Head Position Monitoring After Pars Planar Vitrectomy

NCT06985030 | Active Not Recruiting DMC

• 1 other identifier: 2404-050-1527
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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)

  From enrollment to 7 days after surgery

Secondary Outcomes (1)

• Baseline demographic and ocular characteristics

  At enrollment

Interventions

gyroscope embedded eye-sheild DEVICE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients who get vitrectomy

You may not qualify if:

• Patients who cannot maintain positioning due to their physical disability

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital, dep. of Ophthalmology

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Retinal Detachment; Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: May 22, 2025
• Study Start: November 28, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 7, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-03

Locations

KR (1)