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Active, Not Recruiting

NCT Number: NCT06985030

Head Position Monitoring After Pars Planar Vitrectomy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital, dep. of Ophthalmology

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who get vitrectomy

Exclusion criteria

  • Patients who cannot maintain positioning due to their physical disability

Treatment and study plan

gyroscope embedded eye-sheild

Device

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

Primary outcomes

  1. Compliance of head positioning

    Time frame: From enrollment to 7 days after surgery

    • % time of right head positioning time (%)
    • % time of applying eye patch time (%)
    • Averaged deviation from instructed positioning (degree)
    • % time of cotact between tamponade and retinal tear or macular hole (%)
    • Questionaire (Visual Analogue Scale) :
    • pain, disability in daily life (dressing, eating, sleeping, washing, households)

Secondary outcomes

  1. Baseline demographic and ocular characteristics

    Time frame: At enrollment

    • Age (yr)
    • Sex (male/female)
    • Comorbities (if any), (ex. diabetes, hypertension, musculo-skeletal diseases)
    • Baseline ocular characteristics
    • Visual acuity (logMAR)
    • Intraocular pressure (mmHg)
    • Wide fundus photo image
    • Optical Coherance Tomography image
    • Axial length (mm) (by ultrasonography A-scan, and IOL master)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Compliance of Head Positioning After Pars Planar Vitrectomy With Tamponade

Acronym: HPMPPV

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 22, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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