Prospective Clinical Trial to Evaluate the Safety and Effectiveness of the IOL
Primary Purpose
Cataract Unilateral, Aphakia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract Unilateral
Eligibility Criteria
Inclusion Criteria:
- Male or female, age 22 years or older at the time of study enrollment.
- Visually significant cataract in the study eye for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated.
- Projected postoperative BCDVA 0.20 logMAR or better in the study eye, as determined by Investigator's medical judgment.
- Calculated spherical power targeted at emmetropia at distance in the study eye.
- Calculated IOL power between +4.0 D and +34.0 D, inclusive, in the study eye.
- If wearing rigid gas permeable (RGP) contact lens in the study eye, willingness to discontinue lens wear for ≥ 30 days prior to preoperative biometry.
- Availability, willingness, and sufficient cognitive awareness to return for study-required visits and comply with examination procedures.
- Willingness to sign the IRB-approved informed consent form (ICF) for study participation.
Exclusion Criteria:
- Mature cataract in the study eye that is likely to prolong surgical procedure and/or lead to intraoperative complications prior to attempted IOL implantation.
- Planned cataract removal using a femtosecond laser.
- Any visually significant intraocular media opacity other than cataract in the study eye (as determined by the investigator).
- Significant refractive error (hyperopia/myopia) of axial or pathologic origin in the study eye that, in the judgment of the investigator, could confound outcomes.
- Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism).
- 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.)
- Any condition in the study eye that could affect IOL stability (e.g. pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.).
- 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.
- History of serious corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.) in either eye.
- 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.
- History of cystoid macular edema in either eye.
- History of uveitis in either eye.
- History of intraocular or corneal surgery in the study eye.
- Uncontrolled glaucoma in the study eye (per Investigator judgment).
- Current ocular infection in the study eye.
- Fellow eye BCDVA worse than 1.0 logMAR.
- 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.).
- 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.)
- 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.
- 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.
- 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.)
- Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study.
- Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).
Sites / Locations
- Argus Research at Cape Coral Eye Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
Outcomes
Primary Outcome Measures
Best Corrected Distance Visual Acuity
Proportion of subjects achieving BCDVA 0.3 logMAR or better
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03451786
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Estelle Poineau
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Unilateral, Aphakia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
369 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
IOL
Intervention Description
Intraocular lens
Primary Outcome Measure Information:
Title
Best Corrected Distance Visual Acuity
Description
Proportion of subjects achieving BCDVA 0.3 logMAR or better
Time Frame
postoperative days 330-420
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, age 22 years or older at the time of study enrollment.
Visually significant cataract in the study eye for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated.
Projected postoperative BCDVA 0.20 logMAR or better in the study eye, as determined by Investigator's medical judgment.
Calculated spherical power targeted at emmetropia at distance in the study eye.
Calculated IOL power between +4.0 D and +34.0 D, inclusive, in the study eye.
If wearing rigid gas permeable (RGP) contact lens in the study eye, willingness to discontinue lens wear for ≥ 30 days prior to preoperative biometry.
Availability, willingness, and sufficient cognitive awareness to return for study-required visits and comply with examination procedures.
Willingness to sign the IRB-approved informed consent form (ICF) for study participation.
Exclusion Criteria:
Mature cataract in the study eye that is likely to prolong surgical procedure and/or lead to intraoperative complications prior to attempted IOL implantation.
Planned cataract removal using a femtosecond laser.
Any visually significant intraocular media opacity other than cataract in the study eye (as determined by the investigator).
Significant refractive error (hyperopia/myopia) of axial or pathologic origin in the study eye that, in the judgment of the investigator, could confound outcomes.
Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism).
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.)
Any condition in the study eye that could affect IOL stability (e.g. pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.).
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.
History of serious corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.) in either eye.
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.
History of cystoid macular edema in either eye.
History of uveitis in either eye.
History of intraocular or corneal surgery in the study eye.
Uncontrolled glaucoma in the study eye (per Investigator judgment).
Current ocular infection in the study eye.
Fellow eye BCDVA worse than 1.0 logMAR.
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.).
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.)
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.
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.
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.)
Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study.
Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).
Facility Information:
Facility Name
Argus Research at Cape Coral Eye Center
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33904
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35333839
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.
Results Reference
derived
Learn more about this trial
Prospective Clinical Trial to Evaluate the Safety and Effectiveness of the IOL
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