Clinical Trial

Head Position Monitoring After Pars Planar Vitrectomy

Study acronym: HPMPPV
Active, Not Recruiting
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Record status
This record was last updated May 22, 2025 (before its estimated May 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
In ophthalmic surgical practice, particularly for treating retinal detachment and macular hole disorders, vitrectomy procedures are routinely performed to remove the vitreous body followed by the injection of tamponade agents such as gaseous compounds (e.g., C3F8 or SF6) or silicone oil. These tamponade materials function by creating internal pressure against the retinal surface to facilitate reattachment. A critical determinant of surgical success in these cases is postoperative head positioning (prone posturing), as improper alignment may compromise the tamponade effect. At the investigators' institution, participants undergoing such procedures are prescribed a strict prone position regimen for 7 consecutive postoperative days. This facedown positioning protocol aims to optimize interfacial contact between the tamponade agent and retinal tissue. However, conventional clinical practice faces a significant limitation: the inability to objectively verify patient compliance with prescribed postural guidelines outside clinical settings. Subjective patient reporting and intermittent clinical observations prove insufficient for quantifying adherence levels. To address this critical gap in postoperative monitoring, the investigators propose implementing a novel electronic monitoring system integrated into therapeutic eye patches. This advanced device incorporates a miniaturized triaxial gyroscopic sensor array capable of continuously tracking cephalo-cervical orientation with high angular resolution. The system features complete electrical isolation from ocular tissues while maintaining sterility. Data acquisition occurs through a microSD card (capacity: 16GB) that logs positional parameters at 0.2Hz sampling frequency, creating comprehensive temporal records of head movement patterns.
Trial Details
NCT Number NCT06985030
Lead Sponsor Seoul National University Hospital
Conditions Retinal Detachment, Macular Hole
Enrollment 100 participants
Start Date 2024-11-28
Primary Completion 2025-05-31 (estimated)
Study Completion 2025-06-07 (estimated)
Updated on ClinicalTrials.gov 2025-05-22