A Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intrao… (NCT06594185) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects Undergoing Cataract Extraction
United States335 participantsStarted 2024-08-29
Plain-language 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
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
. 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.
. 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.
. 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.
. Subjects must have clear intraocular media other than the cataract in both eyes.
. Subjects must require an IOL power from +6.0 diopter (D) to +34.0 diopter (D) in both eyes.
. Subjects with clinically significant preoperative corneal astigmatism must require an IOL toric power between 1.25 diopter (D) to 5.75 diopter (D).
. Subjects must be willing and able to comply with all treatment and follow-up Clinical Investigation visits and procedures
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1
Timeframe: Assessed at Postop visit 1 (Day 14 to 42 days after second eye IOL implantation)
2
Percentage of subjects with binocular BCDVA of 20/40 or better at Postoperative Visit 1
Timeframe: Assessed at Postop visit 1 (Day 14 to 42 days after second eye IOL implantation)
. 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.)
. 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.
. 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
. Amblyopia
. Rubella, congenital, traumatic, or complicated cataracts
. Extremely shallow anterior chamber, not due to swollen cataract
. Recurrent anterior or posterior segment inflammation of unknown etiology, or any disease producing an inflammatory reaction (e.g., iritis or uveitis)