A Post-Market Clinical Follow-Up on Safety and Performance of the Ophthalmic Viscoelastic Devices… (NCT06767917) | Clinical Trial Compass
CompletedNot Applicable
A Post-Market Clinical Follow-Up on Safety and Performance of the Ophthalmic Viscoelastic Devices Eyefill SC and Eyefill MB
Spain148 participantsStarted 2024-11-26
Plain-language summary
Prospective, Non-comparative, Post Market Clinical Follow Up Study to demonstrate safety and performance of Eyefill® S.C. and Eyefill® M.B. as viscoelastic devices for cataract surgery
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Adult subjects scheduled for cataract surgery with im-plantation of a posterior chamber intraocular lens;
* Signed informed consent;
* Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria:
* Known hypersensitivity to sodium hyaluronate;
* Corneal endothelial cell density \<1500 cells/mm2;
* Corneal abnormalities;
* Cataract density of grade 4+;
* Previous intraocular or corneal surgery;
* Chronic or recurrent inflammatory eye diseases (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis);
* Clinically significant, uncontrolled glaucoma with expected negative impact on visual acuity outcomes;
* Ongoing systemic or ocular steroid therapy;
* Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity loss to 20/30 or worse in one or both eyes;
* Active ocular or systemic infection (bacterial, viral, or fungal), including fever
* Subjects who may be expected to require a combined or other secondary surgical procedure
* Females of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 12 months) if they meet one of the following conditions: Pregnant, lactating or unwilling to use effective birth control over the course of the study;
* Concurrent or previous (within 30 days) participation in another drug or device investigation.
What they're measuring
1
Mean change in corneal endothelial cell density between baseline and postoperative visits