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Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID03714503

Head Positioning Duration After Retinal Detachment Repair With Vitrectomy and Gas

Led by University of Kansas Medical Center · Updated on 2026-05-05

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating if one day of post-operative prone head positioning is as effective as seven days in patients with retinal detachments involving inferior retinal breaks after pars plana vitrectomy PPV using perfluoropropane C3F8 gas as a tamponade. This single-arm phase II study uses a Simons two-stage design to assess anatomical retina success rates and determine if shorter head positioning is promising for further research. Participants will receive retina re-attachment repair with C3F8 gas tamponade followed by one day of post-operative prone head positioning. The study will enroll 20 patients in two stages 11 patients in the first stage with early stopping rules based on success rates, and if criteria are met, 9 more patients in the second stage. The goal is to achieve retina attachment success in at least 85 of patients. During the study, participants will be monitored for retina attachment using clinical exams with an indirect ophthalmoscope at 3 months and 1 year post-surgery. Researchers will track anatomical success and safety outcomes throughout the follow-up period. The total participation duration varies based on the two-stage design and follow-up assessments. The University of Kansas Medical Center sponsors this trial.

CONDITIONS

Brief Title

Head Positioning After Retina Detachment Repair

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and willing to sign a written informed consent
  • Diagnosed with primary rhegmatogenous retinal detachment with inferior breaks
  • Age 18 years or older
  • Women of child-bearing potential must have a negative rapid urine pregnancy test before surgery
Not Eligible

You will not qualify if you...

  • Pediatric population
  • Pregnant women
  • Previous retinal detachment repair in the study eye
  • History of scleral buckling in the study eye
  • Retinal detachment caused by trauma
  • Asymptomatic longstanding retinal detachments
  • Non-compliance with post-operative treatment
  • Phakic retinal detachment
  • Exudative retinal detachment
  • Retinoschisis related retinal detachment

Research Team

A

Ariana Madrigal

A

Abby Strickland

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