Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens (Nirvana)
Primary Purpose
Cataract, Presbyopia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Juvene IOL
Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Key Inclusion Criteria:
- Subjects must be 22 years of age or older
- Able to comprehend and provide written informed consent
- Willing and able to comply with schedule for follow-up visits
- Demonstrate sufficient cognitive awareness to comply with examination procedures
- Other inclusion criteria specified in the protocol may apply.
Key Exclusion Criteria:
- Subjects with clinically significant dry eye syndrome (DES) expected to impact postoperative visual acuity
- Subjects taking medications that may affect ocular function (including but not limited to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents)
- Prior intraocular or corneal surgery (including corneal refractive correction i.e., LASIK, PRK, etc.)
- Any corneal dystrophy that may affect visual acuity (e.g., keratoconus, pellucid corneal degeneration, etc.)
- Other exclusion criteria specified in the protocol may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Investigational IOL
Control IOL
Arm Description
Juvene® IOL
Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
Outcomes
Primary Outcome Measures
Distance-corrected intermediate ETDRS LogMar visual acuity
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm
Distance-corrected intermediate ETDRS LogMar visual acuity vs Control
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) statistical superiority over the Control group
Defocus curve testing with ETDRS chart
Monocular diopters of depth of focus (DOF)
Best corrected distance ETDRS LogMar visual acuity vs control
Monocular photopic best corrected distance visual acuity (BCDVA) statistical non-inferiority to the Control group
Best corrected distance ETDRS LogMar visual acuity
Monocular photopic best corrected distance visual acuity (BCDVA)
Secondary Outcome Measures
Distance-corrected near ETDRS LogMar visual acuity
Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm
Distance-corrected near ETDRS LogMar visual acuity vs control
Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm statistical superiority over the Control group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05364983
Brief Title
Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens
Acronym
Nirvana
Official Title
A Prospective, Randomized, Controlled, Double-Masked, Phased, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of the LensGen® Juvene® Intraocular Lens
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2026 (Anticipated)
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
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the safety and effectiveness of the Juvene® IOL for the treatment of aphakia and mitigation of the effects of presbyopia after removal of the natural crystalline lens due to cataract.
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
A prospective, randomized, controlled, double-masked, phased, multicenter clinical study
Masking
ParticipantCare Provider
Masking Description
The subject will be masked to randomization assignment and will be unmasked at the completion of the study. Scheduled masked postoperative assessments will be performed by a masked examiner
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigational IOL
Arm Type
Experimental
Arm Description
Juvene® IOL
Arm Title
Control IOL
Arm Type
Active Comparator
Arm Description
Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
Intervention Type
Device
Intervention Name(s)
Juvene IOL
Intervention Description
Cataract extraction and implantation of a posterior chamber IOL
Intervention Type
Device
Intervention Name(s)
Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
Intervention Description
Cataract extraction and implantation of a posterior chamber IOL
Primary Outcome Measure Information:
Title
Distance-corrected intermediate ETDRS LogMar visual acuity
Description
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm
Time Frame
12 Months
Title
Distance-corrected intermediate ETDRS LogMar visual acuity vs Control
Description
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) statistical superiority over the Control group
Time Frame
12 Months
Title
Defocus curve testing with ETDRS chart
Description
Monocular diopters of depth of focus (DOF)
Time Frame
12 Months
Title
Best corrected distance ETDRS LogMar visual acuity vs control
Description
Monocular photopic best corrected distance visual acuity (BCDVA) statistical non-inferiority to the Control group
Time Frame
12 Months
Title
Best corrected distance ETDRS LogMar visual acuity
Description
Monocular photopic best corrected distance visual acuity (BCDVA)
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Distance-corrected near ETDRS LogMar visual acuity
Description
Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm
Time Frame
12 Months
Title
Distance-corrected near ETDRS LogMar visual acuity vs control
Description
Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm statistical superiority over the Control group
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
Subjects must be 22 years of age or older
Able to comprehend and provide written informed consent
Willing and able to comply with schedule for follow-up visits
Demonstrate sufficient cognitive awareness to comply with examination procedures
Other inclusion criteria specified in the protocol may apply.
Key Exclusion Criteria:
Subjects with clinically significant dry eye syndrome (DES) expected to impact postoperative visual acuity
Subjects taking medications that may affect ocular function (including but not limited to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents)
Prior intraocular or corneal surgery (including corneal refractive correction i.e., LASIK, PRK, etc.)
Any corneal dystrophy that may affect visual acuity (e.g., keratoconus, pellucid corneal degeneration, etc.)
Other exclusion criteria specified in the protocol may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick R Casey, O.D.
Phone
(949) 472-5112
Email
info@lensgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick R Casey, O.D.
Organizational Affiliation
LensGen, Inc.
Official's Role
Study Director
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
background
Links:
URL
http://lensgen.com
Description
Company website
Learn more about this trial
Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens
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