Status:
COMPLETED
Non-comparative Trial Following Participants Implanted Bilaterally With Mini WELL Toric Ready Intraocular Lens for 6 Months After the Second Eye Implant (FUSION)
Lead Sponsor:
SIFI SpA
Conditions:
Bilateral Cataract
Astigmatism
Eligibility:
All Genders
18+ years
Phase:
NA
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 objectiv...
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 a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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);
- Proliferative diabetic retinopathy;
- Microphthalmos;
- Suspected microbial infection;
- Previous retinal detachment;
- Previous corneal transplant;
- Optic nerve atrophy;
- Extremely shallow anterior chamber, not due to swollen cataract;
- Recurrent severe anterior or posterior segment inflammation of unknown aetiology (e.g. chronic uveitis);
- Iris neovascularization;
- Glaucoma (uncontrolled or controlled with medication);
- Aniridia or iris atrophy;
- Severe dry eye;
- Use of any systemic or topical drug known to interfere with visual performance;
- Subjects with any systemic disease that could increase operative risk or confound the outcomes (e.g. uncontrolled diabetes);
- Use of contact lens within the last 30 days before the preoperative visit;
- Vulnerable subjects (children \<18 years, people in guardianship or trusteeship or inability to give an informed consent);
- Pregnant or lactating or planning a pregnancy at the time of enrolment;
- Subjects with psychiatric disorders that could confound the outcomes;
- Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days.
- Intra-operative exclusion criteria:
- Irregularity and decentration of capsulorhexis;
- Other ocular surgery procedures, including, but not limited to LASIK, astigmatic keratotomy, retinal laser treatment and limbal relaxing incisions, for the duration of the study;
- Significant vitreous loss;
- Significant anterior chamber hyphema;
- Uncontrollable intraocular pressure (IOP);
- Zonular or capsular rupture;
- Ciliary sulcus, Bag-sulcus, sulcus-sulcus or unknown placement of the haptics.
Key Trial Info
Start Date :
September 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03861351
Start Date
September 19 2019
End Date
November 30 2021
Last Update
April 18 2023
Active Locations (4)
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1
Service ophtalmologie Segment Antérieur- Hopital Pellegrin - CHU de Bordeaux
Bordeaux, France, 33076
2
Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC)
Heidelberg, Germany, 69120
3
OFTALVIST CIO JEREZ Clínica Jerez (Cadiz)
Jerez de la Frontera, Spain, 11407
4
Hospital Universitario Quirónsalud Madrid
Madrid, Spain, 28223