Clinical Investigation of the Modified Rayner Monofocal Aspheric 600C (With Axis Marks) Intraocular Lens

November 20, 2023 updated by: Rayner Intraocular Lenses Limited
This will be a prospective, open-label, 125 subject (maximum), two-year multicentre investigation to assess the safety, effectiveness and rotational stability of the modified 600C (axis marks) intraocular lens (IOL) in subjects undergoing cataract extraction.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • East Sussex
      • Hove, East Sussex, United Kingdom, BN3 7AN
        • Contact Rayner Intraocular Lenses Limited for Locations
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female aged ≥21 years of age.
  • Cataract for which phacoemulsification extraction and posterior IOL implantation has been planned for the operative eye.
  • Best corrected distance visual acuity (BCDVA) projected to be better than 20/30 (+0.18 logMAR) in the operative eye after cataract removal and IOL implantation.
  • Calculated IOL power requirement within the range +8.0 to +34.0D
  • If present, subject must have corneal astigmatism of <1.50 D in the operative eye.
  • Expected dilated pupil size ≥ 5.0 mm in diameter to visualise the axis markings
  • Subject must provide written informed consent.
  • Subject must be able to return for scheduled follow-up examinations for 24 months after surgery.

Exclusion Criteria:

  • History of ocular trauma or prior ocular surgery in the operative eye.
  • Microphthalmia
  • Corneal decompensation or endothelial insufficiency
  • Pseudo exfoliation
  • Pars planitis
  • Subjects with diagnosed degenerative visual disorders in the operative eye (e.g.,macular degeneration or other retinal disorders) that are predicted to cause future visual acuity losses to a level of 20/30 (+0.18 logMAR) or worse.
  • Inability to achieve secure placement in the designated location e.g. absence of a secure peripheral anterior capsule, zonule laxity or dehiscence; posterior synechiae to the capsular bag
  • Active ocular disease in the operative eye, e.g., clinically significant dystrophy, chronic severe uveitis, proliferative diabetic retinopathy, or chronic glaucoma.
  • Concurrent participation in another drug or device investigation.
  • Patients who are expected to require retinal laser treatment.
  • Females who are pregnant, nursing or plan to become pregnant during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 600S
Modified 600C (axis marks) monofocal aspheric intraocular lens
Device: 600S
Monofocal Aspheric Intraocular Lens (IOL)
Other Names:
  • Modified 600C (axis marks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Corrected Distance Visual Acuity (BCDVA)
Time Frame: 180 Day
Best Corrected Distance Visual Acuity
180 Day
Rotational Stability
Time Frame: 180 Day
IOL rotation will be measured through retro-illumination photography between 0-3 hours post-operatively and this will be compared with images from Day 120-180 to determine degree of IOL rotation in accordance with ISO-11979-7:2014 requirements
180 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rayner Intraocular Lenses Limited

Collaborators

Visioncare Research Ltd.

Investigators

  • Study Chair: Mark Packer, MD, Consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Estimated)

January 1, 2016

Study Completion (Estimated)

August 1, 2017

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

February 26, 2015

First Posted (Estimated)

March 4, 2015

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 600C-EU-401
  • CFLX-2501 (Other Identifier: CRO Reference)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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