CompletedNot Applicable

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

United States284 participantsStarted 2024-07-12

Plain-language 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.

Who can participate

Age range22 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

What they're measuring

Primary Effectiveness Outcome

Timeframe: Month 6

Primary Effectiveness Outcome

Timeframe: Month 6

Primary Effectiveness Outcome

Timeframe: Month 6

Primary Effectiveness Outcome

Timeframe: Month 6

Primary Effectiveness Outcome

Timeframe: Month 6

Primary Safety Outcome

Timeframe: Month 6

Primary Safety Outcome

Timeframe: Month 6

Primary Safety Outcome

Timeframe: Month 6

Trial details

NCT IDNCT06264232

SponsorCarl Zeiss Meditec, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-03

View on ClinicalTrials.gov More Cataract Senile trials

Plain-language summary

Who can participate

Age range22 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

What they're measuring

Primary Effectiveness Outcome

Timeframe: Month 6

Primary Effectiveness Outcome

Timeframe: Month 6

Primary Effectiveness Outcome

Timeframe: Month 6

Primary Effectiveness Outcome

Timeframe: Month 6

Primary Effectiveness Outcome

Timeframe: Month 6

Primary Safety Outcome

Timeframe: Month 6

Primary Safety Outcome

Timeframe: Month 6

Primary Safety Outcome

Timeframe: Month 6