An interventional study of 600S in Cataract, sponsored by Rayner Intraocular Lenses Limited. Withdrawn at 1 site in United Kingdom. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Rayner Intraocular Lenses Limited · Not applicable, Interventional, and Treatment
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
Browse Cataract studies →Rayner Intraocular Lenses Limited is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Modified 600C (axis marks) monofocal aspheric intraocular lens
Device: 600S
Monofocal Aspheric Intraocular Lens (IOL)
Also known as: Modified 600C (axis marks)
Best Corrected Distance Visual Acuity (BCDVA)
Best Corrected Distance Visual Acuity
Time frame: 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
Time frame: 180 Day
This study is withdrawn, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Rayner Intraocular Lenses Limited