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New lens study shows clearer vision after cataract surgery

NCT ID NCT06594185

Disease control Sponsor: Bausch & Lomb Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how well enVista Aspire intraocular lenses work in real-world cataract surgery. 335 adults received the lenses during routine cataract removal. Researchers measured vision sharpness and how satisfied patients and surgeons were with the results.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
enVista Aspire EA and Aspire Toric ETA intraocular lenses (implantable devices)
What this could lead to
If successful, this study confirms that these lenses improve vision and satisfaction after cataract surgery in everyday practice.
What could go wrong
This is a completed post-marketing study, so results are already known. It does not test a new treatment, only real-world performance of an existing device.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

335 people

The number who actually took part.

Started

Aug 2024

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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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Conditions

The condition(s) this trial relates to.

cataract

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cataract

Contacts and locations

Locations

  • Site 101

    Beverly Hills, California, 90210, United States

  • Site 102

    Bloomington, Minnesota, 55420, United States

  • Site 103

    Brecksville, Ohio, 44142, United States

  • Site 104

    Bakersfield, California, 93309, United States

  • Site 105

    Tucson, Arizona, 85704, United States

  • Site 106

    Kansas City, Missouri, 64133, United States

  • Site 107

    West Fargo, North Dakota, 58078, United States

  • Site 108

    Rock Island, Illinois, 61201, United States

  • Site 109

    Newport Beach, California, 92707, United States

  • Site 110

    Dallas, Texas, 75243, United States

  • Site 111

    Huntington Beach, California, 92647, United States

  • Site 112

    Orange, California, 92868, United States

  • Site 113

    Beaumont, Texas, 77707, United States

  • Site 114

    South Orange, New Jersey, 07079, United States

  • Site 115

    Upland, California, 91786, United States

  • Site 117

    South Sioux City, Nebraska, 68776, United States

  • Site 118

    Birmingham, Alabama, 35209, United States

  • Site 119

    Torrance, California, 90505, United States

  • Site 121

    Alexandria, Minnesota, 56308, United States

  • Site 122

    Salt Lake City, Utah, 84107, United States

  • Site 123

    San Antonio, Texas, 78209, United States

  • Site 124

    San Antonio, Texas, 78229, United States

  • Site 125

    Bradenton, Florida, 34209, United States

  • Site 126

    Long Beach, California, 90805, United States

  • Site 127

    Tarpon Springs, Florida, 34689, United States

  • Site 128

    Bozeman, Montana, 59718, United States

  • Site 129

    Cincinnati, Ohio, 45242, United States

  • Site 130

    Milford, Connecticut, 06460, United States

  • Site 131

    Birmingham, Michigan, 48009, United States

  • Site 133

    Shreveport, Louisiana, 71103, United States

  • Site 135

    Medford, Oregon, 97504, United States

  • Site 136

    Mesa, Arizona, 85202, United States

  • Site 137

    Chandler, Arizona, 85224, United States

  • Site 138

    Goldsboro, North Carolina, 27534, United States

  • Site 140

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Site 141

    Houston, Texas, 77055, United States

  • Site 142

    Alexandria, Minnesota, 56308, United States

  • Site 143

    Pompano Beach, Florida, 33064, United States

  • Site 144

    Pasadena, California, 91107, United States

  • Site 145

    Austin, Texas, 78704, United States

  • Site 147

    Houston, Texas, 77008, United States

  • Site 148

    Mt. Dora, Florida, 32757, United States

  • Site 149

    Los Angeles, California, 90024, United States

  • Site 150

    Allenwood, Pennsylvania, 17810, United States

  • Site 151

    Hemet, California, 92543, United States

  • Site 152

    Bend, Oregon, 97701, United States

  • Site 153

    Winter Park, Florida, 32792, United States

  • Site 154

    Bullhead City, Arizona, 86442, United States

  • Site 155

    Murrieta, California, 92562, United States

  • Site 156

    Leland, North Carolina, 28451, United States

  • Site 157

    Kingston, Pennsylvania, 18704, United States

  • Site 158

    Austin, Texas, 78731, United States

  • Site 159

    Albuquerque, New Mexico, 87109, United States

  • Site 160

    Honolulu, Hawaii, 96814, United States

  • Site 161

    Greenwich, Connecticut, 06830, United States

  • Site 162

    Phoenix, Arizona, 85028, United States

  • Site 163

    Honolulu, Hawaii, 96813, United States

  • Site 164

    Stamford, Connecticut, 06902, United States

  • Site 165

    Roswell, Georgia, 30076, United States

  • Site 166

    Moore, Oklahoma, 73160, United States

  • Site132

    Poughkeepsie, New York, 12603, United States

  • Site134

    Gainesville, Georgia, 30501, United States

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