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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02378636
Recruitment Status : Unknown
Verified June 2015 by Rayner Intraocular Lenses Limited.
Recruitment status was:  Not yet recruiting
First Posted : March 4, 2015
Last Update Posted : June 12, 2015
Visioncare Research Limited
Information provided by (Responsible Party):
Rayner Intraocular Lenses Limited

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
Cataract Device: 600S Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
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 : June 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: 600S
Modified 600C (axis marks) monofocal aspheric intraocular lens
Device: 600S
Monofocal Aspheric Intraocular Lens (IOL)
Other Name: Modified 600C (axis marks)

Primary Outcome Measures :
  1. Best Corrected Distance Visual Acuity (BCDVA) [ Time Frame: 180 Day ]
    Best Corrected Distance Visual Acuity

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02378636

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Contact: Paul Rice +44 (0) 1273 205401
Contact: Juliette Cook +44 (0) 1273 205401

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United Kingdom
Contact Rayner Intraocular Lenses Limited for Locations Not yet recruiting
Hove, East Sussex, United Kingdom, BN3 7AN
Contact: Paul Rice    +441273205401   
Contact: Juliette Cook    +441273205401   
Sponsors and Collaborators
Rayner Intraocular Lenses Limited
Visioncare Research Limited
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Study Chair: Mark Packer, MD Consultant

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Responsible Party: Rayner Intraocular Lenses Limited Identifier: NCT02378636     History of Changes
Other Study ID Numbers: 600C-EU-401
CFLX-2501 ( Other Identifier: CRO Reference )
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases