CataractNirvanaNCT05364983
Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens
A study testing Juvene IOL and Tecnis® Monofocal (ZCB00, PCB00 or DCB00) in people with Cataract and Presbyopia, run by LensGen, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Presbyopia
- What is being tested?
- Juvene IOL and Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Cataract, Presbyopia
- Being tested
- Juvene IOL, Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juvene IOLDevice
Cataract extraction and implantation of a posterior chamber IOL
Tecnis® Monofocal (ZCB00, PCB00 or DCB00)Device
Cataract extraction and implantation of a posterior chamber IOL
| Study group | Role | What they receive |
|---|---|---|
| Investigational IOL | Experimental | Juvene® IOL Receives: Device: Juvene IOL |
| Control IOL | Active comparator | Tecnis® Monofocal (ZCB00, PCB00 or DCB00) Receives: Device: Tecnis® Monofocal (ZCB00, PCB00 or DCB00) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance-corrected intermediate ETDRS LogMar visual acuity
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm
Measured: 12 Months
Distance-corrected intermediate ETDRS LogMar visual acuity vs Control
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) statistical superiority over the Control group
Measured: 12 Months
Defocus curve testing with ETDRS chart
Monocular diopters of depth of focus (DOF)
Measured: 12 Months
Best corrected distance ETDRS LogMar visual acuity vs control
Monocular photopic best corrected distance visual acuity (BCDVA) statistical non-inferiority to the Control group
Measured: 12 Months
Best corrected distance ETDRS LogMar visual acuity
Monocular photopic best corrected distance visual acuity (BCDVA)
Measured: 12 Months
Secondary outcomes (2)
Distance-corrected near ETDRS LogMar visual acuity
Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm
Measured: 12 Months
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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study startMay 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- A prospective, randomized, controlled, double-masked, phased, multicenter clinical study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LensGen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick R Casey, O.D., Study director, LensGen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364983
- Sponsor's protocol ID
- CP20-001
- Acronym
- Nirvana
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 35297798
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05364983
- Acronym / sponsor ID
- Nirvana / CP20-001
- Conditions
- Cataract, Presbyopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- LensGen, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A prospective, randomized, controlled, double-masked, phased, multicenter clinical study
| Arm | Type | Receives |
|---|---|---|
| Investigational IOL | Experimental | Device: Juvene IOLJuvene® IOL |
| Control IOL | Active comparator | Device: Tecnis® Monofocal (ZCB00, PCB00 or DCB00)Tecnis® Monofocal (ZCB00, PCB00 or DCB00) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Juvene IOLCataract extraction and implantation of a posterior chamber IOL | Device | Investigational IOL |
| Tecnis® Monofocal (ZCB00, PCB00 or DCB00)Cataract extraction and implantation of a posterior chamber IOL | Device | Control IOL |
Primary outcome
Distance-corrected intermediate ETDRS LogMar visual acuity
Time frame: 12 Months
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm
Distance-corrected intermediate ETDRS LogMar visual acuity vs Control
Time frame: 12 Months
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) statistical superiority over the Control group
Defocus curve testing with ETDRS chart
Time frame: 12 Months
Monocular diopters of depth of focus (DOF)
Best corrected distance ETDRS LogMar visual acuity vs control
Time frame: 12 Months
Monocular photopic best corrected distance visual acuity (BCDVA) statistical non-inferiority to the Control group
Best corrected distance ETDRS LogMar visual acuity
Time frame: 12 Months
Monocular photopic best corrected distance visual acuity (BCDVA)
2 secondary outcomes
Distance-corrected near ETDRS LogMar visual acuity
Time frame: 12 Months
Distance-corrected near ETDRS LogMar visual acuity vs control
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Background: PubMed 35297798Garg 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.
- Company websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick R Casey, O.D. study director
LensGen, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Juvene IOL and Tecnis® Monofocal (ZCB00, PCB00 or DCB00) in people with Cataract and Presbyopia, run by LensGen, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick R Casey, O.D. ((949) 472-5112, info@lensgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance-corrected intermediate ETDRS LogMar visual acuity (time frame: 12 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05364983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.