Cataract
Conditions
Brief summary
This is a clinical trial comparing an investigative accommodative IOL and two commercial IOLs in patients with cataracts undergoing primary cataract surgery.
Detailed description
This is a prospective, multicenter clinical study comparing the safety and performance of the Opira accommodative IOL, a commercial monofocal IOL, and a commercial multifocal IOL. Eligible patients with bilateral cataracts will undergo cataract surgery implanting one of three study lenses, and will be followed postoperatively for 24 months
Interventions
DEVICECataract Surgery
The surgical procedure in which the natural crystalline lens is removed and replaced with a lens implant.
Sponsors
FSV6, Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects aged 50-75 with bilateral cataracts, good potential vision, and clear intraocular media other than lens opacity
Exclusion criteria
* Comorbidities affecting visual acuity, IOP \> 22mmHg, congential cataract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Acuity | 6 Months |
| Adverse event rates | 12 Months |
Countries
Costa Rica, Mexico
Contacts
Primary ContactPaul Rhee, O.D
Outcome results
None listed