Angle Closure GlaucomaNCT05543889
Evaluation of Clinical Decisions and Assessment of Those at Risk of Primary Angle Closure by Community Optometrists
An observational study of Angle Closure Glaucoma, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Angle Closure Glaucoma
- What is being tested?
- Educational package
- How many people
- 163 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Dec 2022to 7 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- New patients attending the glaucoma clinic at Moorfields Eye Hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
London, EC1V 2PD
About this study
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.
Read more
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.
- Conditions
- Angle Closure Glaucoma
- Being tested
- Educational package
- Keywords
- Limbal anterior chamber depth, Optometrist, Angle-closure, Van Herick
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational packageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Educational package |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
Qualitative outcome measures from optometrists
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
Measured: 12 months
Qualitative outcome measures from patients
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start7 Dec 2022
- Primary completion7 Mar 2024 (estimated)
- Study completion7 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angle Closure GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anish Jindal, Principal investigator, Moorfields Eye Hospital NHS Foundation Trust/UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543889
- Sponsor's protocol ID
- JINA1001
- Status last verified
- Dec 2023
- First submitted
- 13 Sep 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Decisions and Assessment of Those at Risk of Primary Angle Closure by Community Optometrists
- ClinicalTrials.gov ID
- NCT05543889
- Acronym / sponsor ID
- JINA1001
- Conditions
- Angle Closure Glaucoma
- Keywords
- Limbal anterior chamber depth, Optometrist, Angle-closure, Van Herick
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 7 Mar 2024 (estimated)
- Study completion
- 7 Mar 2024 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Educational package50 optometrists will be recruited to undertake the clinical vignette assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- New patients attending the glaucoma clinic at Moorfields Eye Hospital
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational packageOnline learning package that will discuss the van Herick technique, grading, accuracy and information and discusses the current guidelines for primary angle closure suspect referral. | Other | Optometrists |
Primary outcome
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
2 secondary outcomes
Qualitative outcome measures from optometrists
Time frame: 12 months
Qualitative outcome measures from patients
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anish Jindal principal investigator
Moorfields Eye Hospital NHS Foundation Trust/UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angle Closure Glaucoma, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of community optometrists on measuring Limbal anterior chamber depth (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.