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

NCT02378636 | Withdrawn

• 2 other identifiers: 600C-EU-401CFLX-2501
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

• Best Corrected Distance Visual Acuity (BCDVA)

  Best Corrected Distance Visual Acuity

  180 Day

• Rotational Stability

  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

Study Arms (1)

600S

EXPERIMENTAL

Modified 600C (axis marks) monofocal aspheric intraocular lens

Device: 600S

Interventions

600S DEVICE

Monofocal Aspheric Intraocular Lens (IOL)

Also known as: Modified 600C (axis marks)

600S

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rayner Intraocular Lenses Limited: lead
• Visioncare Research Ltd.: collaborator

Study Sites (1)

Contact Rayner Intraocular Lenses Limited for Locations

Hove, East Sussex, BN3 7AN, United Kingdom

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Mark Packer, MD

  Consultant

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 4, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2017
• Last Updated: November 22, 2023

Record last verified: 2015-11

Locations

GB (1)