Evaluating head positioning after retinal detachment repair
Head Positioning Duration After Retinal Detachment Repair With Vitrectomy and Gas
This study is testing if lying face down for just one day after retinal detachment surgery works as well as lying face down for seven days for patients with certain types of retinal breaks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Prairie Village, Kansas) |
| Trial ID | NCT03714503 on ClinicalTrials.gov |
What this trial studies
This study investigates whether one day of prone head positioning after surgery for retinal detachment is as effective as seven days of the same positioning. It focuses on patients with inferior retinal breaks who have undergone pars plana vitrectomy using C3F8 gas as a tamponade. The study employs a single-arm phase II design with a Simon's two-stage approach to assess the anatomical success of the retina at three months and one year post-operatively. A total of 20 patients will be recruited, with the first stage determining if the trial should continue based on initial success rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with primary rhegmatogenous retinal detachment with inferior breaks.
Not a fit: Patients who may not benefit include those with a history of previous retinal detachment repair in the study eye or those with other specific retinal conditions.
Why it matters
Potential benefit: If successful, this study could reduce the duration of required prone positioning after retinal detachment surgery, improving patient comfort and compliance.
How similar studies have performed: While similar studies have explored post-operative positioning, this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Prairie Village, Kansas
- University of Kansas Medical Center — Prairie Village, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Radwan Ajlan, MD — University of Kansas Medical Center
- Study coordinator: Ariana Madrigal
- Email: amadrigal2@kumc.edu
- Phone: 9135880105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.