Head Positioning Duration After Retinal Detachment Repair With Vitrectomy and Gas
University of Kansas Medical Center
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
Description
A. Study Objectives: 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 PPV using C3F8 gas as a tamponade. * Primary outcome: retina anatomical success at 3 months post-operatively * Secondary outcome: retina anatomical success at 1 year post-operatively B. Study Type and Design: Single arm phase II study to assess its effectiveness and warrant interest in further development. A Simon's two-stage design will be used to test the following hypoth…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * pediatric population * pregnant women * a previous retinal detachment repair in the study eye * history of scleral buckling in the study eye * trauma as a cause of the retinal detachment * asymptomatic longs…
Interventions
- DeviceRetina re-attachment repair using C3F8 gas tamponade
Assigning a one day post-operative head positioning
Location
- University of Kansas Medical CenterPrairie Village, Kansas