RECRUITINGINTERVENTIONAL
A Post-Market Clinical Follow-Up on Safety and Performance of the Ophthalmic Viscoelastic Devices Eyefill SC and Eyefill MB
Safety and Performance of the Ophthalmic Viscoelastic Devices Eyefill SC and Eyefill MB - a Post-Market Clinical Follow-Up
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- Adult subjects scheduled for cataract surgery with im-plantation of a posterior chamber intraocular lens;
- Signed willing to sign a consent form;
- Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DEVICE
Eyefill® S.C.
Used as viscoelastic devices during cataract surgery
DEVICE
Eyefill® M.B.
Used as viscoelastic devices during cataract surgery
Locations (2)
Site 102
Madrid, Spain
Site 103
Zaragoza, Spain