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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02378636
• Other study ID #: 600C-EU-401
• Secondary ID: CFLX-2501
• Status: Withdrawn
• Phase: N/A
• Start date: June 2015
• Est. completion date: August 2017

Study information

• Verified date: November 2015
• Source: Rayner Intraocular Lenses Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• 600S
Monofocal Aspheric Intraocular Lens (IOL)

Locations

Country	Name	City	State
United Kingdom	Contact Rayner Intraocular Lenses Limited for Locations	Hove	East Sussex

Sponsors (2)

Lead Sponsor	Collaborator
Rayner Intraocular Lenses Limited	Visioncare Research Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Distance Visual Acuity (BCDVA)	Best Corrected Distance Visual Acuity	180 Day
Primary	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