RecruitingNot ApplicableNCT03714503

Head Positioning After Retina Detachment Repair

Head Positioning Duration After Retinal Detachment Repair With Vitrectomy and Gas


Sponsor

University of Kansas Medical Center

Enrollment

20 participants

Start Date

Apr 8, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria10

  • 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

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Interventions

DEVICERetina re-attachment repair using C3F8 gas tamponade

Assigning a one day post-operative head positioning


Locations(1)

University of Kansas Medical Center

Prairie Village, Kansas, United States

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NCT03714503