A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction

Recruiting

• Conditions: Cataract
• Interventions: Device: enVista Aspire EA IOLs

• Registration Number: NCT06333028
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

A Study to Evaluate the enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction

Detailed Description

A Non-interventional, Prospective, Multicenter, Single Arm, Post-Marketing Clinical Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction

Study Timeline

• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-27
• Study Start: 2024-05-30
• Status Verified: 2024-12
• Primary Completion: 2024-12
• Study Completion: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
2. Subjects with a post operative BCDVA of 20/40 or better.
3. 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.
4. 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.
5. 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.

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Exclusion Criteria

1. 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.
2. Subjects with preoperative corneal astigmatism > 1.0 D in either eye, preoperative irregular astigmatism, or preoperative skewed radial axis.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
enVista Aspire intraocular lens (IOL)	enVista Aspire EA IOLs	Subjects bilaterally implanted with enVista Aspire EA IOLs.

Primary Outcome Measures

Name	Time	Method
Mean binocular BCDVA (logMAR) at Visit 1	Day 60 to Day 270 after second eye implantation	Mean binocular best-corrected distance visual acuity (BCDVA) (logMAR) at Visit 1. Photopic BCDVA measured at 4 meters.

Trial Locations

Locations (7)

Site 107; 🇺🇸 Cranberry Township, Pennsylvania, United States

SITE 104; 🇺🇸 Dover, New Jersey, United States

Site 105; 🇺🇸 Woodland Park, New Jersey, United States

Site 103; 🇺🇸 Garden City, New York, United States

Site 106; 🇺🇸 Charleston, South Carolina, United States

Site 101; 🇺🇸 Sugar Land, Texas, United States

Site 102; 🇺🇸 Mount Pleasant, Wisconsin, United States