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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Visioncare Research Limited
Information provided by (Responsible Party):
Rayner Intraocular Lenses Limited

Tracking Information
First Submitted Date  ICMJE February 19, 2015
First Posted Date  ICMJE March 4, 2015
Last Update Posted Date June 12, 2015
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2015)
  • Best Corrected Distance Visual Acuity (BCDVA) [ Time Frame: 180 Day ]
    Best Corrected Distance Visual Acuity
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02378636 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Investigation of the Modified Rayner Monofocal Aspheric 600C (With Axis Marks) Intraocular Lens
Official Title  ICMJE Clinical Investigation of the Modified Rayner Monofocal Aspheric 600C (With Axis Marks) Intraocular Lens
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE Device: 600S
Monofocal Aspheric Intraocular Lens (IOL)
Other Name: Modified 600C (axis marks)
Study Arms  ICMJE Experimental: 600S
Modified 600C (axis marks) monofocal aspheric intraocular lens
Intervention: Device: 600S
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 26, 2015)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2017
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02378636
Other Study ID Numbers  ICMJE 600C-EU-401
CFLX-2501 ( Other Identifier: CRO Reference )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rayner Intraocular Lenses Limited
Study Sponsor  ICMJE Rayner Intraocular Lenses Limited
Collaborators  ICMJE Visioncare Research Limited
Investigators  ICMJE
Study Chair: Mark Packer, MD Consultant
PRS Account Rayner Intraocular Lenses Limited
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP