Head Position Monitoring After Pars Planar Vitrectomy

NCT ID: NCT06985030

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-28
• Study Completion Date: 2025-06-07

Brief 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.

Conditions

Retinal Detachment; Macular Hole

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

gyroscope embedded eye-sheild

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients who get vitrectomy

Exclusion Criteria

• Patients who cannot maintain positioning due to their physical disability

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital, dep. of Ophthalmology

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2404-050-1527

Identifier Type: -

Identifier Source: org_study_id