Retinal DetachmentHPMPPVNCT06985030
Head Position Monitoring After Pars Planar Vitrectomy
An observational study of Retinal Detachment and Macular Hole, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Detachment, Macular Hole
- What is being tested?
- gyroscope embedded eye-sheild
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Nov 2024to 7 Jun 2025
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who get vitrectomy with gas or silicone oil tamponade followed by positioning prescription
Who may be able to join
- Patients who get vitrectomy
Who cannot join
- Patients who cannot maintain positioning due to their physical disability
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital, dep. of Ophthalmology
Seoul, 03080
About this study
Official title: Compliance of Head Positioning After Pars Planar Vitrectomy With Tamponade
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
- Being tested
- gyroscope embedded eye-sheild
- Medical subject headings
- Retinal Detachment, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gyroscope embedded eye-sheildDevice
Small pcb with gyroscope and lithium polymer battery embedded eyeshield will be distributed right after surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance of head positioning
- % time of right head positioning time (%)
- % time of applying eye patch time (%)
- Averaged deviation from instructed positioning (degree)
- % time of cotact between tamponade and retinal tear or macular hole (%)
- Questionaire (Visual Analogue Scale) :
- pain, disability in daily life (dressing, eating, sleeping, washing, households)
Measured: From enrollment to 7 days after surgery
Secondary outcomes (1)
Baseline demographic and ocular characteristics
- Age (yr)
- Sex (male/female)
- Comorbities (if any), (ex. diabetes, hypertension, musculo-skeletal diseases)
- 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)
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start28 Nov 2024
- Primary completion31 May 2025 (estimated)
- Study completion7 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985030
- Sponsor's protocol ID
- 2404-050-1527
- Acronym
- HPMPPV
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance of Head Positioning After Pars Planar Vitrectomy With Tamponade
- ClinicalTrials.gov ID
- NCT06985030
- Acronym / sponsor ID
- HPMPPV / 2404-050-1527
- Conditions
- Retinal Detachment, Macular Hole
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 7 Jun 2025 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who get vitrectomy with gas or silicone oil tamponade followed by positioning prescription
Key inclusion criteria (1 listed)
- Patients who get vitrectomy
Key exclusion criteria (1 listed)
- Patients who cannot maintain positioning due to their physical disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gyroscope embedded eye-sheildSmall pcb with gyroscope and lithium polymer battery embedded eyeshield will be distributed right after surgery | Device | – |
Primary outcome
Compliance of head positioning
Time frame: 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)
1 secondary outcome
Baseline demographic and ocular characteristics
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Retinal Detachment
RecruitingPhase 2
Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Recruiting
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Detachment and Macular Hole, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance of head positioning (time frame: From enrollment to 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.