MedTrace Logo

Postoperative Outcomes of a Toric AddOn Intraocular Lens After Keratoplasty and Cataract Surgery

NCT07452042 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-03-05

No results posted yet for this study

Summary

The aim of this clinical study is to evaluate a toric add-on intraocular lens (IOL) for the correction of high astigmatism in patients who have undergone keratoplasty and cataract surgery. As this patient group often suffers from significant preoperative residual astigmatism, there is a relevant clinical need for effective and safe refractive treatment options. The implantation of a toric add-on IOL in the ciliary sulcus is intended to significantly reduce postoperative astigmatism and improve visual rehabilitation.

The study is designed as a prospective, monocentric clinical trial with a limited number of cases, as this is a rare condition with limited availability of suitable patients. It is being conducted in accordance with Section 3 of the Austrian Medical Devices Act (MPG 2021) and is investigating a CE-marked add-on intraocular lens implant used within its intended purpose. The postoperative refractive cylinder serves as the primary endpoint, as it reflects the actual effectiveness of astigmatism correction. The rotational stability of the add-on IOL, which significantly influences refractive precision, is recorded as a secondary endpoint.

All study participants will be examined pre- and postoperatively in accordance with applicable medical standards. The results should contribute to the optimization of refractive care after keratoplasty and assess the clinical applicability of toric AddOn IOLs in this specific indication.

Conditions

  • Cataract and IOL Surgery
  • Keratoplasty
  • Toric Intraocular Lens Stability

Interventions

PROCEDURE

AddOn toric IOL implantation

Implantation of a toric AddOn IOL in the ciliary sulcus of patients after cataract surgery and keratoplasty with a high postoperative refractive cylinder.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Eligibility

Min Age
45 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2029-02-28
Completion
2029-02-28

Countries

  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07452042 on ClinicalTrials.gov