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CompletedNCT03451786Updated Apr 11, 2023Results posted

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

An interventional study of IOL in Cataract Unilateral and Aphakia, sponsored by Estelle Poineau. Completed at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-04-11.

Sponsored by Estelle Poineau · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
369
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract Unilateral
  • Aphakia

Browse trials for

03

Who can participate

Ages eligible
22 Years and older
Sexes eligible
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

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).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
369 participants (actual)

Study arms

  • Experimental
    Treatment group

    Device: IOL

Interventions

  • DeviceIOL

    Intraocular lens

05

What researchers measure

Primary outcomes

  1. Best Corrected Distance Visual Acuity

    Proportion of subjects achieving BCDVA 0.3 logMAR or better

    Time frame: postoperative days 330-420

06

Results

Posted Feb 1, 2022

Participant flow

Participant flow — Overall Study
MilestoneTreatment Group
Started369
Completed310
Not completed59

Outcome measures

PrimaryBest Corrected Distance Visual Acuity

Proportion of subjects achieving BCDVA 0.3 logMAR or better

Time frame:
postoperative days 330-420
Reported as:
Count of participants · Participants
Best Corrected Distance Visual Acuity
ParticipantsTreatment Group
Best Corrected Distance Visual Acuity308

Adverse events

Collected over 1 year. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment Group0/339 (0%)13/339 (3.8%)32/339 (9.4%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventTreatment Group
Retinal detachmentEye disorders1/339
Anterior capsular contractionEye disorders1/339
Acute myocardial infractionCardiac disorders1/339
Adverse drug reactionGeneral disorders1/339
Aortic aneurysmCardiac disorders1/339
BronchospasmRespiratory, thoracic and mediastinal disorders1/339
Gastrointestinal hemorrhageGastrointestinal disorders1/339
Hip fractureMusculoskeletal and connective tissue disorders1/339
Malignant neoplasm of unknown primary siteNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/339
PneumoniaRespiratory, thoracic and mediastinal disorders1/339
Most frequent other events
Most frequent other events
EventTreatment Group
Intraocular pressure increasedEye disorders25/339
cystoid macular edemaEye disorders7/339

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment Group
Mean69.1 ± 8.1
Sex: Female, Male
Sex: Female, Male(Participants)Treatment Group
Female208
Male131
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment Group
Hispanic or Latino18
Not Hispanic or Latino321
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment Group
American Indian or Alaska Native1
Asian9
Native Hawaiian or Other Pacific Islander0
Black or African American29
White299
More than one race1
Unknown or Not Reported0
07

Study locations

1 site
  • Argus Research at Cape Coral Eye Center
    Cape Coral, Florida 33904, United States
08

References and documents

Publications

  • 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. PubMed 35333839 ↗

Study documents

  • Study protocol · Dec 21, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03451786
Lead sponsor
Estelle Poineau
Responsible party
Estelle Poineau (Clinical Project Manager, Carl Zeiss Meditec AG) — Sponsor-investigator
First posted
Mar 2, 2018
Start date
Apr 23, 2018
Primary completion
Mar 12, 2020
Completion
Mar 12, 2020
Results posted
Feb 1, 2022
Last update
Apr 11, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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