Trial · NCT07880249
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
NCT07880249, Not yet recruiting, Vienna Hospital Association
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery. Trials, record NCT07880249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07880249
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
- NCT number
- NCT07880249
- Status
- Not yet recruiting
- Enrollment
- 128 participants, estimated
- Lead sponsor
- Vienna Hospital Association
- Conditions
- Cataract
- Interventions
- Standardized Postoperative Outcome Visit, Toric IOL Calculator Pathways (Exposure)
- First posted
- 2026-10-19
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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/NCT07880249
GET https://conductscience.org/api/trials/v1/NCT07880249/registered