Analysis of Novel Positioning Sensor-assisted Postoperative Position Correction and Effective Prone Time Recorded in Patients With Different Prone Times After Macular Hole Surgery

Study Overview
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Brief Summary
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Idiopathic macular hole (IMH) is a fundus disease without clear etiology, most often seen in healthy women over 50 years of age, and is often associated with ocular manifestations such as loss of central vision and visual distortion. It is often associated with loss of central vision, visual distortion, and other ocular manifestations. It is currently treated by vitrectomy combined with internal limiting membranes (ILM) peeling followed by gas filling. A strict prone position for a certain period of time after surgery has a positive effect on the healing of the macular fissure. The need for a strict prone position after IMH has been demonstrated in previous studies (especially when the IMH diameter is >400 μm). However, due to the anti-human mechanics of the face-down position, patient comfort, sleep quality and quality of life are greatly compromised. Therefore, this study designed a smart head position monitoring device to assist patients in maintaining the correct position and recording the effective position time. The study was conducted to determine the shortest prone position time based on macular fissure closure, to minimize the adverse effects of postoperative position, and to obtain the maximum recovery of visual acuity and visual field.

Official Title
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A Prospective Study on the Prognosis of the Idiopathic Macular Hole With Different Prone Position Times Assisted by Novel Positioning Sensor

Conditions
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Idiopathic Macular Hole, Effective Prone Time

Intervention / Treatment
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* Behavioral: Face-down position time 1-day
* Behavioral: Face-down position time 3-day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years or older； Patients diagnosed with IMH; Patients requiring face-down position after vitrectomy combined with ILM peeling and C3F8(14%) gas filling; Tolerated face-down position after surgery; Agreed to the study protocol. Exclusion Criteria: Myopia greater than or equal to -6.0 D; Eye axis length (AL) greater than 26.0mm; Trauma, macular edema, macular degeneration, and other secondary MH with clear etiology; Previous history of internal eye surgery in the operated eye; Patients with local or systemic other diseases significantly affecting visual function; Those who cannot maintain face-down position after surgery due to systemic factors, etc.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Face-down position time 1-day group<br>Postoperative face-down position of subjects wearing the novel positioning sensor device for 1-day. | Behavioral: Face-down position time 1-day<br>* Postoperative face-down position of subjects wearing the novel positioning sensor device for 1-day.<br>|
| Active Comparator: Face-down position time 3-day group<br>Postoperative face-down position of subjects wearing the novel positioning sensor device for 3-day. | Behavioral: Face-down position time 3-day<br>* Postoperative face-down position of subjects wearing the novel positioning sensor device for 3-day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular hole closure rate | Ratio of patients with postoperative lacunae that remained closed until the end of the follow-up time to the number of patients who reopened during the follow-up time of those who did not close after surgery | 6 month postoperatively | 
| Effective face-down position time | Novel positioning sensor related data cloud storage platform can record and extract effective face-down position time. | 1 or 3 day postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity change (BCVA) | BCVA for patients after macular fissure surgery, expressed using the (ETDRS) Alphabet Chart. | 1, 3, 6 month postoperatively | 
| Retinal nerve fiber layer thickness change | Three-dimensional spectral domain optical coherence tomography (SD-OCT) | 1, 3, 6 month postoperatively | 
| Macular ganglion cell complex thickness change (GCL+, GCL++) | Three-dimensional spectral domain optical coherence tomography (SD-OCT) | 1, 3, 6 month postoperatively | 
| Mean retinal Sensitivity (MS) | Micro Perimeter 3 | 1, 3, 6 month postoperatively | 
| Central 2˚ and 4˚ fixation | Micro Perimeter 3 | 1, 3, 6 month postoperatively |