CataractNCT06479148
Clinical Evaluation of the Performance of the enVista® Aspire™ (EA) Lens
A study testing enVista® Aspire™, An IOL with a slightly extended depth of focus and MX60E in people with Cataract, run by Bausch & Lomb Incorporated at 1 site in Honduras.
Trial summary
A Prospective, Single-Center, Randomized Clinical Investigation to evaluate the safety and performance of the enVista® Aspire ™ (EA) intraocular lens (IOL) when compared to the MX60E monofocal IOL (control lens) and an IOL with a slightly extended depth of focus (active comparator lens) for potentially improved… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- enVista® Aspire™, An IOL with a slightly extended depth of focus and MX60E
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteHonduras
- Study dates
- 15 Aug 2024to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
- Subjects must have the capability to understand and provide informed consent on the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) and authorization as appropriate for local privacy regulations.
- Subjects must have a Best-corrected Distance Visual Acuity (BCDVA) 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.
- Subjects must have a BCDVA projected to be better than 20/32 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.
- Have discontinued use of contact lenses for at least 2 weeks (for hard or toric lenses) or 3 days (for soft contact lenses) prior to the pre-operative examination, and through the day of surgery and must be willing to refrain from use of contact lenses throughout the clinical investigation.
Show all 9Show fewer
- Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere and cylinder) in both eyes, as determined by distance manifest refraction on two consecutive examination dates at least one week apart after discontinuation of contact lens wear.
- Subjects must require an IOL power from +18.0 diopter (D) to +26.0 D in both eyes.
- Subjects must be willing and able to comply with all treatment and follow-up Clinical Investigation visits and procedures, and to undergo second eye surgery on the same day as the first eye surgery. Illiterate subjects must be able to identify letters as required for the assessments.
Who cannot join
- Subjects who have used an investigational drug or device within 30 days prior to screening visit and/or will participate in another investigation during the period of Clinical Investigation participation.
- Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in either eye. Stable pterygium that minimally encroaches on the corneal surface is allowed.
- Subjects who have significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, traumatic cataract, lens subluxation, traumatic zonulolysis, zonular dialysis, evident zonular weakness or dehiscence, hypermature or brunescent cataract, etc.) in either eye.
- Subjects who have uncontrolled glaucoma in either eye.
- Subjects who have previous retinal detachment or clinically significant retinal pathology involving the macula in either eye.
- Subjects who have proliferative or non-proliferative diabetic retinopathy in either eye.
Show all 20Show fewer
- Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract) in either eye.
- Subjects using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure within 30 days of enrollment or during the Clinical Investigation.
- Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis) in either eye.
- Subjects who have a visual disorder, other than cataracts, that could potentially cause future acuity losses to a level of BCDVA 20/100 or worse in either eye.
- Subjects who have had previous intraocular or corneal surgery in either eye, with the exception of laser trabeculoplasty.
- Subjects with any preoperative infectious conjunctivitis, keratitis, or uveitis in either eye within 30 days prior to enrollment.
- Subjects who have a preoperative corneal astigmatism ≥ 2.0 D in either eye as confirmed by Corneal Topography, irregular astigmatism, or skewed radial axis (note: corneal incisions intended specifically to reduce astigmatism are not allowed during the Clinical Investigation).
- Subjects who cannot achieve a minimum pharmacologic pupil dilation of 5.0 mm in both eyes.
- Subjects who may be expected to require a combined or other secondary surgical procedure in either eye.
- Subjects who during the first cataract extraction experience an anterior or posterior capsule tear or rupture, zonular dialysis, significant iris trauma, or other complication that may cause untoward effects in the judgment of the Principal Investigator.
- Females of childbearing potential (those who are not surgically sterilized or at least 12 months postmenopausal) are excluded from enrollment in the Clinical Investigation if they are currently pregnant or plan to become pregnant during the Clinical Investigation. Females of childbearing potential must be willing to practice effective contraception for the duration of the Clinical Investigation.
- Subjects with any other serious ocular pathology or underlying systemic medical condition (e.g., uncontrolled diabetes) or circumstance that, based on the Principal Investigator's judgment, poses a concern for the subjects' safety or could confound the results of the Clinical Investigation.
- Subjects who have current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g., Flomax® (tamsulosin hydrochloride (HCl)), Terazosin, or Cardura).
- Subjects with abnormal pupillary dilation dynamics (as determined by the medical judgment of the Principal Investigator) or eccentric or ectopic pupils in either eye.
Trial locations and contacts
1 site in 1 country.
Honduras1 site
Site 101 Centro Oftalmológico Robles
Santa Rosa de Copán, Copán Department, 41101
About this study
Official title: A Prospective, Single-Center, Randomized Clinical Investigation to Evaluate the Performance of enVista® Aspire ™ (EA) Intraocular Lens Against a Control and an Active-Comparator in Subjects Undergoing Cataract Extraction and Implantation of an Intraocular Lens
A Prospective, Single-Center, Randomized Clinical Investigation to evaluate the safety and performance of the enVista® Aspire ™ (EA) intraocular lens (IOL) when compared to the MX60E monofocal IOL (control lens) and an IOL with a slightly extended depth of focus (active comparator lens) for potentially improved optical properties.
- Conditions
- Cataract
- Being tested
- enVista® Aspire™, An IOL with a slightly extended depth of focus, MX60E
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enVista® Aspire™Device
Eyes will receive enVista® Aspire™ lenses
An IOL with a slightly extended depth of focusDevice
Eyes will receive lenses with a slightly extended depth of focus
MX60EDevice
Eyes will receive MX60E lenses
| Study group | Role | What they receive |
|---|---|---|
| enVista® Aspire ™ | Experimental | Not described Receives: Device: enVista® Aspire™ |
| An IOL with a slightly extended depth of focus | Active comparator | Not described Receives: Device: An IOL with a slightly extended depth of focus |
| enVista® Monofocal IOL (MX60E) | Other | Other Receives: Device: MX60E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photopic Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm at Post-operative Visit 3
Photopic binocular distance corrected intermediate visual acuity (DCIVA) at 66 cm at post-operative visit 3
Measured: Assessed from Day 90 to Day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start15 Aug 2024
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Why it stopped: No additional clinical evidence is required within the scope of this clinical investigation. No safety concern related to any IOL have been identified
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479148
- Sponsor's protocol ID
- 927
- Status last verified
- May 2026
- First submitted
- 24 Jun 2024
- Last updated
- 26 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Randomized Clinical Investigation to Evaluate the Performance of enVista® Aspire ™ (EA) Intraocular Lens Against a Control and an Active-Comparator in Subjects Undergoing Cataract Extraction and Implantation of an Intraocular Lens
- ClinicalTrials.gov ID
- NCT06479148
- Acronym / sponsor ID
- 927
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No additional clinical evidence is required within the scope of this clinical investigation. No safety concern related to any IOL have been identified
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 28 Jun 2024 (actual)
- Results
- Posted 26 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective, Single-Center, Randomized Clinical Investigation to evaluate the safety and performance of the enVista® Aspire ™ (EA) intraocular lens (IOL) when compared to the MX60E monofocal IOL (control lens) and an IOL with a slightly extended depth of focus (active comparator lens) for potentially improved optical properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| enVista® Aspire ™ | Experimental | Device: enVista® Aspire™ |
| An IOL with a slightly extended depth of focus | Active comparator | Device: An IOL with a slightly extended depth of focus |
| enVista® Monofocal IOL (MX60E) | Other | Device: MX60EOther |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
- Subjects must have the capability to understand and provide informed consent on the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) and authorization as appropriate for local privacy regulations.
- Subjects must have a Best-corrected Distance Visual Acuity (BCDVA) 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.
- Subjects must have a BCDVA projected to be better than 20/32 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.
Key exclusion criteria (20 listed)
- Subjects who have used an investigational drug or device within 30 days prior to screening visit and/or will participate in another investigation during the period of Clinical Investigation participation.
- Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in either eye. Stable pterygium that minimally encroaches on the corneal surface is allowed.
- Subjects who have significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, traumatic cataract, lens subluxation, traumatic zonulolysis, zonular dialysis, evident zonular weakness or dehiscence, hypermature or brunescent cataract, etc.) in either eye.
- Subjects who have uncontrolled glaucoma in either eye.
- Subjects who have previous retinal detachment or clinically significant retinal pathology involving the macula in either eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enVista® Aspire™Eyes will receive enVista® Aspire™ lenses | Device | enVista® Aspire ™ |
| An IOL with a slightly extended depth of focusEyes will receive lenses with a slightly extended depth of focus | Device | An IOL with a slightly extended depth of focus |
| MX60EEyes will receive MX60E lenses | Device | enVista® Monofocal IOL (MX60E) |
Primary outcome
Photopic Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm at Post-operative Visit 3
Time frame: Assessed from Day 90 to Day 150
Photopic binocular distance corrected intermediate visual acuity (DCIVA) at 66 cm at post-operative visit 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enVista® Aspire™, An IOL with a slightly extended depth of focus and MX60E in people with Cataract, run by Bausch & Lomb Incorporated at 1 site in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photopic Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm at Post-operative Visit 3 (time frame: Assessed from Day 90 to Day 150). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.