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ID06839898

Comparing Two Phakic Toric Implantable Lenses for Treating Moderate to High Myopia with Astigmatism

Led by Biotech Healthcare Holding Gmbh · Updated on 2025-02-21

172

Participants Needed

4

Research Sites

78 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to compare the effectiveness and remaining refractive error of two types of phakic toric intraocular lenses in patients with moderate to high myopia and astigmatism. The study also evaluates and compares the safety of the EYECRYLTM Phakic Toric lens versus the Visian4 Toric Implantable Contact Lens in this patient group. Phakic intraocular lenses are clear lenses surgically placed in the eye without removing the natural lens, helping to improve uncorrected vision by focusing light correctly on the retina. Participants will be randomly assigned to receive one of two treatments the Eyecryl Phakic Toric intraocular lens or the Visian4 Toric Implantable Contact Lens. Both lenses are designed to correct myopia and astigmatism and are implanted either in the anterior or posterior chamber of the eye. The study involves surgical placement of these lenses to assess their performance and safety over time. During the study, participants will attend all scheduled follow-up visits to monitor visual outcomes and safety. Researchers will measure the mean residual refractive error six months after lens implantation as the primary outcome. Safety assessments and other evaluations will also be conducted to track the lenses effects. The study started in October 2021 and is expected to continue until February 2027, with ongoing monitoring of participants vision and eye health.

CONDITIONS

Brief Title

A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses

Research Team

B

BHARGAV D JOSHI, M.Sc.

H

Hatice B Deveci Summer, B.Sc

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