Evaluation of Clinical Decisions and Assessment of Those at Risk of Primary Angle Closure by Community Optometrists

February 22, 2024 updated by: Moorfields Eye Hospital NHS Foundation Trust

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

Active, not recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

New patients to the glaucoma service will be selected as they would be a real-world reflection of those who have been identified at risk of developing glaucoma that have been referred for glaucoma investigation within the hospital eye service from primary care. Furthermore, they would have an enriched sample of narrow angles that are required to achieve the desired the case-mix required for the image database within the set timelines.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Optometrists
50 optometrists will be recruited to undertake the clinical vignette assessment
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.

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
12 months
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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anish Jindal, Moorfields Eye Hospital NHS Foundation Trust/UCL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2022

Primary Completion (Estimated)

March 7, 2024

Study Completion (Estimated)

March 7, 2024

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Angle Closure Glaucoma

Clinical Trials on Educational package

Subscribe