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
Qualifiers
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
Treatments tested in this trial
- EYECRYLTM Phakic Toric Intraocular Lens Treatment Arm
- Visian® Toric ICL Treatment Arm
Treatment groups
172 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov