The rationale for this observational study of a CE-marked lens is to prospectively assess the performance, safety, and patient satisfaction in a group of subjects undergoing cataract surgery with bilateral implantation of the RayOne EMV in a monovision configuration. In order to increase the evidence collected from real-world clinical data we are running a multicentre clinical study in several clinics of the Baviera Ophthalmological Group. Study design: prospective, observational, non-comparative.
Study Type
OBSERVATIONAL
Enrollment
51
Lens exchange with an intraocular lens
Clinica Baviera
Valencia, Spain
Visual acuity
Visual acuity was measured using standard clinical charts
Time frame: One month postoperative
Defocus curve
Defocus curve was measured using standard clinical charts
Time frame: One month postoperative
Patient Satisfaction
Patient satisfaction was measured using the Cataract Assessment Patient Questionnaire 9 Short Form (Catquest 9SF) from 1 to 5, being 1 major difficulties and 5 cannot decide
Time frame: One month postoperative
Safety of the device
Safety of the device was measured in terms of the frequency of adverse events related to the device
Time frame: Surgery, first follow-up visit (1-month) and second follow-up visit (6-months)
Quality of vision
Quality of vision was measured using a self-administered questionnaire developed at Clinica Baviera to assess patient satisfaction regarding night vision, from 1 to 4 being 1 the maximun score and 4 the worst score
Time frame: One month postoperative
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