Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction

Launched by BAUSCH & LOMB INCORPORATED · Mar 20, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the safety and effectiveness of a special type of lens called the enVista® Beyond Intraocular Lens (IOL) for people undergoing cataract surgery. Cataracts can cause cloudy vision, and this study is looking to see how well this new lens works in improving vision after it is implanted in both eyes.

To participate in the trial, you need to be at least 22 years old and have vision that is 20/40 or worse in each eye due to cataracts. You should also be able to understand and sign a consent form. If you join, you can expect to have the lens implanted in both eyes, with the second surgery happening within 7 to 30 days after the first. The study is currently seeking volunteers of all genders, and if you meet the eligibility criteria, you could play an important role in helping determine if this new lens is a good option for cataract treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
• • 2. Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB) approved ICF and authorization as appropriate for local privacy regulations.
• • 3. Subjects must have a BCDVA equal to or worse than 20/40 in each eye, with or without a glare source present (Brightness Acuity Tester), or have significant cataract-related visual symptoms, 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.
• • 4. Subjects must have preoperative corneal astigmatism less than 1.0 D for each eye.
• • 5. Subjects must have a BCDVA projected to be better than 20/30 after cataract removal and IOL implantation in each eye, as determined by the medical judgment of the Investigator or measured by potential acuity meter (PAM) testing, if necessary.
• • 6. Subjects must have clear intraocular media other than the cataract in both eyes.
• • 7. Contact lens wearers must demonstrate a stable refraction (within ±0.50 D in magnitude for both sphere and cylinder and within ±15° in axis) in both eyes, as determined by distance manifest refraction on two consecutive examination dates (both refractions performed at least 7 days apart) after discontinuation of contact lens wear (Rigid or Toric lenses discontinued for at least 2 weeks and soft contact lenses discontinued for at least 3 days prior to the first refraction used to establish stability and through the day of surgery).
• • 8. Subjects must require an IOL power from +14.0 diopter (D) to +28.0 D for each eye.
• • 9. Subjects must be willing and able to comply with all treatment and follow-up study visits and procedures, and to undergo second eye surgery within 7-30 days of the first eye surgery.
• Exclusion Criteria:
• • 1. Subjects who have used an investigational drug or device within 30 days prior to the planned first surgery date and/or will participate in another investigation during the period of study participation.
• • 2. Subjects with presence of any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.), not including mild superficial punctate keratitis (SPK) (confirmed by corneal staining), in either eye.
• • 3. Subjects with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens.
• • 4. Subjects who have uncontrolled glaucoma in either eye. Uncontrolled glaucoma is defined as intraocular pressure (IOP) greater than 21 mm Hg in spite of maximally tolerated medications (with more than 3 topical drugs for IOP control).
• • 5. Subjects with previous retinal detachment or presence or history of clinically significant retinal pathology involving the macula in either eye.
• • 6. Subjects with presence of proliferative or non-proliferative diabetic retinopathy in either eye.
• • 7. Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract) in either eye.
• • 8. Subjects using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure within 30 days of randomization (refer to the relevant attachment of the Study Reference Manual).
• • 9. Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis) in either eye.
• • 10. Subjects with presence or history of diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are expected to cause future visual acuity losses to a level of 20/30 or worse in either eye.
• • 11. Subjects who have had previous intraocular or corneal surgery in either eye that might confound the outcome of the investigation or increase the risk to the subject.
• • 12. Subjects with any active infectious conjunctivitis, keratitis, or uveitis in either eye.
• • 13. Subjects who have irregular astigmatism or skewed radial axis for either eye.
• • 14. Subjects who cannot achieve a minimum pharmacologic pupil dilation of at least 5.0 mm in both eyes.
• • 15. Subjects who may be expected to require a combined or other secondary surgical procedure in either eye (note: corneal incisions intended specifically to reduce astigmatism are not allowed during the study).
• • 16. Females of childbearing potential (those who are not surgically sterilized or at least 12 months postmenopausal) are excluded from enrollment in the study if they are currently pregnant or plan to become pregnant during the study, lactating or have a condition associated with fluctuation hormones that could lead to refractive changes. Females of childbearing potential must be willing to practice effective contraception for the duration of their participation in the study.
• • 17. Subjects with any other serious ocular pathology or underlying systemic medical disease (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, poses a concern for the subjects' safety, increases the operative risk or could confound the results of the study.
• • 18. Subjects who have current or previous usage of systemic medications that may confound the outcome or increase the risk to the subject based on the Investigator's judgement. For example; subjects on an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g., tamsulosin hydrochloride (Flomax®), Terazosin, Rapaflo or Cardura) or other medications with similar side effects (floppy iris syndrome).
• • 19. Subjects who are expected to require retinal laser treatment.