H25
Conditions
Interventions
Group 1: Comparison of two approved IOLs:
arm 1 - Implantation of Vivinex HOYA IOL
Group 2: Implantation of Acrysof Alcon IOL
Sponsors
HOYA Surgical Optics GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Minimum 18 years of age 2. Bilateral clinically significant cataracts for which phacoemulsification extraction and posterior chamber IOL implantation has been planned 3. By surgeon discretion best corrected distance visual acuity projected to be better than 20/40 (0.5) following cataract removal and IOL implantation 4. Clear intraocular media other than cataract 5. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Requiring an intraocular lens outside the commercially available spherical power range 2.Presence of any pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) which at surgeon’s discretion will likely effect study outcomes 3.Previous corneal or intraocular surgery which at surgeon’s discretion will likely effect study outcomes 4.Present corneal or intraocular pathology including pseudo-exfoliation which at surgeon’s discretion will likely effect study outcomes or may require surgical intervention during the course of the study. 5.Inability to achieve keratometric stability for contact lens wearers 6.Intraoperative complications which at surgeon’s discretion may lead to IOL decentration 7.Use of systemic or ocular medications which at surgeon’s discretion will likely effect study outcomes 8.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, etc.) 9.Patient is pregnant, plans to become pregnant, is breastfeeding or has another condition associated with the fluctuation of hormones that could lead to refractive changes 10.Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of PCO (Posterior Capsular Opacification) (6 postoperative follow-ups, grading of PCO, subjective assessment on the slit lamp) | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary endpoint is evaluation of glistening (subjective assessment of glistening / grading on the slit lamp). Other secondary endpoints include the distance corrected visual acuity (measurement of VA with ETDRS charts) for distance and contrast sensitivity. Key safety endpoints are Adverse Events. | — |
Countries
France, Germany
Contacts
Public ContactNorbert Clemens, MD
HOYA Surgical Optics GmbH
Outcome results
None listed