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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06333028
• Other study ID #: 938
• Status: Recruiting
• Start date: May 30, 2024
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Bausch & Lomb Incorporated
• Contact: Rosangela Nolasco
• Phone: 949-259-1633
• Email: Rosangela.Nolasco2[@]bausch.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• enVista Aspire EA IOLs
Subjects bilaterally implanted with enVista Aspire EA IOLs

Locations

Country	Name	City	State
United States	Site 106	Charleston	South Carolina
United States	SITE 104	Dover	New Jersey
United States	Site 103	Garden City	New York
United States	Site 102	Mount Pleasant	Wisconsin
United States	Site 101	Sugar Land	Texas
United States	Site 105	Woodland Park	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 90 to Day 180 after second eye implantation