A Clinical Evaluation of the LensGen Intraocular Lens

NCT05364658 | Completed

• 1 other identifier: LG-IOL-009
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

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.

Conditions

Cataract; Presbyopia

Outcome Measures

Primary Outcomes (1)

• Primary Effectiveness Endpoint

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

  12 Months

Study Arms (1)

Juvene IOL

EXPERIMENTAL

Eyes that have been implanted with the LensGen Juvene IOL

Device: Juvene IOL

Interventions

Juvene IOL DEVICE

Indicated for Implantation in the human eye after removal of a cataractous crystalline lens

Juvene IOL

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LensGen, Inc.: lead

Study Sites (2)

Centro Oftamologico de Tijuana

Tijuana, Estado de Baja California, 22010, Mexico

Location

Dr. Enrique Barragan Oftalmologico

Monterrey, Nuevo León, 64060, Mexico

Location

Related Publications (1)

• 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.

  PMID: 35297798 RESULT

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Patrick R Casey, O.D.

  LensGen, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, open-label, non-comparative clinical trial

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 6, 2022
• Study Start: November 18, 2018
• Primary Completion: November 30, 2019
• Study Completion: January 30, 2020
• Last Updated: March 9, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)