RecruitingNot ApplicableNCT06839898

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

A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses to Compare Outcomes in Patients With Moderate to High Myopia and Astigmatism

Sponsor

Biotech Healthcare Holding Gmbh

Enrollment

172 participants

Start Date

Oct 10, 2021

Study Type

INTERVENTIONAL

Conditions

Myopia, Moderate Myopic Astigmatism Myopia, Degenerative

Summary

Primary Objective: To compare the efficacy and the residual refractive error of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patient with co-existing astigmatism. Secondary Objectives: To evaluate and compare the safety of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patients with co-existing astigmatism.

Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of implantable lenses (called phakic toric IOLs) placed inside the eye to correct nearsightedness and astigmatism without removing the eye's natural lens. It's aimed at people who aren't good candidates for LASIK or other surface laser procedures. **You may be eligible if...** - You are 21 years old or older - You have significant nearsightedness and astigmatism that meets the range of the lenses being tested - Your vision has been stable (not changing) for at least 12 months before surgery - You have one eye with poor uncorrected vision (6/60 or worse) **You may NOT be eligible if...** - Your cornea (front surface of the eye) is too thin or has abnormal shape - You have had previous eye surgery - Your pupil size is too large in low light - You have glaucoma, cataracts, retinal disease, or other eye conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEYECRYLTM Phakic Toric Intraocular Lens Treatment Arm

The patients will be implanted with Eyecryl Phakic IOL at this arm based on randomization.Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism.

DEVICEVisian® Toric ICL Treatment Arm

The patients will be implanted with Visian® Toric Implantable Contact Lens at this arm based on randomization. Phakic intraocular lenses are clear implantable lenses that are surgically placed either in anterior chamber (AC) or posterior chamber (PC) without removing the natural lens, enabling light to focus on the retina for improved uncorrected visual acuity. Phakic intraocular lenses demonstrate high optical quality and potential gain in visual acuity in myopic patients due to retinal magnification. Toric version of phakic intraocular lens is intended to correct both myopia and astigmatism.

Locations(4)

Precise Vision Augentagesklinik Greven

Münster, North Rhine-Westphalia, Germany

Precise Vision Augentagesklinik Rheine

Rheine, North Rhine-Westphalia, Germany

Precise Vision Augentagesklinik Rheine

Steinfurt, North Rhine-Westphalia, Germany

Netradhama Superspeciality Eye Hospital

Bangalore, Karnataka, India

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NCT06839898

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