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

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

Inclusion Criteria:

* Patients 21 years old or older.
* Calculated IOL Power is within the range of the investigational IOLs
* Corneal Cylindrical error within the range defined in the clinical investigation plan
* Subject has monocular UCVA 0.5 LogMAR or worse
* Subject has had a stable refraction (±0.5D; ±1.0D for higher refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history.
* Subject, who is a current contact lens wearer, needs to demonstrate a stable refraction (±0.5D) expressed as MRSE, on two consecutive examination dates and stability of the refraction is determined by the following criteria:

  1. Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction.
  2. Two refractions were performed at least 7 days apart.
* Subject, who is expected to have residual postoperative cylindrical refractive error of ≥1D, has been given the opportunity to experience his/her best spectacle vision with the anticipated correction.
* Expected dilated pupil size at least large enough to visualize the axis marking.
* Patients willing to attend all follow-up appointments
* Patients must sign and be given a copy of the written Informed Consent form

Exclusion Criteria:

* Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation.
* Subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject
* Subject with ocular condition that may predispose the subject to future complications
* Subject with previous intraocular or corneal surgery
* Subject with less than the minimum endothelial cell density 2000 cells/mm² at the time of enrollment
* Pregnant or planning to become pregnant, or is lactating during the course of the evaluation
* Other condition associated with fluctuation of hormones
* ACD measured from the endothelium lower than 2.8 mm
* Concurrent participation in another drug or device evaluation.
* Any cataract of any grade.
* Coefficient of variation of endothelial cell area \>0.45
* Percent Hexagonality of endothelial cell shape ≤ 45%
* Monocular subject
* Vulnerable subjects as defined in section 12.3.10

Conditions4

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