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Evaluation of Safety and Performance of the EyenableTM Intraocular Lens for Cataract Treatment

NCT06223113 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-02-01

No results posted yet for this study

Summary

Cataract is characterized by the loss of the normal transparency of the crystalline lens. It is a progressive, chronic disease that affect individuals over the age of 50. It is the leading cause of blindness around the world. The EyenableTM IOL (PA60AS1) is a CE-marked foldable single-piece ultra-violet absorbing posterior chamber intraocular lens (IOL). It is an optical implant to replace the human crystalline lens in the visual correction of aphakia in adult patients after cataract removal. This post-market clinical study will investigate the implantation safety and performance of the EyenableTM PA60AS1 intraocular lens (IOL) up to 6 month after the surgery.

Conditions

  • Cataract

Interventions

DEVICE

EyenableTM PA60AS1 IOL

Subjects will undergo surgery to remove cataract (the cloudy lenses) via phacoemulsification, and implant the Eyedeal® EyenableTM PA60AS1 IOL in the eye capsule.

Sponsors & Collaborators

  • Xi'an Eyedeal Medical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2025-02-28
Completion
2025-02-28

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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 NCT06223113 on ClinicalTrials.gov