Status:
NOT_YET_RECRUITING
Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens
Lead Sponsor:
LensGen, Inc.
Conditions:
Cataract
Presbyopia
Eligibility:
All Genders
22+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Key
- 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
- 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 exclusion criteria specified in the protocol may apply.
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05364983
Start Date
May 1 2023
End Date
November 1 2026
Last Update
March 9 2023
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