A Clinical Evaluation of the Safety and Efficacy of the LensGen Intraocular Lens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- LensGen, Inc.
- Enrollment
- 61
- Locations
- 2
- Primary Endpoint
- Primary Effectiveness Endpoint
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A multi-center, open-label, non-comparative clinical trial to assess the safety and efficacy of the LensGen IOL (Juvene IOL) for the treatment of aphakia and presbyopia after removal of the natural crystalline lens due to cataract.
Detailed Description
The Juvene IOL is specifically designed to utilize the mechanics of two optics to change the focal point in the human eye to correct presbyopia without the side effects experienced with other presbyopia correcting lenses. One optic provides the base power of the lens. The other contains a central fluid reservoir that utilizes the natural contraction of the ciliary body to change the focal point of the eye via the neural-uveal response induced by looking at an intermediate or near target. The optic material is well characterized and has been safely used as an IOL material. Diffractive and refractive multifocal IOLs provide functional distance and near vision, with up to 4 diopters of add, yet they have not overcome the known side effects of haloes, glare, and reduced contrast sensitivity. Newer presbyopia correcting lenses, such as the Juvene IOL, use novel and proprietary changes in lens curvature to bilaterally change the focal point in each eye to any given distance the patient is looking.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults age 50 to 80 years
- •In good general health at screening as determined by investigator
- •Signed informed consent
- •Cataract for which phacoemulsification extraction and posterior chamber IOL implantation has been planned
- •Capsular bag size measured by UBM and determined to be a good fit for the Juvene IOL
- •Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 either with or without a glare source present (e.g., Brightness Acuity Tester), or scheduled for cataract removal due to significant cataract-related symptoms/complaints
- •Calculated IOL power is within the range of the investigational IOL
- •Preoperative "against the rule" corneal astigmatism (steep@180°) of 1.50 D or less or preoperative "with the rule" corneal astigmatism (steep @90°) of 0.75 D or less.
- •Clear intraocular media other than cataract
- •Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria
- •Uncontrolled systemic or ocular disease incuding clinically diagnosed significant dry eye syndrome (DES)
- •Subjects taking medications that may affect ocular function (including but not limited t to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents,)
- •Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the investigator (tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome))
- •History of ocular trauma or prior ocular surgery
- •Amblyopia or strabismus
- •Any pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, glaucomatous optic neuropathy etc.)
- •Keratoconus, pellucid corneal degeneration or other corneal dystrophy
- •Irregular astigmatism
- •Nystagmus
- •Subjects who may be expected to require retinal laser treatment or other surgical intervention
Outcomes
Primary Outcomes
Primary Effectiveness Endpoint
Time Frame: 12 Months
Median, monocular, distance-corrected photopic intermediate visual acuity at 66cm is at least 0.2 logMar (20/32)