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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorVienna Hospital Association

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 volunteers

Qualifiers

- 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standardized postoperative outcome visit

    Diagnostic 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Short axial length stratum (AL < 22.0 mm)1 intervention
Group B: Long axial length stratum (AL > 26.0 mm)1 intervention

Trial outcomes

Primary outcomes

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).

Time frame
Single study visit, at least 3 months after cataract surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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