Clinical Trial of a Hydrophilic EMV Toric Lens RAO210T in the Correction of Aphakia and Corneal Astigmatism
NCT05985304 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 274
Last updated 2026-01-21
Summary
The objectives of the clinical investigation are to determine the safety and performance of the RayOne EMV Toric (Model RAO210T) following unilateral implantation and approximately 6 months (120 to 180 days) of post-operative assessment, as a randomized comparison to aspheric monofocal control for low cylinder (1.50 D). This patient population with cataracts and low corneal cylinder (+1.00 to +1.50 D) will have the natural crystalline lens removed and replaced with an intraocular lens in the capsular bag.
Conditions
- Cataract
- Corneal Astigmatism
Interventions
- DEVICE
-
RayOne EMV Toric IOL
Implantation of intraocular lens.
- DEVICE
-
RayOne Monofocal IOL
Implantation of intraocular lens.
- PROCEDURE
-
Cataract Surgery
Removal of natural crystalline lens due to cataracts
Sponsors & Collaborators
-
Rayner Intraocular Lenses Limited
lead INDUSTRY
Principal Investigators
-
Mark Packer, MD
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-10
- Primary Completion
- 2024-10-23
- Completion
- 2024-10-23
- FDA Device
- Yes
Countries
- United States
Study Locations
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