Viewing Study NCT03372759


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Study NCT ID: NCT03372759
Status: COMPLETED
Last Update Posted: 2018-03-05
First Post: 2016-11-08
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Tilt of the Intraocular Lens in Patients Undergoing Combined Phacoemulsification and Vitrectomy With Airtamponade
Sponsor: Vienna Institute for Research in Ocular Surgery
Organization:

Study Overview

Official Title: Tilt of the Intraocular Lens in Patients Undergoing Combined Phacoemulsification and Vitrectomy With Airtamponade
Status: COMPLETED
Status Verified Date: 2018-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of epiretinal membranes. Due to the possibility of vitrectomy induced cataract, in many ophthalmic surgical centers it has become usual to indicate combined phacoemulsification and vitrectomy in case of existing cataract.

Epiretinal membranes (ERM) and pseudomaculaforamen are disorders involving the posterior pole of the eyeball with consecutive vision loss. ERM can be well visualized with spectral domain optical coherence tomography (SD-OCT). Different study groups showed that even intraoperative use of SD-OCT is possible.
Detailed Description: The aim of the study is to document tilt of the intraocular lens in combined phacoemulsification and vitrectomy by photography of purkinjereflexes. During vitrectomy tamonade with air or saline are regarded as equal in substituting the removed vitreous. In case of airtamponade, air will be resolved within several days. As airtamponade induces more anterior movement of the implanted intraocular lens in the superior parts of the lens, tilt can result. Saline doesn´t have any influence on the intraocular lens.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: