A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses
Condition(s) studied
Investigational drug(s) / intervention(s)
EYECRYLTM 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.
Visian® 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.
Study 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
Primary outcome measure(s)
- The mean residual refractive error — 6 Month
The mean residual refractive error in the study lens population that is equivalent to the mean residual refractive error of the control lens within +/- 0.50 Diopters at the 6-months post-op visit.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Precise Vision Augentagesklinik Greven | Münster | North Rhine-Westphalia | Recruiting |
| Precise Vision Augentagesklinik Rheine | Rheine | North Rhine-Westphalia | Recruiting |
| Precise Vision Augentagesklinik Rheine | Steinfurt | North Rhine-Westphalia | Recruiting |
| Netradhama Superspeciality Eye Hospital | Bangalore | Karnataka | Recruiting |
More Biotech Healthcare Holding Gmbh trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06839898 on ClinicalTrials.gov ↗ ← All trials in Germany