A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction
A Non-interventional, Prospective, Multicenter, Single Arm, Post-Marketing Clinical Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction.
1 other identifier
observational
82
1 country
7
Brief Summary
A Study to Evaluate the enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2024
Shorter than P25 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2024
CompletedFirst Posted
Study publicly available on registry
March 27, 2024
CompletedStudy Start
First participant enrolled
May 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2025
CompletedMay 2, 2025
April 1, 2025
10 months
March 20, 2024
April 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Mean binocular BCDVA (logMAR) at Visit 1
Mean binocular best-corrected distance visual acuity (BCDVA) (logMAR) at Visit 1. Photopic BCDVA measured at 4 meters.
Day 60 to Day 270 after second eye implantation
Study Arms (1)
enVista Aspire intraocular lens (IOL)
Subjects bilaterally implanted with enVista Aspire EA IOLs.
Interventions
Subjects bilaterally implanted with enVista Aspire EA IOLs
Eligibility Criteria
Patient population at study site locations
You may qualify if:
- Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
- Subjects with a post operative BCDVA of 20/40 or better.
- Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB) approved ICF and authorization as appropriate for local privacy regulations and willing and able to comply with the follow-up study visit.
- Subjects implanted bilaterally with enVista Aspire EA IOLs, powers ranging from + 6 to + 34.0 D, prior to enrollment into the study on or after 1 November 2023.
- All subjects with a visually significant PCO (BCDVA worse than 20/40) who undergo a YAG capsulotomy may be enrolled 30 days post YAG procedure and with a postoperative BCDVA 20/40 or better.
You may not qualify if:
- Subjects with any serious ocular pathology or underlying systemic medical disease (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, could confound the results of the study.
- Subjects for whom a Toric IOL is indicated to achieve emmetropia.
- Subjects for whom monovision treatment is planned.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
SITE 104
Dover, New Jersey, 07801, United States
Site 105
Woodland Park, New Jersey, 07424, United States
Site 103
Garden City, New York, 11530, United States
Site 107
Cranberry Township, Pennsylvania, 16066, United States
Site 106
Charleston, South Carolina, 29407, United States
Site 101
Sugar Land, Texas, 77478, United States
Site 102
Mount Pleasant, Wisconsin, 53405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2024
First Posted
March 27, 2024
Study Start
May 30, 2024
Primary Completion
March 13, 2025
Study Completion
March 13, 2025
Last Updated
May 2, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share