Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens
NCT ID: NCT05364983
Last Updated: 2023-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
56 participants
INTERVENTIONAL
2023-05-31
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Investigational IOL
Juvene® IOL
Juvene IOL
Cataract extraction and implantation of a posterior chamber IOL
Control IOL
Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
Cataract extraction and implantation of a posterior chamber IOL
Interventions
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Juvene IOL
Cataract extraction and implantation of a posterior chamber IOL
Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
Cataract extraction and implantation of a posterior chamber IOL
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.)
22 Years
ALL
Yes
Sponsors
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LensGen, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick R Casey, O.D.
Role: STUDY_DIRECTOR
LensGen, Inc.
Central Contacts
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References
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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.
Related Links
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Company website
Other Identifiers
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CP20-001
Identifier Type: -
Identifier Source: org_study_id
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