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

NCT06264232 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2025-12-16

No results posted yet for this study

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

Interventions

DEVICE

Cataract Surgery

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

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Carl Zeiss Meditec, Inc.

    lead INDUSTRY

Principal Investigators

  • Seth M Pantanelli, MD · Penn State Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-12
Primary Completion
2025-11-03
Completion
2025-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06264232 on ClinicalTrials.gov