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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.

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.

Condition or disease Intervention/treatment Phase
Cataract Presbyopia Device: Juvene IOL Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
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
Official Title: A Clinical Evaluation of the Safety and Efficacy of the LensGen Intraocular Lens
Actual Study Start Date : November 18, 2018
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
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 :
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05364658


Locations
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Mexico
Centro Oftamologico de Tijuana
Tijuana, Baja California, Mexico, 22010
Dr. Enrique Barragan Oftalmologico
Monterrey, Nuevo Leon, Mexico, 64060
Sponsors and Collaborators
LensGen, Inc.
Investigators
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Study Director: Patrick R Casey, O.D. LensGen, Inc.
Publications of Results:
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Responsible Party: LensGen, Inc.
ClinicalTrials.gov Identifier: NCT05364658    
Other Study ID Numbers: LG-IOL-009
First Posted: May 6, 2022    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors