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

Launched by CARL ZEISS MEDITEC, INC. · Feb 12, 2024

Keywords

ClinConnect Summary

The AT ELANA 841P clinical trial is studying a new type of lens called the AT ELANA 841P that is used during cataract surgery to help patients see better after their cataracts are removed. This trial aims to determine how safe and effective this lens is compared to another lens design, the CT LUCIA 621P. Eligible participants are adults aged 22 and older who have significant cataract-related vision problems, specifically those who may not see better than 20/40 vision even with correction. Participants will have surgery on both eyes and will be monitored for up to six months after the procedure, including regular eye exams and surveys about their vision quality.

If you decide to join this trial, you will be randomly assigned to receive one of the two lens types. It's important to note that certain health conditions and previous eye surgeries may disqualify individuals from participating. This trial is currently looking for volunteers, so if you are interested and meet the eligibility criteria, you may have the opportunity to contribute to research that could improve cataract surgery outcomes for many people.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults, 22 years of age or older at the time of study enrollment
• • 2. 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
• • 3. Best corrected distance visual acuity projected to be better than 0.20 logMAR (better than 20/30) after cataract removal and IOL implantation
• • 4. Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D) in both operative eyes
• • 5. Clear intraocular media other than cataract
• • 6. 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.
• • 7. Calculated lens power within the available range
• • 8. Subject is willing to sign the IRB-approved informed consent form
• • 9. Subject is willing, able and has sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits
• Exclusion Criteria:
• • 1. 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.
• • 2. 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)
• • 3. 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
• • 4. 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.
• • 5. 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.)
• • 6. Currently taking systemic steroids and/or planned on taking systemic steroids prior to operative visit and during the course of the investigation.
• • 7. 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.
• • 8. 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
• • 9. 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.)
• • 10. Subjects who are expected to require retinal laser treatment within the next 12 months
• • 11. History of amblyopia or monofixation syndrome with poor stereoscopic vision
• • 12. Rubella, congenital, traumatic or complicated cataracts
• • 13. History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis
• • 14. Microphthalmos or macrophthalmos
• • 15. Iris defects (e.g., aniridia)
• • 16. Optic nerve atrophy
• • 17. Keratoconus or Irregular astigmatism, as determined by topography
• • 18. Inability to perform keratometry, topography or biometry (including but not limited to cataract density, subject unable to focus for longer time etc.) or subjects with unstable keratometry, topography or biometry measurements
• • 19. Pathologic miosis caused by anterior segment pathology in the study eye (e.g., chronic uveitis, iritis, rubeosis iridis, neurological conditions such as multiple sclerosis, Argyle Robertson's pupil, acquired or congenital Horner´s syndrome, etc.)
• • 20. Pupil diameter less than 6 mm when fully dilated
• • 21. Pregnant, lactating at time of enrollment, or has another condition with associated fluctuation of hormones that could lead to refractive changes
• • 22. Subject whose freedom is impaired by administrative or legal order
• • 23. Concurrent participation in another drug or device investigation that could confound the outcome of this investigation
• • 24. Subjects unable to achieve keratometry stability after discontinuing contact lens wear
• • 25. Gonioscopic abnormalities