Non-comparative Trial Following Participants Implanted Bilaterally With Mini WELL Toric Ready Intraocular Lens for 6 Months After the Second Eye Implant (FUSION) (FUSION)
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|ClinicalTrials.gov Identifier: NCT03861351|
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : January 18, 2020
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 percents of the cases, less than ±20° in 95 percents of the cases, and less than ±30° in 99 percents 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.
|Condition or disease||Intervention/treatment||Phase|
|Bilateral Cataract Astigmatism||Device: Mini WELL Toric Ready intraocular lens||Not Applicable|
This is an interventional, multicenter, non-comparative post-marketing clinical investigation in participants implanted bilaterally with the Mini WELL Toric Ready intraocular lens (IOL) for 6 months after the second eye implant.
The objective of this study is to evaluate the clinical performance of the Mini WELL Toric Ready IOL, in particular, visual performance and rotational stability at 6 months following second eye implantation.
The first hypothesis raised for this study is related to rotational stability. The rotation of the Mini WELL Toric Ready IOL between Visit 0a (the day of the surgery) and Visit 4 (120-180 day post-operative follow-up) shall be less than 10° in 90 percents of the cases, less than 20° in 95 percents of the cases, and less than 30° in 99 percents of the cases.
The second hypothesis is regarding severe visual distortions. The rate of severe visual distortions for the Mini WELL Toric Ready IOL reported 6 months post-operative will be less than 10 percents.
The study will involve 69 participants in 3 countries in order to achieve a target number of 60 evaluable participants completing the study.
This clinical study is composed of 9 scheduled visits. Following completion of the Informed Consent process, a pre-operative examination will take place to determine each patient's eligibility. Eligible patients, who wish to continue with the study, will be invited to undergo their first surgical procedure within 30 days. They will be required to undergo their second surgical procedure within 2 weeks of the initial operation. They will also be required to return for additional post-operative follow-up visits, 1-2 days after each eye surgery, 7-14 days after each eye surgery, 30-60 days after bilateral surgery and 120-180 days after bilateral surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Men and women aged ≥ 18 years old suffering from bilateral cataract and astigmatism|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Non-controlled and Open-label Trial Following Subjects Implanted Bilaterally With the Toric Extended-depth-of-focus Mini WELL Toric Ready Intraocular Lens for 6 Months After the Second Eye Implant|
|Actual Study Start Date :||September 19, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||September 2020|
|Experimental: Mini WELL Toric Ready intraocular lens||
Device: Mini WELL Toric Ready intraocular lens
The aim of cataract surgery is to remove the cloudy lens and replace it with the artificial intraocular lens called Mini WELL Toric Ready to correct presbyopia and to correct corneal astigmatism.
- Intraocular lens (IOL) rotation [ Time Frame: 6 months after second eye implant ]To evaluate the rotational stability of Mini WELL Toric Ready IOL.
- Rate of severe visual distortions [ Time Frame: 6 months after second eye implant ]To evaluate the visual performance of Mini WELL Toric Ready IOL.
- The rate of visual disturbances as detected with the Halometry test [ Time Frame: 6 months after second eye implant ]
- The rate of secondary surgical interventions (SSIs) related to the optical properties of the IOL for first and second operative eye separately [ Time Frame: 6 months after second eye implant ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861351
|Contact: Gianluca Stivale||+39 0957922335||Gianluca.Stivale@sifigroup.com|
|Service ophtalmologie Segment Antérieur- Hopital Pellegrin - CHU de Bordeaux||Active, not recruiting|
|Bordeaux, France, 33076|
|Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)||Recruiting|
|Heidelberg, Germany, 69120|
|Contact: Gerd Uwe Auffarth, Professor +49 6221 566624 firstname.lastname@example.org|
|Contact: Raquel Willrich Amroussi, Study coordinator +49 6221 566624 Raquel.WillrichAmroussi@med.uni-heidelberg.de|
|OFTALVIST CIO JEREZ Clínica Jerez (Cadiz)||Recruiting|
|Jerez De La Frontera, Spain, 11407|
|Contact: Ramon Ruiz Mesa, Doctor +34 956 357263 email@example.com|
|Contact: Julia Ruiz, Study coordinator +34 956 357263 firstname.lastname@example.org|