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A Clinical Evaluation of the LensGen Intraocular Lens (Grail)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05364658
Recruitment Status : Completed
First Posted : May 6, 2022
Last Update Posted : March 9, 2023
Sponsor:
Information provided by (Responsible Party):
LensGen, Inc.

Tracking Information
First Submitted Date  ICMJE May 3, 2022
First Posted Date  ICMJE May 6, 2022
Last Update Posted Date March 9, 2023
Actual Study Start Date  ICMJE November 18, 2018
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2022)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Evaluation of the LensGen Intraocular Lens
Official Title  ICMJE A Clinical Evaluation of the Safety and Efficacy of the LensGen Intraocular Lens
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Multi-center, open-label, non-comparative clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cataract
  • Presbyopia
Intervention  ICMJE Device: Juvene IOL
Indicated for Implantation in the human eye after removal of a cataractous crystalline lens
Study Arms  ICMJE Experimental: Juvene IOL
Eyes that have been implanted with the LensGen Juvene IOL
Intervention: Device: Juvene IOL
Publications * Garg S, De Jesus MT, Fletcher LM, Chayet A, Barragan E, Casey P. Twelve-month clinical outcomes after implantation of a new, modular, anterior shape-changing fluid optic intraocular lens. J Cataract Refract Surg. 2022 Oct 1;48(10):1134-1140. doi: 10.1097/j.jcrs.0000000000000935.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2022)
61
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 30, 2020
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 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

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
  • Capsule or zonular abnormalities that may affect postoperative lens stability (e.g.

pseudoexfoliation syndrome)

  • 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:

    • Zonular instability
    • Need for iris manipulation
    • Capsular fibrosis or other opacity
    • Inability to fixate IOL in desired position
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05364658
Other Study ID Numbers  ICMJE LG-IOL-009
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party LensGen, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE LensGen, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Patrick R Casey, O.D. LensGen, Inc.
PRS Account LensGen, Inc.
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP