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Recruiting NCT03714503

NCT03714503 Head Positioning After Retina Detachment Repair

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Clinical Trial Summary
NCT ID NCT03714503
Status Recruiting
Phase —
Sponsor University of Kansas Medical Center
Condition Retina; Detachment, Rhegmatogenous
Study Type INTERVENTIONAL
Enrollment 20 participants
Start Date 2019-04-08
Primary Completion 2028-12

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Retina re-attachment repair using C3F8 gas tamponade

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 20 participants in total. It began in 2019-04-08 with a primary completion date of 2028-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 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

Contact & Investigator

Central Contact

Ariana Madrigal

✉ amadrigal2@kumc.edu

📞 9135880105

Principal Investigator

Radwan Ajlan, MD

PRINCIPAL INVESTIGATOR

University of Kansas Medical Center

Frequently Asked Questions

Who can join the NCT03714503 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Retina; Detachment, Rhegmatogenous. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT03714503 currently recruiting?

Yes, NCT03714503 is actively recruiting participants. Contact the research team at amadrigal2@kumc.edu for enrollment information.

Where is the NCT03714503 trial being conducted?

This trial is being conducted at Prairie Village, United States.

Who is sponsoring the NCT03714503 clinical trial?

NCT03714503 is sponsored by University of Kansas Medical Center. The principal investigator is Radwan Ajlan, MD at University of Kansas Medical Center. The trial plans to enroll 20 participants.

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