Grail: A Clinical Evaluation of the LensGen Intraocular Lens
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.
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.
Arms and Interventions
|Experimental: Juvene IOL
Eyes that have been implanted with the LensGen Juvene IOL
Device: Juvene IOL
Indicated for Implantation in the human eye after removal of a cataractous crystalline lens
Primary Outcome Measures
- Primary Effectiveness Endpoint [12 Months]
Median, monocular, distance-corrected photopic intermediate visual acuity at 66cm is at least 0.2 logMar (20/32)
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
Potential visual acuity of 20/32 or better in both eyes after cataract removal and IOL implantation as determined by diagnostic testing or investigator's judgement.
No secondary procedures (such as LASIK) will be allowed during the term of the study
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
Subjects who may be expected to require retinal laser treatment or other surgical intervention
Capsule or zonular abnormalities that may affect postoperative lens stability (e.g.
Pupil abnormalities (non-reactive, tonic pupil, abnormally shaped pupil, rubeosis iridis, aniridia, or iris coloboma), or pupils that don't dilate at least 6.0 mm pharmacologically.
Any pre-existing ocular conditions such as pseudoexfoliation, chronic uveitis, corneal dystrophy, traumatic cataract, white cataracts which lead to radicalization of the capsulorhexis
Women who are pregnant or plan on getting pregnant during the term of the study
Concurrent participation in another drug or device investigation
Subjects shall be excluded when certain conditions are present at the time of surgery including:
Need for iris manipulation
Capsular fibrosis or other opacity
Inability to fixate IOL in desired position
Contacts and Locations
|Centro Oftamologico de Tijuana
|Dr. Enrique Barragan Oftalmologico
Sponsors and Collaborators
- LensGen, Inc.
- Study Director: Patrick R Casey, O.D., LensGen, Inc.
Study Documents (Full-Text)None provided.