An interventional study of Artisan Aphakia Intraocular Lens in Aphakia, sponsored by Ophtec USA. Suspended at 19 sites in 2 countries. Open to participants aged 2 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Ophtec USA · Not applicable, Interventional, and Treatment
The purpose of this study is to determine the safety and effectiveness of the Artisan Aphakia Lens in the treatment of aphakia in children.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's planned enrollment of 300 is above the median of 103 across 52 interventional studies indexed under Aphakia.
Browse Aphakia studies →Ophtec USA is the lead sponsor of 2 studies on the registry; none are open to participants now.
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.
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.
Implantation of an Artisan intraocular lens to correct aphakia in children
Device: Artisan Aphakia Intraocular Lens
Implantation of an intraocular lens
Best corrected distance visual acuity at 12 months postoperative
Determination of the ability of the lens to correct refractive error caused by aphakia
Time frame: 5 years follow up
This study is suspended, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ophtec USA