A Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects Undergoing Cataract Extraction

Not Applicable

Recruiting

• Conditions: Cataract
• Interventions: Device: enVista Aspire EA or Aspire Toric ETA IOLs

• Registration Number: NCT06594185
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

A study to evaluate the real-world clinical performance of the enVista Aspire and Aspire Toric intraocular lens (IOL) models EA and ETA and to assess surgeon and subject satisfaction

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-29
• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
2. Subjects must be capable of understanding and providing informed consent on the Institutional Review Board (IRB)- approved Informed Consent Form (ICF) and authorization as appropriate for local privacy regulations.
3. Have a BCDVA at or worse than 20/40 in each eye, with or without a glare source, due to a clinically significant cataract (cortical, nuclear, subcapsular, or combination) that is considered amenable to treatment with standard phacoemulsification cataract extraction and capsular IOL implantation.
4. Have a BCDVA projected to be better than 20/30 after IOL implantation in each eye as determined by the medical judgment of the Principal Investigator.
5. Subjects must have clear intraocular media other than the cataract in both eyes.
6. Subjects must require an IOL power from +6.0 diopter (D) to +34.0 diopter (D) in both eyes.
7. Subjects with clinically significant preoperative corneal astigmatism must require an IOL toric power between 1.25 diopter (D) to 5.75 diopter (D).
8. Subjects must be willing and able to comply with all treatment and follow-up Clinical Investigation visits and procedures

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Exclusion Criteria

1. Pre-existing ocular conditions (subjects with prior corneal refractive surgery, irregular corneal astigmatism, severe (clinically significant) corneal dystrophy, e.g., Fuch's, macular disease, optic nerve atrophy, corneal endothelial disease, abnormal cornea, macular degeneration, retinal degeneration, and chronic drug miosis, who may not achieve the visual acuity of patients without such problems, etc.)
2. Associated ocular conditions that could affect the stability of the IOL (e.g., traumaticzonulolysis, zonular dialysis, evident zonular weakness or dehiscence, etc.) in the study eye.
3. Retinal conditions, or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or proliferative diabetic retinopathy, in which future treatment may be compromised by implanting this IOL
4. Amblyopia
5. Rubella, congenital, traumatic, or complicated cataracts
6. Extremely shallow anterior chamber, not due to swollen cataract
7. Recurrent anterior or posterior segment inflammation of unknown etiology, or any disease producing an inflammatory reaction (e.g., iritis or uveitis)
8. Aniridia
9. Iris neovascularization
10. Subjects who have uncontrolled glaucoma in either eye. Uncontrolled glaucoma is defined as intraocular pressure (IOP) greater than 21 mm Hg in spite of maximally tolerated medications (with more than three topical drugs for IOP control).
11. Microphthalmos or macrophthalmos
12. Previous corneal transplant, prior YAG laser iridotomy, YAG vitreolysis, and prior phakic IOL insertions.
13. Pre-existing ocular conditions that may negatively impact the stability of the implant or intraoperative conditions (posterior capsular rupture, complications in which the IOL stability could be compromised, inability to place IOL in capsular bag, etc.).
14. Mechanical or surgical manipulation required to enlarge the pupil
15. Vitreous loss (significant)
16. Anterior chamber bleeding (significant)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects bilaterally implanted with enVista Aspire EA or Aspire Toric ETA IOLs	enVista Aspire EA or Aspire Toric ETA IOLs	-

Primary Outcome Measures

Name	Time	Method
Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1	Assessed at Postop visit 1 (Day 14 to 42 days after second eye IOL implantation)	Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1
Percentage of subjects with binocular BCDVA of 20/40 or better at Postoperative Visit 1	Assessed at Postop visit 1 (Day 14 to 42 days after second eye IOL implantation)	Percentage of subjects with binocular BCDVA of 20/40 or better at Postoperative Visit 1

Trial Locations

Locations (20)

Site 118; 🇺🇸 Birmingham, Alabama, United States

Site 105; 🇺🇸 Tucson, Arizona, United States

Site 104; 🇺🇸 Bakersfield, California, United States

Site 101; 🇺🇸 Beverly Hills, California, United States

Site 111; 🇺🇸 Huntington Beach, California, United States

Site 109; 🇺🇸 Newport Beach, California, United States

Site 112; 🇺🇸 Orange, California, United States

Site 119; 🇺🇸 Torrance, California, United States

Site 115; 🇺🇸 Upland, California, United States

Site 108; 🇺🇸 Rock Island, Illinois, United States

Site 116; 🇺🇸 Bowie, Maryland, United States

Site 102; 🇺🇸 Bloomington, Minnesota, United States

Site 106; 🇺🇸 Kansas City, Missouri, United States

Site 117; 🇺🇸 S. Sioux City, Nebraska, United States

Site 114; 🇺🇸 South Orange, New Jersey, United States

Site 120; 🇺🇸 New York, New York, United States

Site 107; 🇺🇸 W. Fargo, North Dakota, United States

Site 103; 🇺🇸 Brecksville, Ohio, United States

Site 113; 🇺🇸 Beaumont, Texas, United States

Site 110; 🇺🇸 Dallas, Texas, United States