Trial · NCT07895849
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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). |
| Secondary | Agreement and repeatability within record-defined groups | Single study visit (Day 1) | 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). |
| Secondary | Dry-eye symptom scores and their relation to tear-film measures | Single study visit (Day 1) | 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. |
| Secondary | Safety: adverse events, adverse device effects, device deficiencies and participant-reported discomfort | Single study visit (Day 1) | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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