H25
Conditions
Interventions
Group 1: Appropriate patients are included in the study after signing the patient consent form. A total of 10 study visits will be necessary:
Preoperative examination of both eyes, first eye surgery
visual acuities
pupil size (mesopic, photopic, and dilated)
biomicroscopic slit-lamp findings
visual symptoms
biometry (e.g., axial length, ACD, lens thickness, white to white, and IOL power calculation)
ocular dominance
applanation intraocular pressure
dilated fundus exam
potential acuity assessment
subjective questionnaire.
Postoperative visits will assess visual outcomes including: visual acuities
defocus curves
slit-lamp findings
Sponsors
AcuFocus Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Minimum 18 years of age 2. Cataract for which phacoemulsification or femtosecond-assisted extraction and posterior chamber IOL implantation has been planned for each eye 3. Planned procedure in the eye to be implanted with the IC-8 IOL within four to six weeks from the initial procedure of the eye implanted with an aspheric monofocal IOL 4. Best corrected distance visual acuity (CDVA) following cataract removal and IOL implantation projected to be 0.8 (Snellen 20/25) or better as determined by diagnostic testing or investigator’s medical judgment 5. Preoperative anterior chamber depth exclusive of corneal thickness preoperatively of 2.50 to 4.75 mm 6. Clear intraocular media other than cataract 7. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits 8. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Requiring an intraocular lens outside the spherical power range of +16.0 to +27.0 diopters 2. Pharmacologically dilated pupil size less than 6 mm or the presence of any pupil abnormalities (aniridia, non-reactive, fixed, or abnormally shaped pupils) or marked microphthalmos 3. Previous corneal or intraocular surgery, except pterygium surgery that may be allowed based on clinical evaluation 4. Preoperative corneal astigmatism > 1.75 diopters as determined by corneal topography or keratometry in either eye. Or irregular corneal astigmatism 5. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies, or diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study 6. Active or recurrent anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, etc.) 7. Glaucoma suspect, uncontrolled ocular hypertension or glaucomatous changes in the retina or visual field 8. Congenital bilateral cataracts 9. Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration (e.g. pseudoexfoliation, trauma, or posterior capsule defects). 10. Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study (cystoid macular edema, diabetic retinopathy, etc.) 11. Use of systemic or ocular medications that may affect vision, or anti-psychotic and antidepressant medication within the last 6 months 12. Prior, current, or anticipated use during the course of the 6 month study of tamsulosin or silodosin (alpha-adrenergic antagonist medications: e.g., Flomax, Flomaxtra, Rapaflo) likely to cause poor dilation or lack of adequate iris-structure to perform standard cataract surgery 13. Poorly-controlled or insulin dependent diabetes 14. Acute, chronic, or uncontrolled systemic disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, hypertension, etc.) 15. Diagnosis of dry-eye or dependency on ocular lubricating drops to maintain eye comfort or adequate vision 16. Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes 17. Concurrent participation or participation during 30 days prior to preoperative visit in any other or clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| binocular target corrected near visual acuity 3 months post surgery using vision charts | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall satisfaction of the patients 3 months after surgery using Patient questionnaire | — |
Countries
Austria, Belgium, Germany, Italy, Norway, Spain
Contacts
Public ContactH. Burkhard Dick
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH Augenklinik
Outcome results
None listed