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Head Position Monitoring After Pars Planar Vitrectomy

Compliance of Head Positioning After Pars Planar Vitrectomy With Tamponade

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06985030
Acronym
HPMPPV
Enrollment
100
Registered
2025-05-22
Start date
2024-11-28
Completion date
2025-06-07
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Hole, Retinal Detachment

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.

Interventions

DEVICEgyroscope embedded eye-sheild

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients who get vitrectomy

Exclusion criteria

* Patients who cannot maintain positioning due to their physical disability

Design outcomes

Primary

MeasureTime frameDescription
Compliance of head positioningFrom enrollment to 7 days after surgery1. % 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

MeasureTime frameDescription
Baseline demographic and ocular characteristicsAt enrollment1. 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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026