H25
Conditions
Interventions
Group 1: Patients who had an IOLMaster measurement of their eye with the traditional IOLMaster software before cataract surgery
Group 2: Patients who had an IOLMaster measurement with the raytracing s
Sponsors
Carl Zeiss Meditec AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. PE2 The mean absolute residual refraction-error related to the cylinder MARE_CYLRT is at maximum 0.25 D higher than the MARE_CYLHAI. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 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. SE3 Calculation and analysis of the mean absolute residual refraction (error) related to the spherical equivalent MARE_SERT SE4 Calculation and analysis of the mean absolute residual refraction(error) related to the cylinder MARE_CYLRT. | — |
Countries
Germany
Contacts
Public ContactRuth Dittmann
Carl Zeiss Meditec AG
Outcome results
None listed