Effectiveness of IOL power calculation with Raytracing (Blueray). Multicenter Study. - IOLM75.10 Blueray

Carl Zeiss Meditec AG0 个研究点目标入组 158 人开始时间: 2016年7月4日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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
•- 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

发起方