Head Position Monitoring After Pars Planar Vitrectomy

NCT06985030 — Active not recruiting, 100 participants, Seoul National University Hospital

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Compliance of Head Positioning After Pars Planar Vitrectomy With Tamponade

RegistryNCT06985030, acronym HPMPPV
StatusActive not recruiting
Study typeObservational
Enrollment100 (Estimated)
SponsorSeoul National University Hospital (Other)
ConditionsRetinal Detachment, Macular Hole
Interventionsgyroscope embedded eye-sheild (Device)
Datesstart 2024-11-28, primary completion 2025-05-31 (estimated), completion 2025-06-07 (estimated), first posted 2025-05-22, last updated 2025-05-22
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Retinal Detachment All trials for Macular Hole All trials of gyroscope embedded eye-sheild

-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.

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+Arms and interventions

  • gyroscope embedded eye-sheild (Device): Small pcb with gyroscope and lithium polymer battery embedded eyeshield will be distributed right after surgery

+Outcome measures

Primary outcomes

  • Compliance of head positioning [From enrollment to 7 days after surgery]: 1. % time of right head positioning time (%) 2. % time of applying eye patch time (%) 3. Averaged deviation from instructed positioning (degree) 4. % time of cotact between tamponade and retinal tear or macular hole (%) 5. Questionaire (Visual Analogue Scale) : * pain, disability in daily life (dressing, eating, sleeping, washing, households)

Secondary outcomes

  • Baseline demographic and ocular characteristics [At enrollment]: 1. Age (yr) 2. Sex (male/female) 3. Comorbities (if any), (ex. diabetes, hypertension, musculo-skeletal diseases) 4. 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)

+Eligibility

Sex: All

Inclusion Criteria:

* Patients who get vitrectomy

Exclusion Criteria:

* Patients who cannot maintain positioning due to their physical disability

+Locations (1)

FacilityCityCountryStatus
Seoul National University Hospital, dep. of OphthalmologySeoulSouth Korea