A prospective, randomized clinical study of two phakic toric implantable lenses to compare outcomes in patients with moderate to high myopia and astigmatism - BTVCPL-PHAKICTORIC-2019-13

Biotech Healthcare Holdings GmbH0 sites86 target enrollmentAugust 2, 2021

Overview

No summary available.

Registry

who.int

Start Date

August 2, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Biotech Healthcare Holdings GmbH

•1\. Patients 21 years old or older.
•2\. Calculated IOL Power is within the range of the investigational IOLs
•3\. Corneal Cylindrical error within the range defined in the clinical investigation plan
•4\. Subject has monocular UCVA 0\.5 LogMAR or worse
•5\. 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.
•6\. 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:
•a. Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction.
•b. Two refractions were performed at least 7 days apart.
•7\. 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.

•1\. Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation.
•2\. Subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject
•3\. Subject with ocular condition that may predispose the subject to future complications
•4\. Subject with previous intraocular or corneal surgery
•5\. Subject with less than the minimum endothelial cell density 2000 cells/mm² at the time of enrollment
•6\. Pregnant or planning to become pregnant, or is lactating during the course of the evaluation
•7\. Other condition associated with fluctuation of hormones
•8\. ACD measured from the endothelium lower than 2\.8 mm
•9\. Concurrent participation in another drug or device evaluation.
•10\. Any cataract of any grade.