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

Sponsor
Rayner Intraocular Lenses Limited (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02378636
Collaborator
Visioncare Research Limited (Other)
125
Enrollment
1
Location
1
Arm
26
Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 600S
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
125 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Investigation of the Modified Rayner Monofocal Aspheric 600C (With Axis Marks) Intraocular Lens
Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Jan 1, 2016
Anticipated Study Completion Date :
Aug 1, 2017

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Best Corrected Distance Visual Acuity (BCDVA) [180 Day]

      Best Corrected Distance Visual Acuity

    2. Rotational Stability [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Contact Rayner Intraocular Lenses Limited for Locations Hove East Sussex United Kingdom BN3 7AN

    Sponsors and Collaborators

    • Rayner Intraocular Lenses Limited
    • Visioncare Research Limited

    Investigators

    • Study Chair: Mark Packer, MD, Consultant

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rayner Intraocular Lenses Limited
    ClinicalTrials.gov Identifier:
    NCT02378636
    Other Study ID Numbers:
    • 600C-EU-401
    • CFLX-2501
    First Posted:
    Mar 4, 2015
    Last Update Posted:
    Jun 12, 2015
    Last Verified:
    Jun 1, 2015
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Jun 12, 2015