Senile cataract
Conditions
Interventions
Group 1: Patients with medically indicated cataract diagnosis, treatable with surgery following Intraocular Lens (IOL) implantation
Sponsors
Teleon Surgical B.V.
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: Patient age between 50 – 90 years, Senile cataract, Expected postoperative corneal astigmatism of = 1.0 D, IOL power between +15 D and +27 D, Written informed patient consent regarding participation in the study and data protection
Exclusion criteria
Exclusion criteria: Strabismus, Previous refractive surgery or glaucoma surgery, Previous keratoplasty, Corneal scars, Ocular disorders – other than cataract – that could potentially cause future acuity losses to a level of 0.5 (decimal) or worse in the study eye, Relevant concomitant ophthalmic diseases (such as pseudoexfoliation, glaucoma, traumatic cataract and other comorbidity that could affect capsule bag stability (e.g. Marfan syndrome), Participation of patient in other clinical trial (former participation is no exclusion criterion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IOL decentration should be evaluated intraoperative via surgical microscope image and postoperative 1-7 days, 6-8 weeks, 6 months and 12 months via slit lamp images. Images will be sent to the University of Heidelberg reading center for review and marking with reference points. For the final evaluation of IOL decentration the marked images will be analyzed by the Department of Applied Mathematics (University of Heidelberg) with an validated C++ software. | — |
Secondary
| Measure | Time frame |
|---|---|
| IOL rotation, tilt and distance between iris and natural lens/ IOL should be evaluated preoperative via Topography based Scheimpflug 2D-image, intraoperative via surgical microscope image and postoperative after 1-7 days, 6-8 weeks, 6 months and 12 months via slit lamp images or Topography based Scheimpflug 2D-image. Images will be sent to the University of Heidelberg reading center for review and marking with reference points. For the final evaluation of IOL decentration the marked images will be analyzed by the Department of Applied Mathematics (University of Heidelberg) with an validated C++ software. Subjective refraction will be assessed using trial lenses and the cross cylinder method preoperatively and postoperative 6-8 weeks, 6 months and 12 months. Best-corrected distance visual acuity acuity will be evaluated with ETDRS charts at a distance of 4 or 5 m preoperatively and postoperative 6-8 weeks, 6 months and 12 months. | — |
Countries
Andorra, Australia, Germany, Spain, United Kingdom
Contacts
Public ContactRamin Khormania
Department of Ophthalmology, University of Heidelberg
Outcome results
None listed