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

NCT03861351 | Completed

• 1 other identifier: PSM36
• Study Type: interventional
• Target: 58
• Locations: 3 countries
• Sites: 4

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.

Conditions

Bilateral Cataract; Astigmatism

Keywords

Cataract; Astigmatism

Outcome Measures

Primary Outcomes (2)

• Intraocular lens (IOL) rotation

  To evaluate the rotational stability of Mini WELL Toric Ready IOL.

  6 months after second eye implant

• Rate of severe visual distortions

  To evaluate the visual performance of Mini WELL Toric Ready IOL.

  6 months after second eye implant

Other Outcomes (2)

• The rate of visual disturbances as detected with the Halometry test

  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

  6 months after second eye implant

Study Arms (1)

Mini WELL Toric Ready intraocular lens

EXPERIMENTAL

Device: Mini WELL Toric Ready intraocular lens

Interventions

Mini WELL Toric Ready intraocular lens DEVICE

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.

Mini WELL Toric Ready intraocular lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 0.3 logMAR;
• Subjects who may have reasonably been expected to require a secondary surgical intervention at any time during the study (other than Nd:YAG capsulotomy);
• Subjects in whom the intraocular lens might interfere with the ability to observe, diagnose or treat posterior segment conditions;
• Previous corneal refractive surgery;
• Other planned ocular surgery procedures, including, but not limited to LASIK, astigmatic keratotomy, retinal laser treatment and limbal relaxing incisions, for the duration of the study;
• Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens, including but not limited to the following: pseudo-exfoliation syndrome, chronic uveitis, Marfan's Syndrome;
• Absence of adequate capsular support for the implant of the intraocular lens in the capsular bag;
• Absence of adequate support for the lens from the posterior chamber or the zonule;
• Pupil abnormalities, including but not limited to the following: non-reactive, tonic pupils that do not dilatate under mesopic/scotopic conditions, abnormally shaped pupils or abnormally positioned pupils;
• Amblyopia;
• Clinically severe corneal dystrophy (e.g. epithelial, stromal, or endothelial dystrophy);

Sponsors & Collaborators

• SIFI SpA: lead

Study Sites (4)

Service ophtalmologie Segment Antérieur- Hopital Pellegrin - CHU de Bordeaux

Bordeaux, 33076, France

Location

Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)

Heidelberg, 69120, Germany

Location

OFTALVIST CIO JEREZ Clínica Jerez (Cadiz)

Jerez de la Frontera, 11407, Spain

Location

Hospital Universitario Quirónsalud Madrid

Madrid, 28223, Spain

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Men and women aged ≥ 18 years old suffering from bilateral cataract and astigmatism

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 4, 2019
• Study Start: September 19, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

FR (1); DE (1); ES (2)