Toric add-on lens to reduce astigmatism after corneal transplant and cataract surgery
Postoperative Outcomes of a Toric Add-On Intraocular Lens After Keratoplasty and Cataract Surgery
This will try a toric add-on lens placed in the eye’s sulcus to reduce persistent high astigmatism in people who have had keratoplasty and cataract surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 95 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT07452042 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center clinical assessment of a CE-marked toric add-on intraocular lens implanted in the ciliary sulcus of pseudophakic patients after keratoplasty and cataract surgery. The study enrolls a limited number of cases because the condition and candidate pool are uncommon, and follows patients postoperatively to measure refractive cylinder as the primary outcome. Procedures are performed at the Medical University of Vienna under the Austrian Medical Devices Act (MPG 2021) using the device within its intended purpose. The investigators aim to document reduction in corneal astigmatism and visual rehabilitation while monitoring lens stability and safety outcomes.
Who should consider this trial
Good fit: Ideal candidates are pseudophakic adults (45–90 years) who had uncomplicated keratoplasty and cataract surgery, have regular postoperative corneal astigmatism greater than 1.0 D, and dilate to a pupil diameter >5.5 mm.
Not a fit: Patients with uncontrolled glaucoma, proliferative diabetic retinopathy, iris neovascularization, active or recurrent uveitis/iritis, microphthalmus, other uncontrolled ocular or systemic disease, blindness in the fellow eye, or who are pregnant or breastfeeding are excluded and unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the implant could substantially reduce residual postoperative astigmatism and improve visual rehabilitation for affected patients, potentially decreasing the need for further corneal procedures.
How similar studies have performed: Small case series and reports of toric add-on IOLs placed in the sulcus have shown reductions in residual astigmatism and improved vision, but larger controlled data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Vienna, State of Vienna
- Medical University of Vienna, Department of Ophthalmology and Optometry — Vienna, State of Vienna, Austria (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.