Effectiveness of IOL power calculation with Raytracing (Blueray). Multicenter Study.
- Conditions
- H25Senile cataract
- Registration Number
- DRKS00010258
- Lead Sponsor
- Carl Zeiss Meditec AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 158
Male or female 18 years of age and older
- Underwent uneventful cataract surgery or clear lens exchange at minimum 6 weeks before
- Implanted IOL model in the study eye: CT ASPHINA 409M/MP
- Had at least one IOLMaster 700 measurement prior to cataract surgery with all measurement quality indicators (biometry and
keratometry) being not red with following parameters are available
- ACD
- LT
- AL
- Keratometry
- Target refraction for implanted IOL power is known and documentation of IOL-calculation is available
- No further surgeries except cataract surgery, clear lens exchange or refractive corneal surgery have been performed on the study eye
- Cataract surgery performed without complications
- No active corneal changes (scars, injuries, inflammations)
- Clear media (cornea, IOL, anterior chamber depth, vitreous body)
- No history of rigid contact lens wear for at least 2 weeks. Soft contact lenses, if worn, removed at least one day prior to the measurements
- Able and willing to make the required study visit
- Able and willing to provide consent and follow study instructions
- Patients must have read, understood and signed the informed consent
- Corneal astigmatism (measured with i.Profiler) = 0.75D
- Corrected Distance Visual Acuity CDVA = 0.67
• Previous intraocular or corneal surgery in the study eye, including any type of surgery for therapeutic purposes. (except cataract surgery)
• Presence of any corneal or retinal abnormality on slit lamp examination in the study eye (scars, injuries, inflammations)
• Opacified/calcified IOL
• Active ocular infection or inflammation.
• Poor tear film/insufficient corneal reflex
• Physical inability to be positioned at the slit-lamp bio-microscope or study devices (e.g. torticollis, head tremor, etc.)
• Insufficient eyelid opening or eyelashes, which partially conceal alignment or keratometry reflections preventing capture of all measurements.
• Inability to fixate (e.g. due to nystagmus, amblyopia or ocular disease, such as macular degeneration).
• Rigid contact lens wear during past two weeks
• Principal Investigator’s determination that the subject is not suitable due to other medical condition
• Pregnancy and/or
• Patients who did not signed informed consent
• Patients who are participating in another ophthalmological clinical study
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PE1 The mean absolute residual refraction error related to the spherical equivalent MARE_SERT is at maximum 0.175 D higher than the MARE_SEHAI for rotationally symmetric intraocular lenses.<br>PE2 The mean absolute residual refraction-error related to the cylinder MARE_CYLRT is at maximum 0.25 D higher than the MARE_CYLHAI.<br>
- Secondary Outcome Measures
Name Time Method SE1 The mean absolute prediction error for the residual refraction related to the spherical equivalent MAPE_SERT is at maximum 0.19 D higher than the MAPE_SEHAI.<br>SE2 The mean absolute prediction error for the residual refraction related to the cylinder MAPE_CYLRT is at maximum 0.35 D higher than the MAPE_CYLHAI.<br>SE3 Calculation and analysis of the mean absolute residual refraction (error) related to the spherical equivalent MARE_SERT<br>SE4 Calculation and analysis of the mean absolute residual refraction(error) related to the cylinder MARE_CYLRT.<br>