Description of Study Procedures and Assessments. Detailed descriptions of assessments and procedures are provided in the MOP. The Investigator is responsible for ensuring responsibilities for all procedures and assessments are delegated to appropriately qualified site personnel.
Description of Study Procedures and Assessments. Study-specific procedures and assessments described here may include standard of care; other standard of care procedures performed in the clinical management of the subject are not excluded. Detailed descriptions of assessments and procedures are provided in the MOP. All study procedures and assessments are to be performed according to the table of procedures (Table 3-1). The investigator is responsible for ensuring responsibilities for all procedures and assessments are delegated to appropriately qualified site personnel.
Description of Study Procedures and Assessments. The Investigator is responsible for ensuring responsibilities for all procedures and assessments are delegated to appropriately qualified site personnel.
Description of Study Procedures and Assessments. All study procedures and assessments are to be performed according to the table of procedures (Table 3-1). The investigator is responsible for ensuring responsibilities for all procedures and assessments are delegated to appropriately qualified site personnel.
Description of Study Procedures and Assessments. 10.1.1 Preoperative Examination (Visit 0/0A) ・ Informed consent Routine test conducted for cataract subjects is performed. Subjects still qualifies after these tests are explained this study. Ensure that the subject has read, understood, and signed and dated a statement of informed consent prior to undergoing any study specific testing. Even though routine test was operated before informed consent, these data can be use as study data. ・ Demographics Confirm sex , age and race/ethnicity. ・ Medical history Confirm systemic and ophthalmologic complication, ophthalmologic surgical history. ・ Concomitant medications Indicate the concomitant medications used by the subject at the time of the examination. ・ Urine pregnancy test (female subjects only) Perform a urine pregnancy test if the subject is female and of childbearing potential. ・ Inclusion/exclusion criteria Ensure that the subject meets inclusion/exclusion criteria and meet all qualifications for participation. ・ Visual acuity ・ Manifest refraction Measure using an automated refractometer, and then perform a manifest refraction using the 100% contrast chart at 5m, under photopic lighting condition (100-180 cd/m2). ・ Slit lamp examination Record the presence or absence of clinically significant ophthalmologic findings. ・ Dilated fundus examination Record the presence or absence of clinically significant ophthalmologic findings. ・ Keratometry Keratometry will be performed using an automated keratometer. ・ Target residual refractive error Indicate the amount of postoperative refractive error (±) anticipated based on the power calculation softwareused for the lens power that is chosen. The target for all eyes shall be emmetropia (based on the distance focus power). ・ Calculation by a new Alcon Toric calculator that incorporates ocular trends in Toric IOL planning Calculate the IOL model by a new Alcon Toric calculator that incorporates ocular trends in Toric IOL planning. The formula should be the Xxxxxxxx Total SIA formula. Record the Anticipated Residual Refractive Astigmatism and Indicated IOL Alignment. ・ Topography Corneal topography should be measured and indicate whether the astigmatism is regular or irregular. Irregular astigmatism is an exclusion criterion and these subjects should not be enrolled in the study. ・ Axial length Obtain the axial length by A-mode or IOL master. ・ Anterior chamber depth (ACD) The ACD should be measured from the apex of the cornea to the anterior surface of the natural cr...
Description of Study Procedures and Assessments
