Surgical IIH Treatment Trial

Project: Research project

Description

The site will follow the protocol, recruit and retain subjects, attend investigator meetings and calls, and be available as needed for any and all monitoring, regulatory, and safety issues arising during the study.The site will ensure the following equipment is available as well as trained technicians to operate it.Fundus PhotosFundus Camera: Sites will need a manually operated, mydriatic fundus camera that has the ability to image at 30˚ (or 35˚ in Topcon’s case). Examples of this include Zeiss FF4 and FF450+, Topcon TRC 50x, 50XE, 50IA and 50IX. Additional cameras may be acceptable but sites should contact the PRC for approval. Color Camera Resolution: Sites will need to have a color sensor that is at least 3 megapixels in size. CD-ROM Back-Up: Sites will be required to back up all fundus study mages as outlined in the MOP.Internet/Computer: Sites will need to be able to access Axis to upload their study data as outlined in the MOP.OCTIf using Cirrus:1. Zeiss Cirrus™ HD-OCT instrument.2. PC with internet access to log on to UC Davis SFTP site and transfer OCT data3. USB Drive(s) If using Spectralis:1. Heidelberg Spectralis® HRA+OCT instrument.2. PC with internet access to log on to UC Davis SFTP site and transfer OCT data.3. USB Drive(s)Visual Field1. Access to a Humphrey Field Analyzer II to export the files.2. Jump drive to transfer the data files3. Available PC running Window 7 or higher with internet access
StatusFinished
Effective start/end date7/1/186/30/19

Funding

  • Icahn School of Medicine at Mount Sinai (NOT SPECIFIED)
  • Kennedy Institute - National Eye Clinic (NOT SPECIFIED)

Fingerprint

Internet
Color
CD-ROM
Mydriatics
Research Personnel
Safety
Equipment and Supplies