Trial · NCT07880249
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Paired Difference in Alpins Difference Vector Magnitude Between the J&J Toric Calculator (PCA-ON) and ESCRS-Barrett in Eyes With Clinically Relevant Planning Discrepancy | Single outcome visit, at least 3 months after cataract surgery | For each eye, the difference vector (DV) is the vector difference (J0/J45 power-vector space) between the residual astigmatism predicted by a calculator for the actually implanted TECNIS DIU toric step and the residual refractive astigmatism measured by standardized manifest refraction (plus-cylinder notation). The paired difference is \|DV J\&J PCA-ON\| minus \|DV Barrett\| (diopters); negative values favor J\&J, positive values favor Barrett. Population: eyes with clinically relevant planning discrepancy (ClinRel = 1: toric step difference ≥1 and/or axis difference ≥10° between the two calculators), one eye per patient. Primary result: mean paired difference with two-sided 95% confidence interval, interpreted against a pre-specified zone of practical equivalence of ±0.125 D; stratified by astigmatism phenotype (with-the-rule, against-the-rule, oblique). |
| Secondary | Prediction Accuracy of Six Toric Calculator Pathways (Difference Vector Magnitude) | Single outcome visit, at least 3 months after cataract surgery | Magnitude of the Alpins difference vector (D) between the residual astigmatism predicted for the implanted toric step and the manifest refractive astigmatism, for J\&J PCA-ON, J\&J PCA-OFF, ESCRS-Barrett, ESCRS-Kane, ESCRS-EVO 2.0 and ESCRS-Hoffer QST; mean ± SD and median \[IQR\]; pairwise within-eye comparisons of all 15 pathway pairs (Friedman test, Holm-corrected Wilcoxon signed-rank tests); full cohort and by ClinRel status and astigmatism phenotype. Alpins magnitude of error, angle of error and correction index are reported once per eye. |
| Secondary | Proportion of Eyes With Difference Vector Magnitude ≤0.50 D and ≤0.25 D per Calculator Pathway | Single outcome visit, at least 3 months after cataract surgery | Percentage of eyes with an Alpins difference vector magnitude ≤0.50 D and ≤0.25 D for each of the six calculator pathways, with Wilson 95% confidence intervals; pairwise comparisons between pathways with McNemar tests. |
| Secondary | Residual Refractive Astigmatism in J&J-Concordant Versus Barrett-Concordant Eyes (ClinRel = 1) | Single outcome visit, at least 3 months after cataract surgery | Manifest refractive cylinder (D) in ClinRel = 1 eyes in which the implanted toric step matched the J\&J PCA-ON recommendation versus eyes in which it matched the Barrett recommendation; Mann-Whitney U test and linear regression adjusted for anterior and posterior corneal astigmatism, astigmatism phenotype, IOL misalignment, posterior capsule opacification grade and time since surgery. Formal comparison only if each group contains ≥10 eyes. |
| Secondary | Postoperative Residual Refractive Astigmatism | Single outcome visit, at least 3 months after cataract surgery | Manifest refractive cylinder (D, plus-cylinder notation), axis (degrees) and J0/J45 vector components; proportions of eyes with ≤0.50 D, ≤0.75 D and ≤1.00 D; full cohort and ClinRel = 1 versus ClinRel = 0 eyes (unadjusted and confounder-adjusted). |
| Secondary | Uncorrected and Best-Corrected Distance Visual Acuity | Single outcome visit, at least 3 months after cataract surgery | Uncorrected (UDVA) and best-corrected distance visual acuity (BCDVA) in logMAR, measured monocularly with Snellen optotypes at 6 m; proportions of eyes with ≤0.10 logMAR and ≤0.30 logMAR; correlation between residual refractive cylinder and UDVA. |
| Secondary | Toric IOL Rotational Stability | Single outcome visit, at least 3 months after cataract surgery | Angular deviation (degrees) between the documented intended implantation axis and the measured postoperative toric IOL axis (slit-lamp retroillumination; CASIA2 as secondary method); proportions of eyes with ≥5° and ≥10° misalignment; association between misalignment and residual refractive astigmatism. |
| Secondary | Measured Versus Assumed Surgically Induced Astigmatism | Single outcome visit, at least 3 months after cataract surgery | Corneal surgically induced astigmatism (D, degrees), computed as the vector difference between preoperative and postoperative CASIA2 anterior corneal astigmatism (Pentacam AXL as secondary method), compared with the planning assumption of 0.40 D at 135°: magnitude error, angle error and difference vector; association with calculator difference vector magnitude. |
| Secondary | Corneal Stability Between Preoperative and Postoperative Measurement | Single outcome visit, at least 3 months after cataract surgery | Change in CASIA2 anterior corneal astigmatism magnitude (D) and axis (degrees) between the preoperative and the postoperative measurement within the same analysis zone; proportion of eyes classified as cornea stable (change \<0.50 D and \<15°) with Wilson 95% confidence interval. |
| Secondary | Inter-Device Agreement for Postoperative Total Corneal Astigmatism | Single outcome visit, at least 3 months after cataract surgery | Agreement between IOLMaster 700 total keratometry, CASIA2 real corneal astigmatism and Pentacam AXL total corneal refractive power: Bland-Altman mean bias and 95% limits of agreement for magnitude, J0 and J45; intraclass correlation coefficients; proportion of eyes with an inter-device difference ≥0.50 D. |
| Secondary | Wavefront-Derived Astigmatism Decomposition and Higher-Order Aberrations (iTrace) | Single outcome visit, at least 3 months after cataract surgery | Total ocular, corneal and internal astigmatism (magnitude, axis); higher-order aberration RMS, coma, trefoil and spherical aberration at 3.0 mm pupil diameter; Dysfunctional Lens Index; agreement between iTrace total ocular astigmatism and manifest refractive cylinder. |
| Secondary | Proportion of ClinRel = 1 Eyes in Which the J&J Calculator Was More Accurate Than Barrett | Single outcome visit, at least 3 months after cataract surgery | Proportion of ClinRel = 1 eyes in which the difference vector magnitude of J\&J PCA-ON was smaller than that of Barrett, with Wilson 95% confidence interval and exact binomial test against 50%. |
| Secondary | Agreement of Calculator Recommendations With the Retrodictively Optimal Toric Step | Single outcome visit, at least 3 months after cataract surgery | Proportion of eyes in which each calculator's recommended toric step matched the step that would have produced the lowest residual astigmatism based on the measured postoperative outcome, with Wilson 95% confidence intervals and Holm-corrected McNemar tests between pathways. Exploratory analysis. |
| Secondary | Association Between J&J Decision Margin and Postoperative Outcome | Single outcome visit, at least 3 months after cataract surgery | Association between the J\&J PCA-ON decision margin (difference in predicted residual astigmatism between the recommended and the best alternative toric step; \<0.10 D versus ≥0.10 D) and residual refractive cylinder and J\&J difference vector magnitude (Spearman correlation, Mann-Whitney U test, adjusted linear regression). |
| Secondary | Predictors of Suboptimal Refractive Outcome | Single outcome visit, at least 3 months after cataract surgery | Adjusted odds ratios with 95% confidence intervals from multivariable logistic regression for a suboptimal outcome (residual refractive cylinder \>0.50 D and/or difference vector magnitude \>0.50 D). Candidate predictors: posterior corneal astigmatism, astigmatism phenotype, ClinRel status, J\&J decision margin, IOL misalignment, corneal stability, posterior capsule opacification grade, axial length and time since surgery. A reduced model is used if there are fewer than 10 events per predictor; Firth-penalized regression if separation occurs. |
| Secondary | Evaluability per Calculator Pathway | Single outcome visit, at least 3 months after cataract surgery | Proportion of eyes evaluable for the difference vector computation per calculator pathway (predicted residual astigmatism for the implanted step available from the archived or a retrospectively reconstructed output), reasons for non-evaluability, and number of reconstructive calculator runs per engine. |
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.
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