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A Clinical Evaluation of the LensGen Intraocular Lens (Grail)

Primary Purpose

Cataract, Presbyopia

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Juvene IOL
Sponsored by
LensGen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centro Oftamologico de Tijuana
  • Dr. Enrique Barragan Oftalmologico

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Juvene IOL

Arm Description

Eyes that have been implanted with the LensGen Juvene IOL

Outcomes

Primary Outcome Measures

Primary Effectiveness Endpoint
Median, monocular, distance-corrected photopic intermediate visual acuity at 66cm is at least 0.2 logMar (20/32)

Secondary Outcome Measures

Full Information

First Posted
May 3, 2022
Last Updated
March 7, 2023
Sponsor
LensGen, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05364658
Brief Title
A Clinical Evaluation of the LensGen Intraocular Lens
Acronym
Grail
Official Title
A Clinical Evaluation of the Safety and Efficacy of the LensGen Intraocular Lens
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 18, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LensGen, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multi-center, open-label, non-comparative clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Juvene IOL
Arm Type
Experimental
Arm Description
Eyes that have been implanted with the LensGen Juvene IOL
Intervention Type
Device
Intervention Name(s)
Juvene IOL
Intervention Description
Indicated for Implantation in the human eye after removal of a cataractous crystalline lens
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint
Description
Median, monocular, distance-corrected photopic intermediate visual acuity at 66cm is at least 0.2 logMar (20/32)
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick R Casey, O.D.
Organizational Affiliation
LensGen, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Centro Oftamologico de Tijuana
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22010
Country
Mexico
Facility Name
Dr. Enrique Barragan Oftalmologico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64060
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35297798
Citation
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.
Results Reference
result

Learn more about this trial

A Clinical Evaluation of the LensGen Intraocular Lens

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