An interventional study of Alcon Fluid Accommodating Intraocular Lens and Top Con Autorefractor in Aphakia and Presbyopia, sponsored by Alcon Research. Completed at 2 sites in 2 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Other
The purpose of this clinical study is to assess the repeatability of objective refraction using auto refraction on subjects bilaterally implanted (implanted in both eyes) with the Fluid Accommodating IOL (FAIOL).
Subjects will be expected to attend 10 office visits from screening to exit. The total expected duration of participation for each subject in this study is approximately 12 months. The second eye surgery will take place within 7-15 days from the date of the first implanted eye. The primary endpoint will be collected at Month 1, following the 2nd eye implant date.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 99 is close to the median of 103 across 52 interventional studies indexed under Aphakia.
Browse Aphakia studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
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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:
Women of , defined as all women who are physiologically capable of becoming pregnant and who are not for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply:
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implantation of FAIOL in the capsular bag in the posterior chamber of the eye. The IOL is intended to be used over the lifetime of the subject.
Device: Alcon Fluid Accommodating Intraocular Lens · Other: Top Con Autorefractor
Intraocular lens intended to treat presbyopia by dynamically adjusting power, resulting in a continuous range of vision from distance to near.
Also known as: FAIOL, FluidVision MX Accommodating IOL
Device intended to automatically determine the focusing characteristics of the eye
Repeatability of objective refraction
Two assessments of objective refraction (sphere, cylinder, and spherical equivalent) using auto refraction will be made on the same day. Repeatability of objective refraction will be evaluated using the Intra-class correlation coefficient (ICC), separately by eye. ICC is evaluated as the proportion of all variation that is not due to measurement error. Higher values of ICC indicate lower error variance and hence better repeatability. Repeatability of objective refraction will be assessed with and without cycloplegia (temporary paralysis of the ciliary muscle).
Time frame: Month 1 (post 2nd eye implant)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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