CompletedNot Applicable

Non-comparative Trial Following Participants Implanted Bilaterally With Mini WELL Toric Ready Intraocular Lens for 6 Months After the Second Eye Implant (FUSION)

France, Germany, Spain58 participantsStarted 2019-09-19

Plain-language summary

This is a multicenter, non-comparative trial following participants implanted bilaterally with the Mini WELL Toric Ready intraocular lens (IOL) for 6 months after the second eye implant. The objective of the study is to evaluate the clinical performance of the Mini WELL Toric Ready intraocular lens (IOL), in particular, visual performance and rotational stability at 6 months following the second eye implantation in participants suffering from bilateral cataract with corneal astigmatism. There are 2 hypotheses: * Rotational Stability: the rotation of the Mini WELL Toric Ready IOL compared between Visit 0a (the day of surgery) and Visit 4 (120 180 days post-operative follow-up) shall be less than ±10° in 90% of the cases. * Severe Visual Distortions: the rate of severe visual distortions for the Mini WELL Toric Ready IOL reported at 6 months postoperative will be less than 10 percents.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Eighteen years of age or older at the time of surgery and diagnosed with bilateral cataracts; * Planned bilateral cataract removal by phacoemulsification; * Preoperative total corneal astigmatism of 0.89 - 2.91 D, measured by corneal topography in both operative eyes; * IOL power and cylinder requirement calculated by the specific web-based Mini Toric Calculator within the following range: * Cylinder of: 1.50 D to 4.00 D * Spherical Equivalent of: 18.00 to 28.00 D * Willing and able to complete all required postoperative visits; * Clear intraocular media other than cataract; * Available for second-eye surgery within 2 weeks of the initial operation; * Potential postoperative visual acuity of 0.3 logMAR in both eyes; * Able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects. Exclusion Criteria: * Irregular / asymmetric astigmatism; * Significant irregular corneal aberration as demonstrated by corneal topography; * Keratopathy / Kerectasia - any corneal abnormality, other than regular corneal astigmatism, including, but not limited to the following: keratoconus, keratoglobus, keratolysis, keratomalacia, keratomicosis and corneal plana; * Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjuntivitis and keratouveitis; * Subjects with diagnosed degenerative visual disorder (e.g. macular degeneration or other retinal disorder…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intraocular lens (IOL) rotation

Timeframe: 6 months after second eye implant

Rate of severe visual distortions

Timeframe: 6 months after second eye implant

Trial details

NCT IDNCT03861351

SponsorSIFI SpA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-11-30

View on ClinicalTrials.gov More Bilateral Cataract trials