Head Positioning After Retina Detachment Repair
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 investigato
| Condition(s) | Retina; Detachment, Rhegmatogenous |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 longstanding retinal detachments * non-compliance with post-operative treatment * phakic retinal detachment * exudative retinal detachment * retinoschisis related retinal detachment |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Kansas Medical Center |
| Locations | Prairie Village, Kansas, United States |
| Start date | 2019-04-08 |
| NCT ID | NCT03714503 |
| Official listing | https://clinicaltrials.gov/study/NCT03714503 |