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AstigmatismNCT05739656

Evaluation of Visual Acuity of the Envista One-piece Acrylic Toric IOL MX60ET

An observational study of Astigmatism, run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to evaluate rotational stability and functional improvements in visual acuity of the enVista monofocal Toric IOL (MX60ET) following cataract surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Astigmatism
What is being tested?
CATARACT SURGERY
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteUnited States
Study dates
1 Aug 2020to 6 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Approximately up to 100 subjects (100 eyes) will be successfully implanted with an enVista Toric IOL (Model MX60ET) in at least one eye. For subjects with pre-existing cataracts in both eyes requiring removal and IOL implantation, the eye with the worse BCDVA at the preoperative visit will be designated the study eye. If BCDVA is the same for both eyes, the right eye will be designated the study eye. Only the study eye data will be collected, and binocular visual acuities will not captured. Postoperatively, all subjects will undergo ophthalmic examinations at regular intervals per the study visit schedule through Form 4 (120-180 days postoperative).

Who may be able to join

  • Subjects must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)-approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
  • Subjects must be able and willing to comply with all treatment and follow-up/study procedures.
  • Subjects must be 18 years of age or older on the date the ICF is signed.
  • Subjects must have best-corrected distance visual acuity (BCDVA) equal to or worse than 20/40 in the study eye, with or without glare source, due to a clinically significant cataract (either cortical, nuclear, subcapsular, or a combination) that is considered amenable to treatment with standard phacoemulsification cataract extraction.
  • Subjects must require a spherical equivalent lens power from 17.0 D to 24.0 D in the study eye.
  • Subjects must have a BCDVA projected to be better than 20/30 after toric IOL implantation in the study eye (as determined by the medical judgment of the Investigator or measured by potential VA testing if necessary).
Show all 12Show fewer
  • Subjects must have a preoperative corneal astigmatism between 0.77 D and 4.53 D in the study eye.
  • Subject must have a dilated preoperative pupil size greater than or equal to 5.0 mm in the study eye.
  • Contact lens wearers need to demonstrate a stable refraction (within
  • ±0.50 D) in the study eye, as determined by manifest refraction spherical equivalent (MRSE) on two consecutive examination dates. Stability of the refraction is determined under the following conditions:
  • Lenses are not worn for at least 2 weeks (rigid or toric contact lenses) or 3 days (soft contact lenses) prior to the first refraction used to establish stability and through the day of surgery.
  • The two refractions are performed at least 7 days apart.

Who cannot join

  • This study will exclude subjects who meet none of the following exclusion criteria:
  • Subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery (eg, chronic uveitis, iritis, iridocyclitis, rubeosis iridis, clinically significant corneal dystrophy, clinically significant Fuchs' dystrophy, clinically significant anterior membrane dystrophy, etc).
  • Subjects with associated ocular conditions which could affect the stability of the IOL (eg, traumatic zonulolysis, zonular dialysis, evident zonular weakness or dehiscence, etc) in the study eye.
  • Subjects with clinically significant irregular corneal astigmatism in the study eye, as determined by the medical judgment of the Investigator.
  • Subjects with clinically significant corneal pathology potentially affecting topography of either eye.
  • Subjects with any ocular condition (eg, amblyopia) that could prevent the possibility of a visual outcome better than 20/30 in the study eye.
  • Subjects with an anterior chamber depth < 2.0 mm as measured by the IOL master/LENSTAR in the study eye.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Jeffrey Whitman, MD

    Dallas, Texas, 75243

Other trials in United States

About this study

Official title: A PROSPECTIVE, MULTICENTER, POST-MARKET OBSERVATIONAL STUDY TO EVALUATE ROTATIONAL STABILITY AND FUNCTIONAL VISUAL ACUITY OF THE ENVISTA ONE-PIECE HYDROPHOBIC ACRYLIC TORIC IOL MX60ET FOLLOWING CATARACT SURGERY PROTOCOL.

The primary objective of this study is to evaluate rotational stability and functional improvements in visual acuity of the enVista monofocal Toric IOL (MX60ET) following cataract surgery.

Read the detailed description

This is a prospective, multicenter, post-market observational study at approximately 5 sites in the United States. All clinical sites will have Institutional Review Board (IRB) approval prior to recruiting potential subjects. All subjects who meet eligibility criteria will be consecutively offered enrollment into the trial. Approximately up to 100 subjects (100 eyes) will be successfully implanted with an enVista Toric IOL (Model MX60ET) in one or both eyes at up to 5 clinical sites in the United States. For subjects with pre-existing cataracts in both eyes requiring removal and IOL implantation, the eye with the worse BCDVA at the preoperative visit will be designated the study eye. If BCDVA is the same for both eyes, the right eye will be designated the study eye. Postoperatively, all subjects will undergo ophthalmic examinations at regular intervals per the study visit schedule through Form 4 (120-180 days postoperative).

Conditions
Astigmatism
Being tested
CATARACT SURGERY
Medical subject headings
Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CATARACT SURGERYProcedure or surgery

    Also called The enVista One-Piece Hydrophobic Acrylic Toric IOL

    Approximately up to 100 subjects (100 eyes) will be successfully implanted with an enVista Toric IOL (Model MX60ET) in one or both eyes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Effectiveness Endpoint

    The proportion of subjects with absolute lens axis rotation from surgical placement of less than or equal to 20 degrees. Tertiary/Supportive/Other effectiveness outcomes will include the following.

    • Uncorrected and distance-corrected visual acuities at 66 cm and at 4 m
    • Manifest refraction
    • Subjective questionnaire

    Measured: The duration of the study, including the time to recruit all subjects, will be up to 12 months. Eligible subjects who are enrolled in the study will be seen for up to 6 months after implantation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study start1 Aug 2020
  3. Primary completion6 Jul 2022
  4. Study completion6 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05739656
Sponsor's protocol ID
897
Status last verified
Jan 2023
First submitted
17 Jan 2023
Last updated
22 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Holladay JT, Haller M. Light-adjustable lens results of spherical equivalent and astigmatism correction from the U.S. Food and Drug Administration postapproval study. J Cataract Refract Surg. 2026 Jul 1;52(7):666-669. doi: 10.1097/j.jcrs.0000000000001906.

    PubMed 41664266

Questions about this trial

What is this clinical trial studying?

An observational study of Astigmatism, run by Bausch & Lomb Incorporated at 1 site in United States.

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 12 inclusion and 7 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: finished, as of the sponsor's last update on 22 Feb 2023. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Primary Effectiveness Endpoint (time frame: The duration of the study, including the time to recruit all subjects, will be up to 12 months. Eligible subjects who are enrolled in the study will be seen for up to 6 months after implantation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05739656, which also lists 1 linked publication.

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 22 Feb 2023.

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