NCT05543889

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 7, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2024

Completed
Last Updated

February 23, 2024

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

September 13, 2022

Last Update Submit

February 22, 2024

Conditions

Keywords

Limbal anterior chamber depthOptometristAngle-closureVan Herick

Outcome Measures

Primary Outcomes (1)

  • Agreement of community optometrists on measuring Limbal anterior chamber depth

    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 Outcomes (2)

  • Qualitative outcome measures from optometrists

    12 months

  • Qualitative outcome measures from patients

    12 months

Study Arms (2)

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

Other: Educational package

Interventions

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.

Optometrists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • New patients attending the glaucoma clinic at Moorfields Eye Hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Anish Jindal

    Moorfields Eye Hospital NHS Foundation Trust/UCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

December 7, 2022

Primary Completion

March 7, 2024

Study Completion

March 7, 2024

Last Updated

February 23, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations