Prospective Clinical Trial to Evaluate the Safety and Effectiveness of the IOL (NCT03451786) | Clinical Trial Compass
CompletedNot Applicable
Prospective Clinical Trial to Evaluate the Safety and Effectiveness of the IOL
United States369 participantsStarted 2018-04-23
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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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.