An interventional study of OCUTOP hand-held corneal topographer with OCUGRAPH software and Reference instrument measurement (corneal topography and tear-film assessment) in Corneal Topography, Dry Eye Syndromes and Keratoconus, sponsored by University of Plymouth. Not yet recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by University of Plymouth · Not applicable, Interventional, and Diagnostic
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.
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).
1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →University of Plymouth is the lead sponsor of 49 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
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.
Device: OCUTOP hand-held corneal topographer with OCUGRAPH software · Diagnostic Test: Reference instrument measurement (corneal topography and tear-film assessment)
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.
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.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Single study visit (Day 1)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Single study visit (Day 1)
Acquisition yield
Proportion of OCUTOP captures and videos rated unusable, overall and by site, reporting group and operator.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Single study visit (Day 1)
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Mar 2027, 2 months later.
Of 185 non-industry interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 25. This study's planned 2 months is below that.
Counting every sponsor, half of 293 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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