Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT03861351
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2019-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-comparative Trial Following Participants Implanted Bilaterally With Mini WELL Toric Ready Intraocular Lens for 6 Months After the Second Eye Implant (FUSION)
Sponsor:
SIFI SpA
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUSION
Brief 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.
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.
Detailed Description:
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 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.
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 45participants in 3 countries in order to achieve a target number of 38 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.
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 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.
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 45participants in 3 countries in order to achieve a target number of 38 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: