Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens

Launched by LENSGEN, INC. · May 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new type of eye lens called the Juvene® intraocular lens (IOL) to see how safe and effective it is for people who have had cataract surgery. Cataracts make the natural lens of the eye cloudy, and after surgery, some patients may experience vision problems due to a condition called presbyopia, which makes it hard to see things up close. The goal of the trial is to find out if this new lens can help improve vision for those who have had their natural lens removed.

To participate in the trial, individuals must be at least 22 years old and able to understand and sign a consent form. They should also be willing to attend follow-up visits for check-ups. However, some people may not be eligible, like those with certain eye conditions or who have had previous eye surgeries. If you join the trial, you can expect to have your vision monitored and receive care from eye specialists throughout the study. The trial is not yet recruiting participants, but it aims to help improve treatment options for cataract patients in the future.

Gender

ALL

Eligibility 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 exclusion criteria specified in the protocol may apply.