Prospective Clinical Trial to Evaluate the Safety and Effectiveness of the IOL
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 Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment group
|
Device: IOL
Intraocular lens
|
Outcome Measures
Primary Outcome Measures
- Best Corrected Distance Visual Acuity [postoperative days 330-420]
Proportion of subjects achieving BCDVA 0.3 logMAR or better
Eligibility Criteria
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.
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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.
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History of uveitis in either eye.
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History of intraocular or corneal surgery in the study eye.
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Uncontrolled glaucoma in the study eye (per Investigator judgment).
-
Current ocular infection in the study eye.
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Fellow eye BCDVA worse than 1.0 logMAR.
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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.
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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.
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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.)
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Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study.
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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
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Argus Research at Cape Coral Eye Center | Cape Coral | Florida | United States | 33904 |
Sponsors and Collaborators
- Estelle Poineau
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- ONT-301-17
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Treatment Group |
---|---|
Arm/Group Description | IOL: Intraocular lens |
Period Title: Overall Study | |
STARTED | 369 |
COMPLETED | 310 |
NOT COMPLETED | 59 |
Baseline Characteristics
Arm/Group Title | Treatment Group |
---|---|
Arm/Group Description | IOL: Intraocular lens |
Overall Participants | 339 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
69.1
(8.1)
|
Sex: Female, Male (Count of Participants) | |
Female |
208
61.4%
|
Male |
131
38.6%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
18
5.3%
|
Not Hispanic or Latino |
321
94.7%
|
Unknown or Not Reported |
0
0%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
1
0.3%
|
Asian |
9
2.7%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
29
8.6%
|
White |
299
88.2%
|
More than one race |
1
0.3%
|
Unknown or Not Reported |
0
0%
|
Outcome Measures
Title | Best Corrected Distance Visual Acuity |
---|---|
Description | Proportion of subjects achieving BCDVA 0.3 logMAR or better |
Time Frame | postoperative days 330-420 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment Group |
---|---|
Arm/Group Description | IOL: Intraocular lens |
Measure Participants | 310 |
Count of Participants [Participants] |
308
90.9%
|
Adverse Events
Time Frame | 1 year | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Treatment Group | |
Arm/Group Description | IOL: Intraocular lens | |
All Cause Mortality |
||
Treatment Group | ||
Affected / at Risk (%) | # Events | |
Total | 0/339 (0%) | |
Serious Adverse Events |
||
Treatment Group | ||
Affected / at Risk (%) | # Events | |
Total | 13/339 (3.8%) | |
Cardiac disorders | ||
Acute myocardial infraction | 1/339 (0.3%) | 1 |
Aortic aneurysm | 1/339 (0.3%) | 1 |
Eye disorders | ||
Retinal detachment | 1/339 (0.3%) | 1 |
Anterior capsular contraction | 1/339 (0.3%) | 1 |
Gastrointestinal disorders | ||
Gastrointestinal hemorrhage | 1/339 (0.3%) | 1 |
General disorders | ||
Adverse drug reaction | 1/339 (0.3%) | 1 |
Unevaluable event | 1/339 (0.3%) | 1 |
Hepatobiliary disorders | ||
Chronic kidney disease | 1/339 (0.3%) | 1 |
Musculoskeletal and connective tissue disorders | ||
Hip fracture | 1/339 (0.3%) | 1 |
Spinal compression fracture | 1/339 (0.3%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
Malignant neoplasm of unknown primary site | 1/339 (0.3%) | 1 |
Sarcoma metastatic | 1/339 (0.3%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Bronchospasm | 1/339 (0.3%) | 1 |
Pneumonia | 1/339 (0.3%) | 1 |
Pulmonary embolism | 1/339 (0.3%) | 1 |
Surgical and medical procedures | ||
Post procedural complication | 1/339 (0.3%) | 1 |
Post procedural hemorrhage | 1/339 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||
Treatment Group | ||
Affected / at Risk (%) | # Events | |
Total | 32/339 (9.4%) | |
Eye disorders | ||
cystoid macular edema | 7/339 (2.1%) | 7 |
Intraocular pressure increased | 25/339 (7.4%) | 25 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Michael Bonilla |
---|---|
Organization | Carl Zeiss |
Phone | +1 925-557-4100 |
michael.bonilla@zeiss.com |
- ONT-301-17