About this trial
This single-center, prospective, cross-sectional study evaluates how accurately eight modern intraocular lens (IOL) power calculation formulas predicted the postoperative refractive result in eyes with extreme axial length after cataract surgery. Patients previously operated at the study center who had a very short (axial length \< 22.0 mm) or very long (\> 26.0 mm) eye and received a spherical monofocal IOL are invited to a single, non-invasive outcome visit. At this visit, standardized manifest refraction, optical biometry, corneal tomography, slit-lamp examination and, in long eyes, macular OCT are performed. The measured postoperative spherical equivalent is compared with the residual refraction that each of the eight formulas had predicted for the actually implanted IOL power, separately in short and long eyes. The study aims to identify which formula predicts the postoperative outcome most accurately at the extremes of axial length, where formula choice is most consequential and least well studied.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Participation in the retrospective IOL power formula comparison study at the extremes of axial length (pseudonymized study ID assigned; complete preoperative biometry and archived formula outputs for all eight formula pathways)
Cataract surgery with a spherical (non-toric) IOL of one of the three reference models (HOYA Vivinex XY1, HOYA Vivinex Impress XY1-EM, or Johnson & Johnson Tecnis 1-Piece DIB00) at the study center between January 2022 and December 2025
Preoperative axial length below 22.0 mm (short stratum) or above 26.0 mm (long stratum), measured on IOLMaster 700
Documented implanted IOL model and power available from the operative record
Disqualifiers
- Interval ocular surgery on the study eye since the original cataract surgery that may affect refraction or IOL position (e.g., corneal refractive surgery, IOL exchange or repositioning, secondary IOL implantation, or any intraocular surgery). Uncomplicated YAG laser capsulotomy without IOL repositioning is not an exclusion criterion
Implanted IOL not matching one of the three reference platforms (e.g., toric, multifocal or EDOF IOL, a different monofocal platform, or a sulcus-fixated IOL)
Toric IOL implantation
Acute ocular pathology preventing reliable refraction or biometric measurement
Trial population
Adults previously enrolled in the retrospective IOL power formula comparison study at the extremes of axial length at the study center, who underwent cataract surgery with a spherical (non-toric) monofocal IOL (HOYA Vivinex XY1, HOYA Vivinex Impress XY1-EM, or Johnson \& Johnson Tecnis 1-Piece DIB00) between January 2022 and December 2025, and whose preoperative axial length was below 22.0 mm or above 26.0 mm. A stratified random sample of 200 patients (110 short-eye, 90 long-eye) is drawn from this source cohort and invited to a single outcome visit.
Trial design
Cohort
Prospective
Treatments tested in this trial
Standardized postoperative outcome visit
Diagnostic testA single, non-invasive multimodal assessment: uncorrected and best-corrected distance visual acuity, IOLMaster 700 optical biometry, CASIA2 and Pentacam AXL corneal tomography, autorefraction and subjective manifest refraction, slit-lamp examination with posterior capsule opacification grading, and macular OCT. No therapeutic intervention, medication or surgery is performed.
Treatment groups
Trial outcomes
Primary outcomes
Spherical equivalent prediction error (SE-PE) across eight IOL power formulas, compared within each axial length stratum
For each eye, SE-PE is calculated as the measured postoperative spherical equivalent (standardized manifest refraction) minus the residual spherical equivalent predicted by each formula for the actually implanted IOL power step. The absolute prediction error (\|SE-PE\|) is compared globally across the eight formulas (Barrett Universal II, Cooke K6, EVO 2.0, Hill-RBF 3.0, Hoffer QST, Kane, PEARL-DGS, Ladas Super Formula 2.0) using the Friedman test, with post-hoc pairwise Wilcoxon signed-rank tests (Holm-corrected, 28 formula pairs), performed separately in the short (AL \< 22.0 mm) and long (AL \> 26.0 mm) strata. The primary accuracy metric per formula is the median absolute prediction error (MedAE).
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