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
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.
Exclusion Criteria:
Device: IOL
Intraocular lens
Best Corrected Distance Visual Acuity
Proportion of subjects achieving BCDVA 0.3 logMAR or better
Time frame: postoperative days 330-420
| Milestone | Treatment Group |
|---|---|
| Started | 369 |
| Completed | 310 |
| Not completed | 59 |
Proportion of subjects achieving BCDVA 0.3 logMAR or better
| Participants | Treatment Group |
|---|---|
| Best Corrected Distance Visual Acuity | 308 |
Collected over 1 year. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group | 0/339 (0%) | 13/339 (3.8%) | 32/339 (9.4%) |
| Event | Treatment Group |
|---|---|
| Retinal detachmentEye disorders | 1/339 |
| Anterior capsular contractionEye disorders | 1/339 |
| Acute myocardial infractionCardiac disorders | 1/339 |
| Adverse drug reactionGeneral disorders | 1/339 |
| Aortic aneurysmCardiac disorders | 1/339 |
| BronchospasmRespiratory, thoracic and mediastinal disorders | 1/339 |
| Gastrointestinal hemorrhageGastrointestinal disorders | 1/339 |
| Hip fractureMusculoskeletal and connective tissue disorders | 1/339 |
| Malignant neoplasm of unknown primary siteNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/339 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/339 |
| Event | Treatment Group |
|---|---|
| Intraocular pressure increasedEye disorders | 25/339 |
| cystoid macular edemaEye disorders | 7/339 |
| Age, Continuous(years) | Treatment Group |
|---|---|
| Mean | 69.1 ± 8.1 |
| Sex: Female, Male(Participants) | Treatment Group |
|---|---|
| Female | 208 |
| Male | 131 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Group |
|---|---|
| Hispanic or Latino | 18 |
| Not Hispanic or Latino | 321 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment Group |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 9 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 29 |
| White | 299 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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