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NCT06223113Not yet recruiting

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
Xi'an Eyedeal Medical Technology Co., LtdClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Cataract
Drug/Device/Intervention
EyenableTM PA60AS1 IOL
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Xi'an Eyedeal Medical Technology Co., Ltd
Timeline & enrollment
Phase
N/A
Start date
Feb 01, 2024
End date
Feb 01, 2025
Enrollment
200 participants
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
Other cataractCataract, unspecifiedComplicated cataractOther specified cataractSenile cataract
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06223113
Type
Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.