This is a prospective, single center, non-comparative, 90-day follow-up, post-market clinical investigation of etacoat in patients undergoing cataract surgery. The performance is evaluated by the preservation of endothelial cells measured by specular microscopy at the follow-up visit in comparison to baseline values.
Study Type
OBSERVATIONAL
Enrollment
40
Etacoat is a HPMC formulation intended to be used in ophthalmic anterior segment cataract surgery.
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
Vienna, Austria
Specular microscopy to measure the preservation of endothelium
Time frame: 90 days post surgery compared to baseline
Specular microscopy to measure the corneal thickness
Time frame: post surgery, 1 day and 90 days post surgery compared to baseline
Intraocular pressure measurement
Time frame: post surgery, 1 day and 90 days post surgery compared to baseline
Questionnaire to assess the satisfaction with the application
Questionnaire contains the subjective evaluation by the investigator of the IMD's rheological properties as well as the maintenance of the patient's anterior chamber and dome. Scale for the chamber and dome maintenance ranges from flat (worst case) to full chamber (best case) maintained. Scale for rheological properties ranges from dispersive (best case) to cohesive (worst case).
Time frame: day 0
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