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
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.
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 →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.
patients who get vitrectomy with gas or silicone oil tamponade followed by positioning prescription
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Exclusion Criteria:
Small pcb with gyroscope and lithium polymer battery embedded eyeshield will be distributed right after surgery
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
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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