Clinical Trials Logo
  1. Home
  2. Astigmatism
  3. NCT03861351

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

Astigmatism Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03861351
Study type Interventional
Source SIFI SpA
Contact
Status Completed
Phase N/A
Start date September 19, 2019
Completion date November 30, 2021
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04778501 - PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia N/A
Completed NCT04536571 - Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses N/A
Completed NCT05039112 - Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses N/A
Completed NCT04613882 - Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses N/A
Recruiting NCT05611294 - Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction N/A
Completed NCT05633082 - A Clinical Performance of Two Soft Toric Contact Lenses N/A
Not yet recruiting NCT05561296 - Astigmatism Management With Iris-registration Guided Corneal Relaxing Incisions or Toric IOLs During Cataract Surgery N/A
Not yet recruiting NCT05506553 - Comparison of Aspheric Toric Intraocular Lenses for Micro-monovision N/A
Completed NCT02847169 - Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear N/A
Recruiting NCT02618018 - Clinical Evaluation of Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery N/A
Completed NCT02555098 - A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens N/A
Completed NCT02551796 - Early Changes Among FLEx, LASIK and FS-LASIK N/A
Completed NCT02550353 - Changes Between Lenticule Extraction and Femtosecond Laser-assisted Laser in Situ Keratomileusis N/A
Completed NCT02423109 - Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses N/A
Completed NCT02248766 - Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric Lenses N/A
Completed NCT01965288 - Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism N/A
Completed NCT01857102 - Toric Eye Strain and Stability Study N/A
Completed NCT02624791 - Evaluating and Improving Functional Driving Vision of Patients With Astigmatism N/A
Withdrawn NCT01680354 - Surgical Correction of Astigmatism N/A
Completed NCT01207466 - Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism N/A