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

Study Overview
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Device: 600S


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 600S<br>Modified 600C (axis marks) monofocal aspheric intraocular lens | Device: 600S<br>* Monofocal Aspheric Intraocular Lens (IOL)<br>* Other names: Modified 600C (axis marks);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |