H25
Conditions
Interventions
Group 1: Sodium hyaluronic acid, 30mg/ml (1.0MDa), during surgery
Group 2: Sodium hyaluronic acid, 30mg/ml (0.8MDa), during surgery
Sponsors
Carl Zeiss Meditec AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult subject; 2. Subject has clear intraocular media excluding the presence of cataract; 3. Subject is scheduled for uncomplicated age-related cataract removal by phacoemulsification and IOL implantation in the capsular bag with sole administration of either investigational or control device as per randomization scheme; 4. Subject is informed of the requirements of the Clinical Investigational Plan and available, able and willing to comply with the visit schedule and planned procedures; 5. Subject has given his/her written informed consent.
Exclusion criteria
Exclusion criteria: The subject’s contralateral eye is already participating in this study; 2. Subject has previously undergone or is scheduled for cataract surgery to the contralateral eye within 14 days of the study eye surgery; 3. Mono-ophthalmic subject (e.g., single eye status, amblyopia, strabism, microphthalmos); 4. Subject has had previous ocular trauma or ocular surgery; 5. Subject is scheduled to undergo other combined intraocular procedures in the study eye during the cataract/IOL implantation surgery or during the course of the investigation; 6. Planned Femtosecond Laser cataract surgery; 7. Subject with medically controlled ocular hypertension (regardless of IOP value) or elevated intraocular pressure at baseline > 24 mmHg, uncontrolled glaucoma, or glaucomatous changes; 8. Subject has a history of chronic, recurrent or acute ocular infection or inflammation; 9. Subject has a corneal abnormality or condition preventing reliable specular microscopy (e.g., significant scarring, stromal, epithelial or endothelial dystrophies, edema, irregularity, keratitis, keratoconjunctivitis, kerato uveitis, keratopathy, keratectasia); 10. Subject has reduced corneal endothelium (e.g., Fuch’s dystrophy) or endothelial cell count (ECC) lower than 2000 cells/mm2 on average preoperatively; 11. Subject has an anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (e.g., iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis, pseudoexfoliation syndrome, synechiae, fibrin, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation); 12. Subject has a pupil abnormality (e.g., non-reactive, fixed pupils, abnormally shaped pupils, aniridia, anisocoria, pathologic miosis); 13. Subject has had previous retinal detachment or is predisposed to postoperative retinal complications requiring treatment; 14. Subject has an acute or chronic illness or uncontrolled disease (systemic, ocular or congenital) that would increase the operative risk or confound the outcome(s) of the investigation (e.g., severe dry eye, rubella, congenital or complicated cataracts, changes of the retina, retinal vessel disease, poorly controlled diabetes associated with any changes of the retina, macular degeneration, cystoid macular edema, immunocompromised or healing-process-compromised subjects, Marfan’s Syndrome, connective tissue disease, clinically significant atopic disease, active cancer treatment, mental illness, dementia); 15. Subjects is using or is expected to use systemic or ocular medications during the course of the study that may confound the outcome of the investigation or increase the risk to the subject according to the Investigator’s opinion, including, but not limited to, anti-metabolites (e.g., Tamsulosin Hydrochloride [Flomax] or silodosin or other medications including anticholinergics or alpha-adrenergic blocking agents with similar side effects [e.g., small pupil/floppy iris syndrome]); 16. Subject is using or is expected to use systemic steroids during the course of the study and/or is a known steroid responder; 17. Subject has an allergy to anesthetics, other peri-/postoperative medications, or the investigational and/or control device; 18. Subject has a known hypersensitivity to Sodium Hyaluronate; 19. Subject may require the use of hyaluronidase during cataract surgery; 20. Investigational or control device is not a suitable device for the subject for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Incidence of IOP observations = 30 mmHg at Follow-up 1 (H8) | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance: - Corneal endothelial cell density - Functionality based on questionnaire Safety: - Intraocular inflammation - Intraocular pressure - Further slit lamp examinations - Adverse events - Device deficiencies | — |
Countries
Austria, Czechia, Germany, Slovakia, Spain
Contacts
Public ContactKatharina Drews
Carl Zeiss Meditec AG
Outcome results
None listed