Corneal TopographyOCUTOPNCT07895849
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
A study testing OCUTOP hand-held corneal topographer with OCUGRAPH software and Reference instrument measurement (corneal topography and tear-film assessment) in people with Corneal Topography and Dry Eye Syndromes, run by University of Plymouth at 2 sites in United Kingdom.
Trial summary
The OCUTOP is a new hand-held camera that photographs the front of the eye to map the shape of the cornea and to assess the tear film. Before it can be used in eye care it must be compared with the instruments that clinics already use. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Topography, Dry Eye Syndromes, Keratoconus
- What is being tested?
- OCUTOP hand-held corneal topographer with OCUGRAPH software and Reference instrument measurement (corneal topography and tear-film assessment)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2027to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Aged 18 years or over.
- Able to give written informed consent.
- Attending the participating clinic for any reason.
- Able to sit and fixate on a target for the duration of the measurements.
Who cannot join
- Unable or unwilling to give informed consent.
- Active infection or inflammation of the eye or eyelids, or broken skin around the eye, at the study visit.
- Any condition that prevents the eye being kept open or the head being kept steady for the measurements (for example severe blepharospasm or nystagmus).
- Contact lens wear on the day of the visit.
- Eye surgery within the previous three months.
- Known sensitivity to the device's rim material or to the disinfectant wipe used between participants.
- Taking part in another clinical investigation that could interfere with this one.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites
Simon Berry Optometrist
Durham, County Durham, DH1 2HX
Simon Berry, +44 191 375 7544, simon@simonberry.co.uk
Simon Berry
Centre for Eyecare Excellence, University of Plymouth
Plymouth, Devon, PL4 8AA
Daniela Oehring, PhD, +44 7584 428035, daniela.oehring@plymouth.ac.uk
Daniela Oehring, PhD
About this study
Official title: Performance Evaluation of the OCUTOP Corneal Topographer With OCUGRAPH Software: Agreement With Reference Instruments, Repeatability and Safety in an Unselected Adult Clinic Population
The OCUTOP is a new hand-held camera that photographs the front of the eye to map the shape of the cornea and to assess the tear film. Before it can be used in eye care it must be compared with the instruments that clinics already use. In this study, adults attending one of two UK eye clinics for an ordinary appointment are invited to have both eyes measured once with the OCUTOP and with the clinic's usual instruments, in a random order, and to complete two short questionnaires. The visit adds about 30 minutes; nothing is put in the eye and no treatment is given. The study measures how closely the OCUTOP agrees with the reference instruments for corneal curvature, tear break-up time and tear meniscus height, how repeatable it is, how often it produces usable images, how acceptable participants and clinicians find it, and whether any adverse events occur.
Read the detailed description
Prospective, single-visit, within-participant method-comparison and repeatability study of the OCUTOP corneal topographer with OCUGRAPH software at two non-NHS sites in the United Kingdom (Centre for Eyecare Excellence, University of Plymouth; Simon Berry Optometrist, Durham). Participants are adults attending either clinic for any reason, invited consecutively; reporting groups (normal cornea, keratoconus, previous corneal or refractive surgery, corneal scar, high myopia, dry eye) are formed afterwards from the clinical record. Both eyes are measured with the OCUTOP and with the site reference instruments; the order of instrument blocks and of eyes is randomised. Reference instruments are the Pentacam HR and Keratograph 5M at Site 01 (with the Medmont E300 as an additional topographer) and the Myah at Site 02. The study is an estimation study without a formal hypothesis test: for each co-primary endpoint the mean paired difference (OCUTOP minus reference) and the 95% limits of agreement, each with 95% confidence intervals, are reported and read against pre-specified clinical interpretation thresholds. The sample size of 100 evaluable participants (one analysis eye each; recruitment ceiling 150) is set by the precision of the limits of agreement. Secondary analyses cover repeatability, agreement for K1, K2 and astigmatism vectors, classification agreement at TFOS cut-offs, inter-operator reproducibility, acquisition yield, participant acceptability and clinician usability, symptom scores and safety. A Statistical Analysis Plan is signed before the first participant. The investigation is conducted under the UK Medical Devices Regulations 2002 (regulation 16) and ISO 14155:2026, with MHRA notification and Research Ethics Committee review through IRAS (370513).
- Conditions
- Corneal Topography, Dry Eye Syndromes, Keratoconus, Healthy Volunteers
- Being tested
- OCUTOP hand-held corneal topographer with OCUGRAPH software, Reference instrument measurement (corneal topography and tear-film assessment)
- Keywords
- corneal topography, non-invasive tear break-up time, tear meniscus height, method comparison
- Medical subject headings
- Dry Eye Syndromes, Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCUTOP hand-held corneal topographer with OCUGRAPH softwareDevice
Investigational hand-held, non-contact, Placido-based corneal topographer with integrated non-invasive tear-film assessment (tear break-up time and tear meniscus height), operated through the OCUGRAPH software on a Windows computer. The device rim rests on the skin around the eye; nothing touches the eye. Both eyes are imaged at one visit, with repeat captures for repeatability. The device is not UKCA or CE marked and is labelled exclusively for clinical investigation. Manufacturer: OCUWELL Limited.
Reference instrument measurement (corneal topography and tear-film assessment)Diagnostic test
Corneal topography and non-invasive tear-film assessment with the CE or UKCA marked instruments in routine use at each site, used within their intended purpose: Pentacam HR (topography) and Keratograph 5M (tear film) at Site 01, with the Medmont E300 as an additional topographer; Myah (topography and tear film) at Site 02. Both eyes, same visit, repeat captures for repeatability.
| Study group | Role | What they receive |
|---|---|---|
| OCUTOP and reference instruments | Experimental | All participants. At a single visit, both eyes are measured with the OCUTOP corneal topographer (OCUGRAPH software) and with the site reference instruments (Pentacam HR, Keratograph 5M and Medmont E300 at Site 01; Myah at Site 02), in a randomised order of instrument blocks and eyes, with a rest of at least 5 minutes between blocks. Participants complete two short questionnaires. No treatment is given and there is no follow-up. Receives: Device: OCUTOP hand-held corneal topographer with OCUGRAPH software; Diagnostic Test: Reference instrument measurement (corneal topography and tear-film assessment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between the OCUTOP and the reference instrument for central simulated mean keratometry (K-mean)
Mean paired difference (OCUTOP minus reference, dioptres) with 95% confidence interval, and Bland-Altman 95% limits of agreement with their 95% confidence intervals, in the analysis eye, pooled across sites and by site. Reference: Pentacam HR (Site 01), Myah (Site 02).
Measured: Single study visit (Day 1)
Agreement between the OCUTOP and the reference instrument for first non-invasive tear break-up time (NIBUT-first)
Mean paired difference (OCUTOP minus reference, seconds) with 95% confidence interval, and Bland-Altman 95% limits of agreement with their 95% confidence intervals, in the analysis eye, pooled across sites and by site. Reference: Keratograph 5M (Site 01), Myah (Site 02).
Measured: Single study visit (Day 1)
Agreement between the OCUTOP and the reference instrument for average non-invasive tear break-up time (NIBUT-average)
Mean paired difference (OCUTOP minus reference, seconds) with 95% confidence interval, and Bland-Altman 95% limits of agreement with their 95% confidence intervals, in the analysis eye, pooled across sites and by site. Reference: Keratograph 5M (Site 01), Myah (Site 02).
Measured: Single study visit (Day 1)
Agreement between the OCUTOP and the reference instrument for central lower tear meniscus height (TMH)
Mean paired difference (OCUTOP minus reference, millimetres) with 95% confidence interval, and Bland-Altman 95% limits of agreement with their 95% confidence intervals, in the analysis eye, pooled across sites and by site. Reference: Keratograph 5M (Site 01), Myah (Site 02).
Measured: Single study visit (Day 1)
Secondary outcomes (9)
Repeatability of the OCUTOP and of each reference instrument
Within-subject standard deviation, repeatability coefficient, coefficient of variation and intraclass correlation coefficient from repeat captures, for K-mean, NIBUT-first, NIBUT-average, TMH, K1, K2 and the astigmatism vectors J0 and J45.
Measured: Single study visit (Day 1)
Agreement for K1, K2 and the astigmatism vectors J0 and J45
Mean paired difference and 95% limits of agreement with 95% confidence intervals for K1, K2, J0 and J45, OCUTOP against each reference instrument and, at Site 01, against the Medmont E300.
Measured: Single study visit (Day 1)
Classification agreement at TFOS cut-offs
Agreement between the OCUTOP and the reference instrument in classifying eyes at the TFOS cut-offs (NIBUT below 10 s; TMH below 0.2 mm): Cohen's kappa, sensitivity and specificity with the reference as standard.
Measured: Single study visit (Day 1)
Inter-operator reproducibility of the OCUTOP
Between-operator differences and limits of agreement for the primary measures in the first 20 participants per site, each measured with the OCUTOP by two operators.
Measured: Single study visit (Day 1)
Acquisition yield
Proportion of OCUTOP captures and videos rated unusable, overall and by site, reporting group and operator.
Measured: Single study visit (Day 1)
Participant acceptability and clinician usability
Participant acceptability of the OCUTOP measured with a short study questionnaire (comfort, duration, willingness to be measured again); clinician usability of the device and the OCUGRAPH interface measured with the System Usability Scale (0 to 100, higher is better).
Measured: Single study visit (Day 1)
Agreement and repeatability within record-defined groups
Descriptive agreement and repeatability statistics for the primary measures within the reporting groups formed from the clinical record (normal cornea, keratoconus, previous corneal or refractive surgery, corneal scar, high myopia, dry eye).
Measured: Single study visit (Day 1)
Dry-eye symptom scores and their relation to tear-film measures
DEQ-5 and SPEED questionnaire scores, their correlation with NIBUT and TMH from each instrument, and dry-eye classification by the TFOS DEWS III definition.
Measured: Single study visit (Day 1)
Safety: adverse events, adverse device effects, device deficiencies and participant-reported discomfort
Number and nature of adverse events, adverse device effects and device deficiencies recorded during and after the visit, and participant-reported discomfort on the acceptability questionnaire.
Measured: Single study visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal TopographyStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-participant method-comparison and repeatability study. Every participant has both eyes measured with the investigational device and with the site reference instruments at a single visit; only the order of the instrument blocks and of the eyes is randomised.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Collaborators
- OCUWELL Limited
- Responsible party
- Principal investigator, Dr Daniela Oehring, University of Plymouth
- Investigators
- Daniela Oehring, PhD, Principal investigator, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895849
- Sponsor's protocol ID
- OW-CIP-001
- Other IDs
- 370513
- Acronym
- OCUTOP
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participants are asked at consent whether anonymised data may support future research. Any sharing of de-identified individual participant data would be under a data sharing agreement with the University of Plymouth; the plan will be confirmed before study completion.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the OCUTOP Corneal Topographer With OCUGRAPH Software: Agreement With Reference Instruments, Repeatability and Safety in an Unselected Adult Clinic Population
- ClinicalTrials.gov ID
- NCT07895849
- Acronym / sponsor ID
- OCUTOP / OW-CIP-001
- Conditions
- Corneal Topography, Dry Eye Syndromes, Keratoconus, Healthy Volunteers
- Keywords
- corneal topography, non-invasive tear break-up time, tear meniscus height, method comparison
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Collaborators
- OCUWELL Limited
- Study start
- Jan 2027 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 26 Oct 2026 (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.
The OCUTOP is a new hand-held camera that photographs the front of the eye to map the shape of the cornea and to assess the tear film. Before it can be used in eye care it must be compared with the instruments that clinics already use. In this study, adults attending one of two UK eye clinics for an ordinary appointment are invited to have both eyes measured once with the OCUTOP and with the clinic's usual instruments, in a random order, and to complete two short questionnaires. The visit adds about 30 minutes; nothing is put in the eye and no treatment is given. The study measures how closely the OCUTOP agrees with the reference instruments for corneal curvature, tear break-up time and tear meniscus height, how repeatable it is, how often it produces usable images, how acceptable participants and clinicians find it, and whether any adverse events occur.
Detailed description
Prospective, single-visit, within-participant method-comparison and repeatability study of the OCUTOP corneal topographer with OCUGRAPH software at two non-NHS sites in the United Kingdom (Centre for Eyecare Excellence, University of Plymouth; Simon Berry Optometrist, Durham). Participants are adults attending either clinic for any reason, invited consecutively; reporting groups (normal cornea, keratoconus, previous corneal or refractive surgery, corneal scar, high myopia, dry eye) are formed afterwards from the clinical record. Both eyes are measured with the OCUTOP and with the site reference instruments; the order of instrument blocks and of eyes is randomised. Reference instruments are the Pentacam HR and Keratograph 5M at Site 01 (with the Medmont E300 as an additional topographer) and the Myah at Site 02. The study is an estimation study without a formal hypothesis test: for each co-primary endpoint the mean paired difference (OCUTOP minus reference) and the 95% limits of agreement, each with 95% confidence intervals, are reported and read against pre-specified clinical interpretation thresholds. The sample size of 100 evaluable participants (one analysis eye each; recruitment ceiling 150) is set by the precision of the limits of agreement. Secondary analyses cover repeatability, agreement for K1, K2 and astigmatism vectors, classification agreement at TFOS cut-offs, inter-operator reproducibility, acquisition yield, participant acceptability and clinician usability, symptom scores and safety. A Statistical Analysis Plan is signed before the first participant. The investigation is conducted under the UK Medical Devices Regulations 2002 (regulation 16) and ISO 14155:2026, with MHRA notification and Research Ethics Committee review through IRAS (370513).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-participant method-comparison and repeatability study. Every participant has both eyes measured with the investigational device and with the site reference instruments at a single visit; only the order of the instrument blocks and of the eyes is randomised.
| Arm | Type | Receives |
|---|---|---|
| OCUTOP and reference instruments | Experimental | Device: OCUTOP hand-held corneal topographer with OCUGRAPH software, Diagnostic Test: Reference instrument measurement (corneal topography and tear-film assessment)All participants. At a single visit, both eyes are measured with the OCUTOP corneal topographer (OCUGRAPH software) and with the site reference instruments (Pentacam HR, Keratograph 5M and Medmont E300 at Site 01; Myah at Site 02), in a randomised order of instrument blocks and eyes, with a rest of at least 5 minutes between blocks. Participants complete two short questionnaires. No treatment is given and there is no follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or over.
- Able to give written informed consent.
- Attending the participating clinic for any reason.
- Able to sit and fixate on a target for the duration of the measurements.
Key exclusion criteria (7 listed)
- Unable or unwilling to give informed consent.
- Active infection or inflammation of the eye or eyelids, or broken skin around the eye, at the study visit.
- Any condition that prevents the eye being kept open or the head being kept steady for the measurements (for example severe blepharospasm or nystagmus).
- Contact lens wear on the day of the visit.
- Eye surgery within the previous three months.
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 |
|---|---|---|
| OCUTOP hand-held corneal topographer with OCUGRAPH softwareInvestigational hand-held, non-contact, Placido-based corneal topographer with integrated non-invasive tear-film assessment (tear break-up time and tear meniscus height), operated through the OCUGRAPH software on a Windows computer. The device rim rests on the skin around the eye; nothing touches the eye. Both eyes are imaged at one visit, with repeat captures for repeatability. The device is not UKCA or CE marked and is labelled exclusively for clinical investigation. Manufacturer: OCUWELL Limited. | Device | OCUTOP and reference instruments |
| Reference instrument measurement (corneal topography and tear-film assessment)Corneal topography and non-invasive tear-film assessment with the CE or UKCA marked instruments in routine use at each site, used within their intended purpose: Pentacam HR (topography) and Keratograph 5M (tear film) at Site 01, with the Medmont E300 as an additional topographer; Myah (topography and tear film) at Site 02. Both eyes, same visit, repeat captures for repeatability. | Diagnostic test | OCUTOP and reference instruments |
Primary outcome
Agreement between the OCUTOP and the reference instrument for central simulated mean keratometry (K-mean)
Time frame: Single study visit (Day 1)
Mean paired difference (OCUTOP minus reference, dioptres) with 95% confidence interval, and Bland-Altman 95% limits of agreement with their 95% confidence intervals, in the analysis eye, pooled across sites and by site. Reference: Pentacam HR (Site 01), Myah (Site 02).
Agreement between the OCUTOP and the reference instrument for first non-invasive tear break-up time (NIBUT-first)
Time frame: Single study visit (Day 1)
Mean paired difference (OCUTOP minus reference, seconds) with 95% confidence interval, and Bland-Altman 95% limits of agreement with their 95% confidence intervals, in the analysis eye, pooled across sites and by site. Reference: Keratograph 5M (Site 01), Myah (Site 02).
Agreement between the OCUTOP and the reference instrument for average non-invasive tear break-up time (NIBUT-average)
Time frame: Single study visit (Day 1)
Mean paired difference (OCUTOP minus reference, seconds) with 95% confidence interval, and Bland-Altman 95% limits of agreement with their 95% confidence intervals, in the analysis eye, pooled across sites and by site. Reference: Keratograph 5M (Site 01), Myah (Site 02).
Agreement between the OCUTOP and the reference instrument for central lower tear meniscus height (TMH)
Time frame: Single study visit (Day 1)
Mean paired difference (OCUTOP minus reference, millimetres) with 95% confidence interval, and Bland-Altman 95% limits of agreement with their 95% confidence intervals, in the analysis eye, pooled across sites and by site. Reference: Keratograph 5M (Site 01), Myah (Site 02).
9 secondary outcomes
Repeatability of the OCUTOP and of each reference instrument
Time frame: Single study visit (Day 1)
Agreement for K1, K2 and the astigmatism vectors J0 and J45
Time frame: Single study visit (Day 1)
Classification agreement at TFOS cut-offs
Time frame: Single study visit (Day 1)
Inter-operator reproducibility of the OCUTOP
Time frame: Single study visit (Day 1)
Acquisition yield
Time frame: Single study visit (Day 1)
Participant acceptability and clinician usability
Time frame: Single study visit (Day 1)
Agreement and repeatability within record-defined groups
Time frame: Single study visit (Day 1)
Dry-eye symptom scores and their relation to tear-film measures
Time frame: Single study visit (Day 1)
Safety: adverse events, adverse device effects, device deficiencies and participant-reported discomfort
Time frame: Single study visit (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided. Participants are asked at consent whether anonymised data may support future research. Any sharing of de-identified individual participant data would be under a data sharing agreement with the University of Plymouth; the plan will be confirmed before study completion.
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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.
Daniela Oehring, PhD principal investigator
University of Plymouth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCUTOP hand-held corneal topographer with OCUGRAPH software and Reference instrument measurement (corneal topography and tear-film assessment) in people with Corneal Topography and Dry Eye Syndromes, run by University of Plymouth at 2 sites 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Oehring, PhD (+4417525847487, daniela.oehring@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between the OCUTOP and the reference instrument for central simulated mean keratometry (K-mean) (time frame: Single study visit (Day 1)). The study lists 4 primary outcomes in all. 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 26 Oct 2026.