Keratoconic SubjectsMACKNCT02429609
Exploring the Psychophysics of Keratoconus Using the Moorfields Acuity Chart
A study testing Moorfields Acuity Chart in people with Keratoconic Subjects, run by Moorfields Eye Hospital NHS Foundation Trust.
Trial summary
The measurement of visual acuity is made using black letters of varying size superimposed on a uniform white background. The objective is to determine the smallest letter, or optotype, that can be correctly identified. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconic Subjects
- What is being tested?
- Moorfields Acuity Chart
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2015to 30 Apr 2016
- Phase
- Interventional
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Keratoconic subjects (50):
- Age 18-40 years.
- The presence of keratoconus in at least one eye.
- The absence of significant media opacities (e.g. cataract, corneal scarring).
- The absence of any other ocular pathology (e.g. glaucoma, diabetic retinopathy, uveitis).
- The absence of amblyopia in the test eye.
- No previous ocular surgery (e.g. corneal crosslinking, cataract surgery, etc.)
- Best corrected visual acuity better than or equal to 6/60 (1.0 logMAR).
- Pupil diameter ≥3 mm and ≤7 mm in normal room illumination.
Healthy subjects (30):
- Age 18-35 years.
- The absence of clinically significant keratoconus.
- The absence of significant media opacities. (e.g. cataract, corneal scarring).
- The absence of any other ocular pathology (e.g. glaucoma, diabetic retinopathy, uveitis).
- The absence of amblyopia in the test eye.
- No previous ocular surgery (e.g. corneal crosslinking, cataract surgery, etc.)
- Best corrected visual acuity better than or equal to 6/9 (0.1 logMAR).
- Pupil diameter ≥3 mm and ≤7 mm in normal room illumination.
About this study
The measurement of visual acuity is made using black letters of varying size superimposed on a uniform white background. The objective is to determine the smallest letter, or optotype, that can be correctly identified. One limitation of current tests is the variability of measurements, this making it difficult for clinicians to determine if changes in visual acuity are related to ocular disease. This variability has been attributed to the design of current optotypes, in particular their differing legibilities. Our group has recently demonstrated that a new type of letter chart (Moorfields Acuity Chart), containing letters with a black core and a white border presented on a grey background, reduces the variability of visual acuity measurements. In this study the investigators wish to determine if changes in vision owing to keratoconus, a disease that causes the cornea to adopt an irregular shape, may be detected more easily using the Moorfields Acuity Chart compared with conventional letter charts.
- Conditions
- Keratoconic Subjects
- Being tested
- Moorfields Acuity Chart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moorfields Acuity ChartDevice
| Study group | Role | What they receive |
|---|---|---|
| Keratoconic subjects | Experimental | 1. Short clinical interview (Questions pertaining to ocular and systemic health, medications, family history and date of birth). (approx. 2 minutes)
2. Visual acuity measurement using EDTRS chart at 4 m (approx. 4 minutes)
3. Refraction: retinoscopy and subjective, at 4m (approx. 10 minutes)
4. Anterior eye examination (approx. 4 minutes)
5. Fundus examination using binocular indirect ophthalmoscopy or a standard ophthalmoscope - to screen for eye disease that is likely to affect visual ability in this study. (approx. 5 minutes)
6. Corneal topography measurement with an Oculus Pentacam (Oculus Gmbh., Germany). (approx. 5 minutes)
Two measurements of visual acuity will be made:
1. Standard ETDRS logMAR acuity measurement (5 minutes)
2. Vanishing Optotype logMAR acuity measurement (5 minutes) Receives: Device: Moorfields Acuity Chart |
| Healthy subjects | Experimental | 1. Short clinical interview (Questions pertaining to ocular and systemic health, medications, family history and date of birth). (approx. 2 minutes)
2. Visual acuity measurement using EDTRS chart at 4 m (approx. 4 minutes)
3. Refraction: retinoscopy and subjective, at 4m (approx. 10 minutes)
4. Anterior eye examination (approx. 4 minutes)
5. Fundus examination using binocular indirect ophthalmoscopy or a standard ophthalmoscope - to screen for eye disease that is likely to affect visual ability in this study. (approx. 5 minutes)
6. Corneal topography measurement with an Oculus Pentacam (Oculus Gmbh., Germany). (approx. 5 minutes)
Two measurements of visual acuity will be made:
1. Standard ETDRS logMAR acuity measurement (5 minutes)
2. Vanishing Optotype logMAR acuity measurement (5 minutes) Receives: Device: Moorfields Acuity Chart |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative difference in visual acuity measurement between subjects with and without keratoconus when examined with different types of visual acuity chart.
Measured: 9 months
Secondary outcomes (1)
The relationship (if any) between optical imperfections (high order aberrations) and measurements of visual acuity when measured using different test chart designs.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study start15 Apr 2015
- Primary completion30 Apr 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconic SubjectsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This in a basic science exploratory study to examine the effect of keratoconus on visual acuity as measured using pseudo-high-pass filtered optotypes. The MAC will be compared with the standard charts currently used to monitor visual acuity (logMAR chart) and contrast sensitivity (Pelli-Robson). "Researcher effects" and "researcher bias" will be controlled by setting a written protocol for all testing procedures. Each procedure will be standardised and random checks will be made by the chief investigator on all anonymous record sheets. Neither the chief investigator nor the co-researchers will act as participants for this study.
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT02429609
- Sponsor's protocol ID
- ANDO1009
- Acronym
- MACK
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2015
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Psychophysics of Keratoconus Using the Moorfields Acuity Chart
- ClinicalTrials.gov ID
- NCT02429609
- Acronym / sponsor ID
- MACK / ANDO1009
- Conditions
- Keratoconic Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 29 Apr 2015 (estimated)
- 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.
The measurement of visual acuity is made using black letters of varying size superimposed on a uniform white background. The objective is to determine the smallest letter, or optotype, that can be correctly identified. One limitation of current tests is the variability of measurements, this making it difficult for clinicians to determine if changes in visual acuity are related to ocular disease. This variability has been attributed to the design of current optotypes, in particular their differing legibilities. Our group has recently demonstrated that a new type of letter chart (Moorfields Acuity Chart), containing letters with a black core and a white border presented on a grey background, reduces the variability of visual acuity measurements. In this study the investigators wish to determine if changes in vision owing to keratoconus, a disease that causes the cornea to adopt an irregular shape, may be detected more easily using the Moorfields Acuity Chart compared with conventional letter charts.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This in a basic science exploratory study to examine the effect of keratoconus on visual acuity as measured using pseudo-high-pass filtered optotypes. The MAC will be compared with the standard charts currently used to monitor visual acuity (logMAR chart) and contrast sensitivity (Pelli-Robson). "Researcher effects" and "researcher bias" will be controlled by setting a written protocol for all testing procedures. Each procedure will be standardised and random checks will be made by the chief investigator on all anonymous record sheets. Neither the chief investigator nor the co-researchers will act as participants for this study.
| Arm | Type | Receives |
|---|---|---|
| Keratoconic subjects | Experimental | Device: Moorfields Acuity Chart1. Short clinical interview (Questions pertaining to ocular and systemic health, medications, family history and date of birth). (approx. 2 minutes) 2. Visual acuity measurement using EDTRS chart at 4 m (approx. 4 minutes) 3. Refraction: retinoscopy and subjective, at 4m (approx. 10 minutes) 4. Anterior eye examination (approx. 4 minutes) 5. Fundus examination using binocular indirect ophthalmoscopy or a standard ophthalmoscope - to screen for eye disease that is likely to affect visual ability in this study. (approx. 5 minutes) 6. Corneal topography measurement with an Oculus Pentacam (Oculus Gmbh., Germany). (approx. 5 minutes) Two measurements of visual acuity will be made: 1. Standard ETDRS logMAR acuity measurement (5 minutes) 2. Vanishing Optotype logMAR acuity measurement (5 minutes) |
| Healthy subjects | Experimental | Device: Moorfields Acuity Chart1. Short clinical interview (Questions pertaining to ocular and systemic health, medications, family history and date of birth). (approx. 2 minutes) 2. Visual acuity measurement using EDTRS chart at 4 m (approx. 4 minutes) 3. Refraction: retinoscopy and subjective, at 4m (approx. 10 minutes) 4. Anterior eye examination (approx. 4 minutes) 5. Fundus examination using binocular indirect ophthalmoscopy or a standard ophthalmoscope - to screen for eye disease that is likely to affect visual ability in this study. (approx. 5 minutes) 6. Corneal topography measurement with an Oculus Pentacam (Oculus Gmbh., Germany). (approx. 5 minutes) Two measurements of visual acuity will be made: 1. Standard ETDRS logMAR acuity measurement (5 minutes) 2. Vanishing Optotype logMAR acuity measurement (5 minutes) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Moorfields Acuity Chart | Device | Healthy subjects, Keratoconic subjects |
Primary outcome
The relative difference in visual acuity measurement between subjects with and without keratoconus when examined with different types of visual acuity chart.
Time frame: 9 months
1 secondary outcome
The relationship (if any) between optical imperfections (high order aberrations) and measurements of visual acuity when measured using different test chart designs.
Time frame: 9 months
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 12 Apr 2022.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Moorfields Acuity Chart in people with Keratoconic Subjects, run by Moorfields Eye Hospital NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The relative difference in visual acuity measurement between subjects with and without keratoconus when examined with different types of visual acuity chart. (time frame: 9 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 12 Apr 2022.