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

Recruiting now · Not applicable

Conditions studied: Myopia, Moderate, Myopic Astigmatism, Myopia, Degenerative

In brief

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.

Key facts

Study ID: NCT06839898
Run by: Biotech Healthcare Holding Gmbh
People needed: 172
Starts: 2021-10-10
Expected to finish: 2027-02-01
Last updated by the study team: 2025-02-21

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction.
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

You may not qualify if…

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

Where it is running

Precise Vision Augentagesklinik Greven — Münster, North Rhine-Westphalia, Germany (enrolling)
Precise Vision Augentagesklinik Rheine — Rheine, North Rhine-Westphalia, Germany (enrolling)
Precise Vision Augentagesklinik Rheine — Steinfurt, North Rhine-Westphalia, Germany (enrolling)
Netradhama Superspeciality Eye Hospital — Bangalore, Karnataka, India (enrolling)

Full record on ClinicalTrials.gov

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