Cataract, Presbyopia
Conditions
Brief summary
To assess the safety and effectiveness of the Juvene® IOL for the treatment of aphakia and mitigation of the effects of presbyopia after removal of the natural crystalline lens due to cataract.
Interventions
DEVICEJuvene IOL
Cataract extraction and implantation of a posterior chamber IOL
DEVICETecnis® Monofocal (ZCB00, PCB00 or DCB00)
Cataract extraction and implantation of a posterior chamber IOL
Sponsors
LensGen, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The subject will be masked to randomization assignment and will be unmasked at the completion of the study. Scheduled masked postoperative assessments will be performed by a masked examiner
Intervention model description
A prospective, randomized, controlled, double-masked, phased, multicenter clinical study
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Subjects must be 22 years of age or older * Able to comprehend and provide written informed consent * Willing and able to comply with schedule for follow-up visits * Demonstrate sufficient cognitive awareness to comply with examination procedures * Other inclusion criteria specified in the protocol may apply. Key
Exclusion criteria
* Subjects with clinically significant dry eye syndrome (DES) expected to impact postoperative visual acuity * Subjects taking medications that may affect ocular function (including but not limited to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents) * Prior intraocular or corneal surgery (including corneal refractive correction i.e., LASIK, PRK, etc.) * Any corneal dystrophy that may affect visual acuity (e.g., keratoconus, pellucid corneal degeneration, etc.) * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance-corrected intermediate ETDRS LogMar visual acuity vs Control | 12 Months | Monocular photopic distance-corrected intermediate visual acuity (DCIVA) statistical superiority over the Control group |
| Best corrected distance ETDRS LogMar visual acuity vs control | 12 Months | Monocular photopic best corrected distance visual acuity (BCDVA) statistical non-inferiority to the Control group |
| Best corrected distance ETDRS LogMar visual acuity | 12 Months | Monocular photopic best corrected distance visual acuity (BCDVA) |
| Distance-corrected intermediate ETDRS LogMar visual acuity | 12 Months | Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm |
| Defocus curve testing with ETDRS chart | 12 Months | Monocular diopters of depth of focus (DOF) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distance-corrected near ETDRS LogMar visual acuity vs control | 12 Months | Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm statistical superiority over the Control group |
| Distance-corrected near ETDRS LogMar visual acuity | 12 Months | Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm |
Contacts
Primary ContactPatrick R Casey, O.D.
Outcome results
None listed