H25
Conditions
Interventions
Group 1: toric preloaded HOYA intraocular lens
Preop
Surgery
Postop 1 day
Postop 1 week
Postop 30 days
Postop 6 Months
Examinations: visual acuities, manifest refraction, Contrast acuity, keratometry,
Sponsors
Hoya Medical Singapore PTE. LTD.
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult subjects with a minimum age of 22 years 2. Planned for first eye cataract extraction or natural lens removal with implantation of a toric IOL 3. Corneal astigmatism in at least one eye between 0.7D to 4.5D (1.0D and 6.0D at IOL plane). 4. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits 5. Clear intraocular media other than cataract in the study eye 6. Expected postoperative BCDVA of 0.2 LogMAR or better in the study eye 7. Expected postoperative pharmacologically dilated pupil diameter of 5.5 mm or greater 8. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Requiring an intraocular lens outside the available spherical and cylindrical power range 2. Preoperative previous intraocular and corneal surgery, including corneal refractive surgery, or retinal surgery on the study eyes 3. Traumatic cataract in study eyes 4. Strabismus, Amblyopia or Single Eye status 5. Pupil abnormalities (e.g., non-reactive, fixed pupils, or bnormally shaped pupils) 6. Irregular corneal astigmatism 7. Contact lens wear within 6 months of the preoperative examination for PMMA contact lenses, within 1 month of the preoperative examination for gas permeable lenses, or within 3 weeks of the preoperative examination for extended-wear and daily-wear soft contact lenses in the study eye 8. Presence of corneal pathology affecting topography (e.g. stromal, epithelial or endothelial dystrophy) 9. Acute, chronic, or uncontrolled systemic or ocular disease or illness that would increase the operative risk or confound the outcome of the study (e.g. poorly-controlled diabetes, immunocompromised, connective tissue disease, uncontrolled ocular hypertension, glaucomatous changes in the retina, chronic iritis/uveitis, retinal vessel disease, Sicca syndrome, etc.) or where healing processes are compromised 10. Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects 11. Pregnant, plan to become pregnant, are lactating or have another condition associated with the fluctuation of hormones that could lead to significant refractive changes 12. Concurrent participation in any other clinical trial or if they have participated in any other clinical trial during the last 30 days Intraoperative exclusion criteria: 1. Intraoperative application of parasympatholytica e.g. atropine, tropicamide, etc., for pupil dilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: astigmatism, rotational stability, secondary surgical interventions | — |
Secondary
| Measure | Time frame |
|---|---|
| Ocular/ visual symptoms, complications, adverse events and adverse device effects, spherical equivalent | — |
Countries
France, Germany, Spain
Contacts
Public ContactEckart Bertelmann
Charité - Universitätsmedizin
Outcome results
None listed