Head Positioning After Retina Detachment Repair
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/16/2019 |
| Start Date: | May 1, 2019 |
| End Date: | October 2021 |
| Contact: | Ashley Small, MPH |
| Email: | asmall2@kumc.edu |
| Phone: | 913-588-0105 |
Head Positioning Duration After Retinal Detachment Repair With Vitrectomy and Gas
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
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.
- 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 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.
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 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.
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
We found this trial at
1
site
Prairie Village, Kansas 66208
Principal Investigator: Radwan S Ajlan, MBBCh
Phone: 913-588-0105
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