Clinical trial NCT05739656: Evaluation of Visual Acuity of the Envista One-piece Acrylic Toric IOL MX60ET
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Astigmatism
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2023-02-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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).
* 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Jeffrey Whitman, MD
state: Texas
Study officials:
References: