Evaluation of Safety and Performance of the EyenableTM Intraocular Lens for Cataract Treatment - Trial NCT06223113
Access comprehensive clinical trial information for NCT06223113 through Pure Global AI's free database. This phase not specified trial is sponsored by Xi'an Eyedeal Medical Technology Co., Ltd and is currently Not yet recruiting. The study focuses on Cataract. Target enrollment is 200 participants.
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Study Focus
Sponsor & Location
Xi'an Eyedeal Medical Technology Co., Ltd
Timeline & Enrollment
N/A
Feb 01, 2024
Feb 01, 2025
Primary Outcome
SAFETY OUTCOME MEASURE - Adverse event,PERFORMANCE OUTCOME MEASURE - uncorrected distance visual acuity (UCDVA),PERFORMANCE OUTCOME MEASURE - Corrected distance visual acuity (CDVA)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06223113
Device Trial