Prospective Clinical Trial to Evaluate the Safety and Effectiveness of the IOL

Sponsor
Estelle Poineau (Industry)
Overall Status
Completed
CT.gov ID
NCT03451786
Collaborator
(none)
339
Enrollment
1
Location
1
Arm
22.6
Actual Duration (Months)
15
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: IOL
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
339 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 23, 2018
Actual Primary Completion Date :
Mar 12, 2020
Actual Study Completion Date :
Mar 12, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Treatment group

Device: IOL
Intraocular lens

Outcome Measures

Primary Outcome Measures

  1. Best corrected distance visual acuity [postoperative days 330-420]

    Proportion of subjects achieving BCDVA 0.3 logMAR or better

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Argus Research at Cape Coral Eye CenterCape CoralFloridaUnited States33904

Sponsors and Collaborators

  • Estelle Poineau

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Estelle Poineau, Clinical Project Manager, Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier:
NCT03451786
Other Study ID Numbers:
  • ONT-301-17
First Posted:
Mar 2, 2018
Last Update Posted:
Mar 9, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2021