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ACTIVE NOT RECRUITING
NCT06985030

Head Position Monitoring After Pars Planar Vitrectomy

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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.

Official title: Compliance of Head Positioning After Pars Planar Vitrectomy With Tamponade

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-11-28

Completion Date

2025-06-07

Last Updated

2025-05-22

Healthy Volunteers

No

Interventions

DEVICE

gyroscope embedded eye-sheild

Small pcb with gyroscope and lithium polymer battery embedded eyeshield will be distributed right after surgery

Locations (1)

Seoul National University Hospital, dep. of Ophthalmology

Seoul, South Korea