Toric add-on lens to reduce astigmatism after corneal transplant and cataract surgery
Official title: Postoperative Outcomes of a Toric Add-On Intraocular Lens After Keratoplasty and Cataract Surgery
Run by Medical University of Vienna · NCT07452042 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 45 Years to 95 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Status | Recruiting |
| Started | August 27, 2026 |
| Main results expected | February 2029 |
| Study ends | February 2029 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT07452042 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gender: female, male, or diverse * Ophthalmological diagnosis: pseudophakic patients after keratoplasty * Age: 45 to 95 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 it's running
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Medical University of Vienna, Department of Ophthalmology and Optometry
Vienna, State of Vienna, Austria Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.