Stability and visual outcomes of the capsulotomy-fixated FEMTIS-IOL after automated femtosecond laser-assisted anterior capsulotomy
- Conditions
- Senile cataract
- Registration Number
- DRKS00023914
- Lead Sponsor
- Teleon Surgical B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 183
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
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.<br><br>Subjective refraction will be assessed using trial lenses and the cross cylinder method preoperatively and postoperative 6-8 weeks, 6 months and 12 months.<br><br>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.