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Evaluation of Safety and Performance Outcomes of Eyedeal IOL Implantation After Cataract Removal

NCT05776095 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2024-02-02

No results posted yet for this study

Summary

A cataract is the clouding of the natural lens in the eye and is very common as when getting older. A cloudy lens makes it difficult to see. A cataract is treated by removing the cloudy lens and replacing it with an intraocular lens (known as an IOL). The goal of this clinical trial is to determine if the Eyedeal® IOL can be safely implanted in a subject's eye and if it can replace efficiently the natural lens.

Subjects will be asked to attend a total of seven visits for this study for a period of 12 months after surgery.

Conditions

  • Lens Implantation, Intraocular

Interventions

PROCEDURE

Cataract surgery

Subjects will undergo surgery to remove cataract (the cloudy lenses) via phacoemulsification, and implant the Eyedeal® Model PX65AS1 IOL in the eye capsule.

DEVICE

Eyedeal® Model PX65AS1 IOL

Subjects will undergo surgery to remove cataract (the cloudy lenses) via phacoemulsification, and implant the Eyedeal® Model PX65AS1 IOL in the eye capsule.

Sponsors & Collaborators

  • Xi'an Eyedeal Medical Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Gerd Auffarth, Prof · University Eye Clinic Heidelberg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Germany
  • Lithuania

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 NCT05776095 on ClinicalTrials.gov