Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal Intraocular Lenses (IOL)

Alcon

Status: Completed

Conditions: Cataracts

Treatments: Device: AT LISA® tri IOL; Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02691741

ILH297-P003

Details and patient eligibility

About

The purpose of this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting Trifocal IOLs.

Full description

Subjects will attend a total of 9 visits (6 postoperative) over a 7 month period.

Enrollment: 215 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of bilateral cataracts with planned clear cornea cataract removal;
• Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
• Calculated lens power between 13.0 and 30.0 Diopters (D);
• Preoperative Best-corrected distance visual acuity (BCDVA) worse than 0.20 logMAR (ie, 0.22 logMAR or worse) in at least one eye;
• Potential postoperative BCDVA of 0.20 logMAR or better in both eyes. Note: Subjects with any pathology that could reduce visual potential should not be enrolled in this trial;
• Preoperative regular corneal astigmatism of < 1.00 D, in both eyes;
• Clear intraocular media other than cataract in both eyes;
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Reasonably expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy);
• Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions);
• Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
• Amblyopia;
• Previous corneal transplant;
• Any recurrent severe anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction;
• Rubella, congenital, traumatic, or complicated cataracts;
• Glaucoma (uncontrolled or controlled with medication);
• Degenerative eye disorders;
• History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy;
• Optic nerve atrophy;
• Expected to require retinal laser treatment;
• Color vision deficiencies;
• Pregnant or lactating (current or planned during the course of the study);
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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215 participants in 2 patient groups

TFNT00

Experimental group

Description:

AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation

Treatment:

Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

839MP

Active Comparator group

Description:

AT LISA® tri IOL, bilateral implantation

Treatment:

Device: AT LISA® tri IOL