifications and training, knowledge and resources available in practice with regards to angle closure diagnosis and referral
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12 months
|
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Qualitative outcome measures from patients
Time Frame: 12 months
|
Difficulty in performing tests and satisfaction from the appointment (Likert scale 1-10), time taken (minutes) and costs of travel (£) to test site and waiting time to be examined from referral (months).
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12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Anish Jindal, Moorfields Eye Hospital NHS Foundation Trust/UCL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JINA1001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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