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

Not Applicable

Recruiting

• Conditions: Cataract

• Registration Number: NCT06333015
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-3-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Subjects must be 22 years of age or older on the date the Informed Consent Form<br> (ICF) is signed.<br><br> 2. Subjects must have the capability to understand and provide written informed consent<br> on the Institutional Review Board (IRB)/Research Ethics Board (REB) approved ICF and<br> authorization as appropriate for local privacy regulations.<br><br> 3. Subjects must have a BCDVA equal to or worse than 20/40 in each eye, with or without<br> a glare source present (Brightness Acuity Tester), or have significant<br> cataract-related visual symptoms, due to a clinically significant cataract<br> (cortical, nuclear, subcapsular, or combination) that is considered amenable to<br> treatment with standard phacoemulsification cataract extraction and capsular IOL<br> implantation.<br><br> 4. Subjects must have preoperative corneal astigmatism less than 1.0 D for each eye.<br><br> 5. Subjects must have a BCDVA projected to be better than 20/30 after cataract removal<br> and IOL implantation in each eye, as determined by the medical judgment of the<br> Investigator or measured by potential acuity meter (PAM) testing, if necessary.<br><br> 6. Subjects must have clear intraocular media other than the cataract in both eyes.<br><br> 7. Contact lens wearers must demonstrate a stable refraction (within ±0.50 D in<br> magnitude for both sphere and cylinder and within ±15° in axis) in both eyes, as<br> determined by distance manifest refraction on two consecutive examination dates<br> (both refractions performed at least 7 days apart) after discontinuation of contact<br> lens wear (Rigid or Toric lenses discontinued for at least 2 weeks and soft contact<br> lenses discontinued for at least 3 days prior to the first refraction used to<br> establish stability and through the day of surgery).<br><br> 8. Subjects must require an IOL power from + 16.0 diopter (D) to + 24.0 D for each eye.<br><br> 9. Subjects must be willing and able to comply with all treatment and follow-up study<br> visits and procedures, and to undergo second eye surgery within 7-30 days of the<br> first eye surgery.<br><br>Exclusion Criteria:<br><br> 1. Subjects who have used an investigational drug or device within 30 days prior to the<br> planned first surgery date and/or will participate in another investigation during<br> the period of study participation.<br><br> 2. Subjects who have any corneal pathology (e.g., significant scarring, guttata,<br> inflammation, edema, dystrophy, etc.) in either eye.<br><br> 3. Subjects with conditions that increase the risk of zonular rupture during cataract<br> extraction procedure that may affect the postoperative centration or tilt of the<br> lens<br><br> 4. Subjects who have uncontrolled glaucoma in either eye. Uncontrolled glaucoma is<br> defined as intraocular pressure (IOP)>21 mm Hg in spite of maximally tolerated<br> medications (with more than 3 topical drugs for IOP control).<br><br> 5. Subjects with previous retinal detachment or clinically significant retinal<br> pathology involving the macula in either eye.<br><br> 6. Subjects who have proliferative or non-proliferative diabetic retinopathy in either<br> eye.<br><br> 7. Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract)<br> in either eye.<br><br> 8. Subjects using any systemic or topical drug known to interfere with visual<br> performance, pupil dilation, or iris structure within 30 days of randomization<br> (refer to the relevant attachment of the Study Reference Manual).<br><br> 9. Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g.,<br> iritis, scleritis, iridocyclitis, or rubeosis iridis) in either eye.<br><br> 10. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or<br> other retinal disorders) that are expected to cause future visual acuity losses to a<br> level of 20/30 or worse in either eye.<br><br> 11. Subjects who have had previous intraocular or corneal surgery in either eye that<br> might confound the outcome of the investigation or increase the risk to the subject<br><br> 12. Subjects with any infectious conjunctivitis, keratitis, or uveitis in either eye.<br><br> 13. Subjects who have irregular astigmatism or skewed radial axis for either eye.<br><br> 14. Subjects who cannot achieve a minimum pharmacologic pupil dilation of at least 5.0<br> mm in both eyes.<br><br> 15. Subjects who may be expected to require a combined or other secondary surgical<br> procedure in either eye (note: corneal incisions intended specifically to reduce<br> astigmatism are not allowed during the study).<br><br> 16. Females of childbearing potential (those who are not surgically sterilized or at<br> least 12 months postmenopausal) are excluded from enrollment in the study if they<br> are currently pregnant or plan to become pregnant during the study, lactating or<br> have a condition associated with fluctuation hormones that could lead to refractive<br> changes. Females of childbearing potential must be willing to practice effective<br> contraception for the duration of their participation in the study.<br><br> 17. Subjects with any other serious ocular pathology or underlying systemic medical<br> disease (e.g., uncontrolled diabetes) or circumstance that, based on the<br> Investigator's judgment, poses a concern for the subjects' safety, increases the<br> operative risk or could confound the results of the study.<br><br> 18. Subjects who have current or previous usage of systemic medications that may<br> confound the outcome or increase the risk to the subject based on the Investigator's<br> judgement. For example; subjects on an alpha-1-selective adrenoceptor blocking agent<br> or an antagonist of alpha 1A adrenoceptor (e.g., tamsulosin hyrdrochloride<br> (Flomax®), Terazosin, Rapaflo or Cardura) or other medications with similar side<br> effects (floppy iris syndrome).<br><br> 19. Subjects who are expected to require retinal laser treatment

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4.;Median Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) of first implanted eyes at Post-Operative Visit 4.;Negative lens induced distance-corrected Depth of focus (D) at 0.20 logMAR of first implanted eyes at Post-Operative Visit 4.;Mean monocular best-corrected distance visual acuity (BCDVA) (logMAR) of first implanted eyes at Post-Operative Visit 4.;Rates with postoperative monocular BCDVA of 20/40 (0.30 logMAR) or better of first implanted eyes at Post-Operative Visit 4.

Secondary Outcome Measures

Name	Time	Method
Mean monocular photopic distance-corrected near visual acuity (DCNVA) of first implanted eyes at Post-Operative Visit 4.