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.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 369 is above the median of 103 across 52 interventional studies indexed under Aphakia.
Browse Aphakia studies →This is the only study on the registry with Estelle Poineau as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
Plan to share: No
Ran from Apr 2018 to primary completion in Mar 2020, 22 months.
Results were first posted in Feb 2022, 1 year 10 months after primary completion. A results delay was requested in Mar 2021.
Of 32 industry-sponsored interventional studies with no phase under Aphakia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 23. This study's 22 months is above that.
Counting every sponsor, half of 37 studies reached it within 17 months; a quarter within 9 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
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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