COMPLETED

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

Conditions

Cataract Senile Cataract Cataract Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Multi-center, Prospective, Randomized, Controlled Clinical Trial to Demonstrate the Safety and Effectiveness of the Full Visual Range AT ELANA 841P Posterior Chamber Intraocular Lens for Correction of Aphakia Following Cataract Removal

Quick Facts

Study Start:2024-07-12

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06264232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Principal Investigator

Seth M Pantanelli, MD

PRINCIPAL_INVESTIGATOR

Penn State Health

Study Locations (Sites)

Beverly Hills Institute of Ophthalmology

Beverly Hills, California, 90210

United States

Mitchell C Shultz MD/Shultz Chang Vision

Northridge, California, 91325

United States

Coastal Vision Medical Group

Orange, California, 92868

United States

Cape Coral Eye Center

Cape Coral, Florida, 33904

United States

Chu Vision Institute

Bloomington, Minnesota, 55420

United States

Ophthalmology Consultants of St Louis

St Louis, Missouri, 63131

United States

Vance Thompson Vision-Nebraska

Omaha, Nebraska, 68137

United States

Cleveland Eye Clinic

Brecksville, Ohio, 44141

United States

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, 29464

United States

Vance Thompson Vision-South Dakota

Sioux Falls, South Dakota, 57108

United States

Whitsett Vision Group

Houston, Texas, 77055

United States

Texas Eye & Laser

Hurst, Texas, 76054

United States

PNV Clinical Research

San Antonio, Texas, 78229

United States

Eye Centers of Racine & Kenosha

Kenosha, Wisconsin, 53142

United States

Collaborators and Investigators

Sponsor: Carl Zeiss Meditec, Inc.

Seth M Pantanelli, MD, PRINCIPAL_INVESTIGATOR, Penn State Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-12

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-07-12

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

Cataract
Cataract Surgery

Additional Relevant MeSH Terms

Cataract Senile