Astigmatism
Conditions
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).
Interventions
PROCEDURECATARACT SURGERY
Approximately up to 100 subjects (100 eyes) will be successfully implanted with an enVista Toric IOL (Model MX60ET) in one or both eyes.
Sponsors
Bausch & Lomb Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint | 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. | 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 |
Countries
United States
Outcome results
None listed