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

NCT03861351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-04-18

No results posted yet for this study

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.

Conditions

  • Bilateral Cataract
  • Astigmatism

Interventions

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.

Sponsors & Collaborators

  • SIFI SpA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-19
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • France
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03861351 on ClinicalTrials.gov