An observational study in Presbyopia, sponsored by AcuFocus, Inc.. Not yet recruiting. Open to participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-18.
Sponsored by AcuFocus, Inc. (part of Bausch Health Companies Inc.) · Observational
KAMRA inlay, to be unilaterally implanted into the cornea of a subject's non-dominant eye. The inlay is to be inserted into a stromal pocket created with a surgical femtosecond laser.
This is a post-approval study of the KAMRA inlay performance and potential device-related issues in a broader population over an extended period of time after pre-market establishment of reasonable safety and effectiveness.
Study objectives include:
In addition, the data from a subset of the first 105 subjects who have been enrolled in this study will be used to validate the KAMRA Inlay Patient Questionnaire (KIPQ) for the assessment of patients who have received the KAMRA inlay for the treatment of presbyopia.
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's planned enrollment of 529 is above the median of 88 across 52 observational studies indexed under Presbyopia.
Browse Presbyopia studies →AcuFocus, Inc. is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
First submitted before AcuFocus, Inc. became part of Bausch Health Companies Inc..
Counted across the registry records on this site, refreshed daily.
Phakic, presbyopic patients between the ages of 45 and 60 years old who have cycloplegic refractive spherical equivalent of +0.50 diopters to -0.75 diopters with less than or equal to 0.75 diopters of refractive cylinder, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1.00 to +2.50 diopters of reading add.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Unilateral implantation of the KAMRA inlay in the corneal stroma.
Monocular Near Visual Acuity
Percentage of implanted eyes with monocular near visual acuity of 20/40 or better is greater than or equal to 75% of implanted eyes.
Time frame: Five years
Best-corrected distance visual acuity
Percentage of implanted eyes with a persistent loss of two or more lines of best-corrected distance visual acuity from baseline at the subject's last study visit is less than 5%.
Time frame: Five years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2018; primary completion for Jan 2026, 90 months later.
Of 35 observational studies under Presbyopia, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's planned 90 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.