Head Positioning Duration After Retinal Detachment Repair With Vitrectomy and Gas
Who is this study for? Adults with retinal detachment
What treatments are being studied? Retina re-attachment repair using C3F8 gas tamponade
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study aims to determine if one day post-operative prone head positioning can be as good as seven days post-operative prone head positioning in patients with retinal detachments with inferior retinal breaks after pars that pars plana vitrectomy (PPV) using perfluoropropane (C3F8) gas as a tamponade. The investigator will conduct a single arm phase II study using a Simon's two-stage design
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Ability to understand and the willingness to sign a written informed consent
• Subjects must be diagnosed with primary rhegmatogenous retinal detachment with inferior breaks
• Subjects must be 18 years and older.
• Women of child-bearing potential must agree to take rapid urine pregnancy test before surgical procedure and have negative result.
Locations
United States
Kansas
University of Kansas Medical Center
RECRUITING
Prairie Village
Contact Information
Primary
Ariana Madrigal
amadrigal2@kumc.edu
9135880105
Backup
Abby Strickland
astrickland2@kumc.edu
913-588-6600
Time Frame
Start Date: 2019-04-08
Estimated Completion Date: 2026-10
Participants
Target number of participants: 20
Treatments
Other: One day post-operative head positioning
patients will be assigned to remain a one-day post operative head positioning following retina re-attachment surgery
Related Therapeutic Areas
Sponsors
Leads: University of Kansas Medical Center