AT ELANA 841P Posterior Chamber Intraocular Lens for Correction of Aphakia Following Cataract Removal

NCT06264232 | Completed FDA Device

• 1 other identifier: AT ELANA 841P-BER-303-24
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 14

Brief Summary

The goal of this clinical trial is to demonstrate the safety and effectiveness of the full visual range AT ELANA 841P IOL when used to treat adult patients having cataract surgery. Subjects will be randomly selected to receive a pair of IOLs, either the AT ELANA 841P or CT LUCIA 621P lens design. All patients will undergo surgery in both eyes, and they will receive follow up care for up to 6-months. During this time, all patients will undergo thorough eye exams at every study visit and complete questionnaires about their quality of vision post-surgery.

Conditions

Cataract Senile

Keywords

Cataract; Cataract Surgery

Outcome Measures

Primary Outcomes (8)

• Primary Effectiveness Outcome

  Mean, monocular photopic logMAR best-corrected distance visual acuity (BCDVA) at 4 m for the first implanted eyes, at Month 6 (Visit 4).

  Month 6

• Primary Effectiveness Outcome

  Mean, monocular photopic logMAR distance-corrected near visual acuity (DCNVA) at 40 cm, for the first implanted eyes at Month 6 (Visit 4)

  Month 6

• Primary Effectiveness Outcome

  Mean, monocular photopic logMAR distance-corrected intermediate visual acuity (DCIVA) for the first implanted eyes at 66 cm, at Month 6 (Visit 4)

  Month 6

• Primary Effectiveness Outcome

  Mean, monocular photopic logMAR distance-corrected visual acuity (DCVA) at 1 m (equal to -1 D defocus) and 50 cm (equal to -2 D defocus), for the first implanted eyes at Month 6 (Visit 4)

  Month 6

• Primary Effectiveness Outcome

  Proportion of AT ELANA 841P IOL eyes achieving monocular photopic BCDVA 0.30 logMAR or better, for first implanted eyes in Full Analysis Set (FAS) and Best Case Set (BCS), at Month 6 (Visit 4)

  Month 6

• Primary Safety Outcome

  Mean log monocular mesopic far contrast sensitivity (without glare at spatial frequency of 1,5, 3, 6, and 12 cycles/degree) for first implanted eyes in Best Case Set (BCS), at Month 6 (Visit 4)

  Month 6

• Primary Safety Outcome

  Rate of secondary surgical interventions related to the optical properties of the lens for first implanted eyes, through 6 months.

  Month 6

• Primary Safety Outcome

  Rate of Posterior Chamber IOL cumulative and persistent adverse events (AEs) listed in the ISO 11979-7:2024 Table E.2, for first implanted eyes, through 6 months.

  Month 6

Study Arms (2)

AT ELANA 841P IOL

EXPERIMENTAL

Cataract Surgery to implant multifocal intraocular lenses

Device: Cataract Surgery

CT LUCIA 621P IOL

ACTIVE COMPARATOR

Cataract Surgery to implant monofocal intraocular lenses

Device: Cataract Surgery

Interventions

Cataract Surgery DEVICE

Bilateral removal of age related cataractous lenses with the implantation of intraocular lenses to improve visual acuity.

AT ELANA 841P IOL; CT LUCIA 621P IOL

Eligibility Criteria

• Age: 22 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, 22 years of age or older at the time of study enrollment
• Bilateral cataractous lens changes as demonstrated by best corrected distance visual acuity of 0.30 logMAR (20/40) or worse either with or without a glare source present (e.g., Brightness Acuity Tester) for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated
• Best corrected distance visual acuity projected to be better than 0.20 logMAR (better than 20/30) after cataract removal and IOL implantation
• Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D) in both operative eyes
• Clear intraocular media other than cataract
• Contact lens wear is to be discontinued two (2) weeks for soft contact lenses both daily and extended wear; and ≥ 30 days for rigid gas permeable lenses prior to preoperative biometry and keratometry testing.
• Calculated lens power within the available range
• Subject is willing to sign the IRB-approved informed consent form
• Subject is willing, able and has sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits

You may not qualify if:

• Presence of systemic disease that could increase the operative risk or confound the outcome, including but not limited to diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.
• Ocular condition that may predispose for future complications, including but not limited to dry eye syndromes or symptoms, anterior segment pathology, glaucoma (uncontrolled despite intake of medication), history of cystoid macular edema, macular degeneration as confirmed by clinical examination and adjunct testing (e.g., OCT, FA)
• Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity, inflammation or edema; conditions including but not limited to active/inactive keratitis, keratoconjunctivitis, kerato uveitis, keratopathy, keratectasia
• Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject, including corneal transplants, retinal detachment, glaucoma surgeries, refractive laser procedures including but not limited to LASIK, limbal relaxing incision, Small Incision Lenticule Extraction (SMILE) etc.
• Use of or history of use of systemic medications with significant ocular side effects or any medications that could confound the outcome or increase subject risk (e.g., Tamsulosin Hydrochloride \[Flomax\] or other medications including anticholinergics or alpha-adrenergic blocking agents with similar side effects \[e.g., small pupil/floppy iris syndrome\], antimetabolites, etc.)
• Currently taking systemic steroids and/or planned on taking systemic steroids prior to operative visit and during the course of the investigation.
• Subjects with diagnosed degenerative visual disorders, including but not limited to macular degeneration or other retinal disorders (such as diabetic retinopathy, diabetic macular edema, retinal detachment) that are predicted to confound outcomes or to cause future acuity loss to 0.20 logMAR or worse.
• Subjects with conditions that increase the risk of zonular rupture (e.g., pseudoexfoliation syndrome, Marfan's syndrome) during cataract extraction procedure that may affect the postoperative centration or tilt of the IOL
• Expected concomitant ocular procedure during cataract surgery or within the next 12 months (e.g., glaucoma surgery including implantation of MIGS, astigmatic correction surgery, penetrating keratoplasty \[PK\], laser-assisted in situ keratomileusis, SMILE etc.)
• Subjects who are expected to require retinal laser treatment within the next 12 months
• History of amblyopia or monofixation syndrome with poor stereoscopic vision
• Rubella, congenital, traumatic or complicated cataracts
• History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis
• Microphthalmos or macrophthalmos
• Iris defects (e.g., aniridia)

Sponsors & Collaborators

• Carl Zeiss Meditec, Inc.: lead
• ORA, Inc.: collaborator

Study Sites (14)

Beverly Hills Institute of Ophthalmology

Beverly Hills, California, 90210, United States

Location

Mitchell C Shultz MD/Shultz Chang Vision

Northridge, California, 91325, United States

Location

Coastal Vision Medical Group

Orange, California, 92868, United States

Location

Cape Coral Eye Center

Cape Coral, Florida, 33904, United States

Location

Chu Vision Institute

Bloomington, Minnesota, 55420, United States

Location

Ophthalmology Consultants of St Louis

St Louis, Missouri, 63131, United States

Location

Vance Thompson Vision-Nebraska

Omaha, Nebraska, 68137, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

Vance Thompson Vision-South Dakota

Sioux Falls, South Dakota, 57108, United States

Location

Whitsett Vision Group

Houston, Texas, 77055, United States

Location

Texas Eye & Laser

Hurst, Texas, 76054, United States

Location

PNV Clinical Research

San Antonio, Texas, 78229, United States

Location

Eye Centers of Racine & Kenosha

Kenosha, Wisconsin, 53142, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Seth M Pantanelli, MD

  Penn State Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Masking will include not knowing which type of IOLs were received by the subject until end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 16, 2024
• Study Start: July 12, 2024
• Primary Completion: November 3, 2025
• Study Completion: December 1, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)