IOL Power Formula Prediction Accuracy at the Extremes of Axial Length: A Prospective Outcome Verification Study

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Clinical Outcomes of Formula-dependent IOL Power Selection at the Extremes of Axial Length: a Cross-sectional Outcome Verification of Seven ESCRS-hosted Formulas and the Ladas Super Formula 2.0 in Short (<22.0 mm) and Long (>26.0 mm) Eyes Using Refractive, Biometric, and Tomographic Assessment

Conditions

Pseudophakia, Refractive Error

Being tested

Standardized postoperative outcome visit

Keywords

Intraocular lens power calculation, IOL formula, Axial length, Short eye, Long eye

Medical subject headings

Pseudophakia, Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Standardized postoperative outcome visitDiagnostic test

  A 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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).

   Measured: Single study visit, at least 3 months after cataract surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted24 Jul 2026
2. Study start1 Aug 2026 (estimated)
3. Primary completion1 Jun 2027 (estimated)
4. Study completion1 Jul 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for PseudophakiaStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.