A Prospective, Randomized Clinical Study of Two Phakic Toric Implantable Lenses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorBiotech Healthcare Holding Gmbh
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm
DeviceThe 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
DeviceThe 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.
Treatment groups
172 Participants
are divided into 2 treatment groupsGroup A: EYECRYLTM Phakic Toric Intraocular Lens Treatment ArmExperimental treatment 1 intervention
Group B: Visian® Toric ICL Treatment ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The mean residual refractive error
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.
Time frame
6 MonthSponsors and contacts
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Source ClinicalTrials.gov