An interventional study of Omega Refractive Capsule with FDA approved Intraocular Lens and FDA approved Intraocular lens in Cataract, sponsored by Omega Ophthalmics. Completed at 1 site in Costa Rica. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-20.
Sponsored by Omega Ophthalmics · Not applicable, Interventional, and Treatment
The objective of this study is to evaluate the safety and effectiveness of the
investigational Omega Refractive Capsule (model V)
This study is a prospective, interventional, randomized, controlled, paired eye, subject-masked design.
Subjects will be randomly assigned to which eye will receive the Omega Refractive capsule V with an FDA approved intraocular lens. Fellow eyes will serve as controls and receive an FDA approved IOL (no Omega capsule).
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 6 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Omega Ophthalmics is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Omega Refractive capsule, model V, with an FDA approved intraocular lens.
Device: Omega Refractive Capsule with FDA approved Intraocular Lens
FDA approved Intraocular Lens
Device: FDA approved Intraocular lens
Omega Refractive Capsule with FDA approved Intraocular Lens
Also known as: FDA approved intraocular lens
FDA approved Intraocular lens
Absence of fusion of peripheral anterior and posterior capsule
slit lamp exam
Time frame: 6 Month Postoperative Visit
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Omega Ophthalmics