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NCT07880249

Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery

Sponsor: Vienna Hospital Association

View on ClinicalTrials.gov

Summary

The goal of this observational study is to learn which toric lens calculator best predicts the astigmatism remaining after cataract surgery in adults who received a TECNIS DIU toric intraocular lens (IOL) at Klinik Hietzing, Vienna, between January 2023 and March 2026. Toric lenses correct astigmatism (an uneven curvature of the cornea) during cataract surgery. The strength of the lens and its orientation in the eye are chosen with online calculators. In an earlier study of the same patients, two widely used calculators - the Johnson \& Johnson toric calculator and the Barrett calculator of the European Society of Cataract and Refractive Surgeons (ESCRS) - recommended different lenses in about 6 out of 10 eyes. It is not known which recommendation leads to the better result. The main questions it aims to answer are: 1. In eyes in which the two calculators disagreed, which calculator predicted the astigmatism after surgery more accurately? 2. How accurate are four further calculator options, and did the toric lenses stay in their planned position? Researchers will compare the astigmatism that each calculator predicted for the lens that was actually implanted with the astigmatism measured after surgery. Participants will: 1. Attend one examination visit of about 60 to 90 minutes, at least 3 months after their cataract surgery 2. Have standard eye examinations: a vision test, a test for glasses (refraction), and several painless optical scans that do not touch the eye 3. Have the eye examined at the slit lamp; drops to widen the pupil are given only at the end of the visit, if needed, to check the position of the lens No treatment, medication or surgery is given as part of this study.

Official title: Clinical Outcomes of Calculator-Dependent Toric IOL Planning: A Cross-Sectional Outcome Verification of ESCRS Toric Engines and the Johnson & Johnson Toric Calculator Using Refractive, Tomographic, and Ray-Tracing Aberrometric Assessment

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

128

Start Date

2026-11-01

Completion Date

2027-03

Last Updated

2026-10-19

Healthy Volunteers

No

Conditions

Interventions

OTHER

Standardized Postoperative Outcome Visit

Single non-invasive examination visit (approximately 60-90 minutes), at least 3 months after cataract surgery, in a fixed sequence: uncorrected distance visual acuity, ray-tracing wavefront aberrometry (iTrace), optical biometry (IOLMaster 700), anterior segment OCT tomography (CASIA2), Scheimpflug tomography (Pentacam AXL), autorefraction and standardized manifest refraction with best-corrected distance visual acuity, and slit-lamp examination with posterior capsule opacification grading, toric IOL axis documentation by retroillumination and assessment of centration and tilt. Pupil dilation only after completion of all pupil-dependent measurements. No study-related treatment, medication or surgery.

OTHER

Toric IOL Calculator Pathways (Exposure)

Archived preoperative toric planning outputs of six calculator pathways, generated from a standardized input set in the preceding retrospective study: Johnson \& Johnson toric calculator with posterior corneal astigmatism correction enabled (PCA-ON) and disabled (PCA-OFF), and the ESCRS toric calculator with the Barrett, Kane, EVO 2.0 and Hoffer QST engines. The residual astigmatism predicted for the actually implanted toric step is compared with the measured postoperative outcome. No treatment is assigned within this study; all lenses were implanted during routine care.