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

NCT07452042 | Recruiting

• 1 other identifier: 1710/2025
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean Postoperative Refractive Cylinder (Diopters)

  The primary endpoint is the proportion of eyes achieving a ≥50% reduction in refractive cylinder postoperatively at the last visit (4 - 7 months). The postoperative refractive cylinder will be assessed by subjective refraction using a Snellen chart at 6 m. A one-sided exact binomial test (α = 0.05) will be used to determine if this proportion is greater than 70%. The 90% two-sided Clopper-Pearson confidence interval will also be reported.

  4-7 months

Secondary Outcomes (4)

• Mean Absolute IOL Rotation from Intended Axis (Degrees)

  4-7 months

• Mean IOL Decentration (Millimeters)

  4-7 months

• Mean IOL Tilt (Degrees)

  4-7 months

• Mean Axial Position Change of IOL (Millimeters)

  4-7 months

Interventions

AddOn toric IOL implantation PROCEDURE

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

Eligibility Criteria

• Age: 45 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for add-on toric intraocular lens (IOL) implantation due to high postoperative refractive cylinder after keratoplasty and cataract surgery at the University Department of Ophthalmology and Optometry are screened during the preoperative examination. Interested patients are informed about the study's objectives and procedures and, upon consent, are enrolled.

You may qualify if:

• Gender: female, male, or diverse
• Ophthalmological diagnosis: pseudophakic patients after keratoplasty
• Age: 45 to 90 years
• Complication-free cataract surgery using phacoemulsification and implantation of a posterior chamber lens.
• Complication-free keratoplasty and regular postoperative corneal astigmatism \> 1 diopter (D)
• Pupil diameter in mydriasis \> 5.5 mm

You may not qualify if:

• Uncontrolled glaucoma
• Proliferative diabetic retinopathy
• Iris neovascularization
• History of uveitis or iritis
• Microphthalmus
• Recurrent intraocular inflammation of unknown cause
• Blindness in the other eye
• Uncontrolled systemic or ocular disease
• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Ophthalmology and Optometry

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: March 5, 2026

Record last verified: 2026-02

Locations

AU (1)