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

NCT ID: NCT02378636

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-08-31

Brief Summary

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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

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Conditions

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Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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600S

Modified 600C (axis marks) monofocal aspheric intraocular lens

Group Type EXPERIMENTAL

600S

Intervention Type DEVICE

Monofocal Aspheric Intraocular Lens (IOL)

Interventions

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600S

Monofocal Aspheric Intraocular Lens (IOL)

Intervention Type DEVICE

Other Intervention Names

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Modified 600C (axis marks)

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Visioncare Research Ltd.

OTHER

Sponsor Role collaborator

Rayner Intraocular Lenses Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Packer, MD

Role: STUDY_CHAIR

Consultant

Locations

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Hove, East Sussex, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CFLX-2501

Identifier Type: OTHER

Identifier Source: secondary_id

600C-EU-401

Identifier Type: -

Identifier Source: org_study_id