An interventional study of Retina re-attachment repair using C3F8 gas tamponade in Retina; Detachment, Rhegmatogenous, sponsored by University of Kansas Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Health services research
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
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.
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 hypotheses: null hypothesis (HO): P\<=0.6 versus alternative hypothesis (HI): p >= 0.85.
C. Sample size, statistical methods, and power calculation
1. The sample size calculations are based on a Simon's two-stage minimax design. The Investigators plan to recruit 20 patients (20 eyes) with one day post-operative head positioning. This trial will run as a single-arm study in two stages. In the first stage, the Investigators will define a futility rate of 60%. Thus, 11 patients will be enrolled in this stage and if seven or less than seven patients are not declared a "success", the Investigators will terminate this trial after the first stage. If eight or more successes are found in the first stage, the Investigators will continue to the second stage where the Investigators will enroll an additional 9 patients taking the total sample size to 20 patients. The treatment will be considered as promising for future research if the results find that 16 or more than 16 of the 20 patients are declared a 'success' (based on the literature review and a retrospective study, a success rate of 85% is chosen). This minimax design has an expected sample size of 14 patients and a probability of early termination (PET) of 70%. An analogous calculation for the Optimal Simon's design gives a total sample size of 28 but with the same expected sample size of 14, and so the Investigators have decided to adopt the minimax design.
University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients will be assigned to remain a one-day post operative head positioning following retina re-attachment surgery
Device: Retina re-attachment repair using C3F8 gas tamponade
Assigning a one day post-operative head positioning
Also known as: pars plana vitrectomy
Retina attachment on clinical exam using the indirect ophthalmoscope
Retina remained attached on indirect ophthalmoscopy exam with scleral depression 360 degrees
Time frame: 3 months
Retina attachment on clinical exam using the indirect ophthalmoscope
Retina remained attached on indirect ophthalmoscopy exam with scleral depression 360 degrees
Time frame: 1 year
Plan to share: No
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