Trial · NCT07895849
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
NCT07895849, Not applicable, Not yet recruiting, University of Plymouth
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Performance Evaluation of the OCUTOP Hand-held Corneal Topographer. Trials, record NCT07895849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07895849
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
- NCT number
- NCT07895849
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 150 participants, estimated
- Lead sponsor
- University of Plymouth
- Conditions
- Corneal Topography, Dry Eye Syndromes, Keratoconus, Healthy Volunteers
- Interventions
- OCUTOP hand-held corneal topographer with OCUGRAPH software, Reference instrument measurement (corneal topography and tear-film assessment)
- First posted
- 2026-10-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Agreement between the OCUTOP and the reference instrument for central simulated mean keratometry (K-mean) | 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). |
| Primary | Agreement between the OCUTOP and the reference instrument for first non-invasive tear break-up time (NIBUT-first) | 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). |
| Primary | Agreement between the OCUTOP and the reference instrument for average non-invasive tear break-up time (NIBUT-average) | 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). |
| Primary | Agreement between the OCUTOP and the reference instrument for central lower tear meniscus height (TMH) | 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). |
| Secondary | Repeatability of the OCUTOP and of each reference instrument | Single study visit (Day 1) | 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. |
| Secondary | Agreement for K1, K2 and the astigmatism vectors J0 and J45 | Single study visit (Day 1) | 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. |
| Secondary | Classification agreement at TFOS cut-offs | Single study visit (Day 1) | 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. |
| Secondary | Inter-operator reproducibility of the OCUTOP | Single study visit (Day 1) | 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. |
| Secondary | Acquisition yield | Single study visit (Day 1) | Proportion of OCUTOP captures and videos rated unusable, overall and by site, reporting group and operator. |
| Secondary | Participant acceptability and clinician usability | Single study visit (Day 1) | 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). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07895849
GET https://conductscience.org/api/trials/v1/NCT07895849/registered