Clinical trial NCT03451786: Prospective Clinical Trial to Evaluate the Safety and Effectiveness of the IOL
Official title: A Multi-center, Prospective Clinical Trial to Evaluate the Safety and Effectiveness of a Posterior Chamber Intraocular Lens for Correction of Aphakia Following Cataract Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Unilateral
Aphakia
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2018-03-02
Enrollment: 369
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To establish the safety and effectiveness of the CT LUCIA 611P posterior chamber intraocular lens for the correction of aphakia following extracapsular cataract extraction via phacoemulsification in adult patients.


Eligibility criteria: Inclusion Criteria:

1. Male or female, age 22 years or older at the time of study enrollment.
2. Visually significant cataract in the study eye for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated.
3. Projected postoperative BCDVA 0.20 logMAR or better in the study eye, as determined by Investigator's medical judgment.
4. Calculated spherical power targeted at emmetropia at distance in the study eye.
5. Calculated IOL power between +4.0 D and +34.0 D, inclusive, in the study eye.
6. If wearing rigid gas permeable (RGP) contact lens in the study eye, willingness to discontinue lens wear for ≥ 30 days prior to preoperative biometry.
7. Availability, willingness, and sufficient cognitive awareness to return for study-required visits and comply with examination procedures.
8. Willingness to sign the IRB-approved informed consent form (ICF) for study participation.

Exclusion Criteria:

1. Mature cataract in the study eye that is likely to prolong surgical procedure and/or lead to intraoperative complications prior to attempted IOL implantation.
2. Planned cataract removal using a femtosecond laser.
3. Any visually significant intraocular media opacity other than cataract in the study eye (as determined by the investigator).
4. Significant refractive error (hyperopia/myopia) of axial or pathologic origin in the study eye that, in the judgment of the investigator, could confound outcomes.
5. Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism).
6. Any anterior segment pathology in the study eye that could significantly affect outcomes (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, clinically significant corneal or anterior membrane dystrophies, poor pupil dilation, etc.)
7. Any condition in the study eye that could affect IOL stability (e.g. pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.).
8. History of severe dry eye in the study eye that, in the judgment of the investigator, would impair the ability to obtain reliable study measurements.
9. History of serious corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.) in either eye.
10. History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eye that could alter or limit final postoperative visual prognosis.
11. History of cystoid macular edema in either eye.
12. History of uveitis in either eye.
13. History of intraocular or corneal surgery in the study eye.
14. Uncontrolled glaucoma in the study eye (per Investigator judgment).
15. Current ocular infection in the study eye.
16. Fellow eye BCDVA worse than 1.0 logMAR.
17. Presence of uncontrolled systemic disease that could increase operative risk (e.g., diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.).
18. Use of or history of use of systemic medications with significant ocular side effects or any medications that could confound the outcome or increase patient risk (e.g., steroids, Tamsulosin Hydrochloride \[Flomax\] or other medications including anticholinergics or alpha-adrenergic blocking agents with similar side effects \[e.g. small pupil/floppy iris syndrome\], anti-metabolites, etc.)
19. Participation in any other non-eye related drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation.
20. Participation in any eye-related drug or device clinical trial within 90 days prior to enrolling in this study and/or during the study participation.
21. Planned concomitant ocular procedure during cataract surgery (e.g., glaucoma surgery including implantation of MIGS, astigmatic correction surgery, penetrating keratoplasty \[PK\], laser-assisted in situ keratomileusis \[LASIK\], etc.)
22. Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study.
23. Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).

Primary outcomes:
measure: Best Corrected Distance Visual Acuity
timeFrame: postoperative days 330-420
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Coral
country: United States
facility: Argus Research at Cape Coral Eye Center
state: Florida
Study officials:
References:
citation: Schallhorn SC, Bonilla M, Pantanelli SM. Outcomes of a multicenter U.S. clinical trial of a new monofocal single-piece hydrophobic acrylic IOL. J Cataract Refract Surg. 2022 Oct 1;48(10):1126-1133. doi: 10.1097/j.jcrs.0000000000000943. Epub 2022 Mar 25.