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

This is an interventional treatment trial for Bilateral Cataract focused on measuring Cataract, Astigmatism Read More

Inclusion Criteria:

• 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 Criteria:

• 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.