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Active, not recruitingNCT06985030HPMPPVUpdated May 22, 2025

Head Position Monitoring After Pars Planar Vitrectomy

An observational study in Retinal Detachment and Macular Hole, sponsored by Seoul National University Hospital. Active, not recruiting at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Seoul National University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study 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.

02

Conditions studied

  • Retinal Detachment
  • Macular Hole
03

In context

Retinal Detachment

199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 58 observational studies indexed under Retinal Detachment.

Browse Retinal Detachment studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients who get vitrectomy with gas or silicone oil tamponade followed by positioning prescription

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who get vitrectomy

Exclusion criteria

Exclusion Criteria:

  • Patients who cannot maintain positioning due to their physical disability
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
10 Days
Patient registry
Yes

Interventions

  • Devicegyroscope embedded eye-sheild

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

06

What researchers measure

Primary outcomes

  1. Compliance of head positioning

    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)

    Time frame: From enrollment to 7 days after surgery

Secondary outcomes

  1. Baseline demographic and ocular characteristics

    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)

    Time frame: At enrollment

07

Study locations

1 site
  • Seoul National University Hospital, dep. of Ophthalmology
    Seoul, 03080, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06985030
Responsible party
Sponsor
First posted
May 22, 2025
Start date
Nov 28, 2024
Primary completion
May 31, 2025 (estimated)
Completion
Jun 7, 2025 (estimated)
Last update
May 22, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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