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

Study results available
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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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05985304 on ClinicalTrials.gov