Trials / Unknown
UnknownNCT06223113
Evaluation of Safety and Performance of the EyenableTM Intraocular Lens for Cataract Treatment
Prospective, Registry-based Study to Evaluate Safety and Performance of EyenableTM Intraocular Lens Implantation After Cataract Removal
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Xi'an Eyedeal Medical Technology Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-02-01
- Primary completion
- 2025-02-01
- Completion
- 2025-02-01
- First posted
- 2024-01-25
- Last updated
- 2024-02-01
Source: ClinicalTrials.gov record NCT06223113. Inclusion in this directory is not an endorsement.