Age Related Macular DegenerationOPTIMISENCT04920071
Optimising Visual Acuity Measurement in Macular Degeneration
An observational study of Age Related Macular Degeneration, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Age-related macular degeneration (AMD) is the leading cause of visual impairment in the UK. The condition is characterised by damage to the region of the retina (macula) responsible for detailed central vision, this leading to problems with tasks such as reading and face-recognition. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Visual acuity and contrast sensitivity measurement
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jul 2019to 31 May 2023
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with reduced vision attributable to AMD will be recruited and tested as part of this study.
Who may be able to join
- Absence of ocular disease in either eye
- Male or female, aged 18 years or older
- The absence of significant media opacities
- Ability to understand nature/purpose of the study and to provide informed consent
- Ability to follow instructions and complete the study
- Ability to speak English
Who cannot join
- Any systemic disease likely to affect visual performance
- Presence of any ocular disease
- Hearing impairment sufficient to interfere with hearing instructions
- Poor understanding of English language and/or alphabet
- Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust
London
About this study
Official title: Quantifying the Disease Signal to Measurement Noise Ratio With the Moorfields Acuity Chart in Age-related Macular Disease
Age-related macular degeneration (AMD) is the leading cause of visual impairment in the UK. The condition is characterised by damage to the region of the retina (macula) responsible for detailed central vision, this leading to problems with tasks such as reading and face-recognition. The ability to accurately measure vision is central to the detection and management of AMD. The most common test (visual acuity) typically requires patients to identify black letters of varying size on a white background, with the smallest letter read representing the limit of vision. Conventional tests are however known to be variable, making it difficult to determine if a true change in vision has occurred.
Previous work has found the Moorfields Acuity Chart, which contains specially constructed letters composed of a black core and white border, to be more sensitive to early AMD compared to standard charts. Despite this advantage, it is unclear if there is an associated increase in measurement variability with the Moorfields Acuity Chart and if this changes with the severity of disease. In this study, the relationship between vision test sensitivity and measurement variability will be quantified with both conventional visual acuity tests and the new Moorfields Acuity Chart to identify the optimal vision test to detect and monitor AMD in the clinic.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Visual acuity and contrast sensitivity measurement
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual acuity and contrast sensitivity measurementDevice
Those subjects who meet the inclusion criteria will undergo the study tests. These measurements will be performed on one eye only. Visual acuity will be quantified using two forms of the MAC chart (MAC 1 and 2) and two forms of a conventional letter design chart (C1 and 2). Contrast sensitivity will be measured using the two forms of the Pelli-Robson chart (CS1 and CS2). The order with which the test charts will be presented, in addition to the charts used (i.e. MAC 1 or 2, C1 or 2, and CS1 or 2), will be selected at random. Finally, a measurement of eye length will be collected using an IOL Master (Carl-Zeiss Meditec, USA).
| Study group | Role | What they receive |
|---|---|---|
| Control | 150 healthy control participants Receives: Device: Visual acuity and contrast sensitivity measurement | |
| AMD Cohort high-contrast VA group i | Better than 0.4 logMAR Receives: Device: Visual acuity and contrast sensitivity measurement | |
| AMD Cohort high-contrast VA group ii | 0.4-0.6 logMAR Receives: Device: Visual acuity and contrast sensitivity measurement | |
| AMD Cohort high-contrast VA group iii | 0.6-0.8 logMAR Receives: Device: Visual acuity and contrast sensitivity measurement | |
| AMD Cohort high-contrast VA group iv | 0.8-1.0 logMAR Receives: Device: Visual acuity and contrast sensitivity measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of disease signal (test sensitivity) to measurement noise (variability) in AMD with conventional and Moorfields Acuity Charts
The disease signal to measurement noise ratio (SNR) is defined as the ratio of AMD test sensitivity to the degree of measurement variability for each chart investigated in this study.
Measured: 2 years
Secondary outcomes (1)
Test-retest variability for the Moorfields Acuity Chart and conventional logMAR visual acuity tests
Measurement variability (difference in two measures captured using the same vision test on the same day) will be quantified for each vision test used in this study. This analysis will also be undertaken for participants with a range of AMD related vision loss.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start25 Jul 2019
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920071
- Sponsor's protocol ID
- MULP1001
- Acronym
- OPTIMISE
- Status last verified
- Mar 2024
- First submitted
- 9 Feb 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying the Disease Signal to Measurement Noise Ratio With the Moorfields Acuity Chart in Age-related Macular Disease
- ClinicalTrials.gov ID
- NCT04920071
- Acronym / sponsor ID
- OPTIMISE / MULP1001
- Conditions
- Age Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 9 Jun 2021 (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.
Age-related macular degeneration (AMD) is the leading cause of visual impairment in the UK. The condition is characterised by damage to the region of the retina (macula) responsible for detailed central vision, this leading to problems with tasks such as reading and face-recognition. The ability to accurately measure vision is central to the detection and management of AMD. The most common test (visual acuity) typically requires patients to identify black letters of varying size on a white background, with the smallest letter read representing the limit of vision. Conventional tests are however known to be variable, making it difficult to determine if a true change in vision has occurred.
Previous work has found the Moorfields Acuity Chart, which contains specially constructed letters composed of a black core and white border, to be more sensitive to early AMD compared to standard charts. Despite this advantage, it is unclear if there is an associated increase in measurement variability with the Moorfields Acuity Chart and if this changes with the severity of disease. In this study, the relationship between vision test sensitivity and measurement variability will be quantified with both conventional visual acuity tests and the new Moorfields Acuity Chart to identify the optimal vision test to detect and monitor AMD in the clinic.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | – | Device: Visual acuity and contrast sensitivity measurement150 healthy control participants |
| AMD Cohort high-contrast VA group i | – | Device: Visual acuity and contrast sensitivity measurementBetter than 0.4 logMAR |
| AMD Cohort high-contrast VA group ii | – | Device: Visual acuity and contrast sensitivity measurement0.4-0.6 logMAR |
| AMD Cohort high-contrast VA group iii | – | Device: Visual acuity and contrast sensitivity measurement0.6-0.8 logMAR |
| AMD Cohort high-contrast VA group iv | – | Device: Visual acuity and contrast sensitivity measurement0.8-1.0 logMAR |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with reduced vision attributable to AMD will be recruited and tested as part of this study.
Key inclusion criteria (6 listed)
- Absence of ocular disease in either eye
- Male or female, aged 18 years or older
- The absence of significant media opacities
- Ability to understand nature/purpose of the study and to provide informed consent
- Ability to follow instructions and complete the study
Key exclusion criteria (5 listed)
- Any systemic disease likely to affect visual performance
- Presence of any ocular disease
- Hearing impairment sufficient to interfere with hearing instructions
- Poor understanding of English language and/or alphabet
- Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.
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 |
|---|---|---|
| Visual acuity and contrast sensitivity measurementThose subjects who meet the inclusion criteria will undergo the study tests. These measurements will be performed on one eye only. Visual acuity will be quantified using two forms of the MAC chart (MAC 1 and 2) and two forms of a conventional letter design chart (C1 and 2). Contrast sensitivity will be measured using the two forms of the Pelli-Robson chart (CS1 and CS2). The order with which the test charts will be presented, in addition to the charts used (i.e. MAC 1 or 2, C1 or 2, and CS1 or 2), will be selected at random. Finally, a measurement of eye length will be collected using an IOL Master (Carl-Zeiss Meditec, USA). | Device | AMD Cohort high-contrast VA group i, AMD Cohort high-contrast VA group ii, AMD Cohort high-contrast VA group iii, AMD Cohort high-contrast VA group iv, Control |
Primary outcome
Ratio of disease signal (test sensitivity) to measurement noise (variability) in AMD with conventional and Moorfields Acuity Charts
Time frame: 2 years
The disease signal to measurement noise ratio (SNR) is defined as the ratio of AMD test sensitivity to the degree of measurement variability for each chart investigated in this study.
1 secondary outcome
Test-retest variability for the Moorfields Acuity Chart and conventional logMAR visual acuity tests
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Age Related Macular Degeneration, 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 13 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ratio of disease signal (test sensitivity) to measurement noise (variability) in AMD with conventional and Moorfields Acuity Charts (time frame: 2 years). 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 13 Mar 2024.