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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face-down position time 1-day group | Experimental | Postoperative face-down position of subjects wearing the novel positioning sensor device for 1-day. |
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| Face-down position time 3-day group | Active Comparator | Postoperative face-down position of subjects wearing the novel positioning sensor device for 3-day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Face-down position time 1-day | Behavioral | Postoperative face-down position of subjects wearing the novel positioning sensor device for 1-day. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bojie Hu | Contact | 13612130943 | bhu07@tmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin medical university eye hosipital | Recruiting | Tianjin | Tianjin Municipality | China |
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| Face-down position time 3-day | Behavioral | Postoperative face-down position of subjects wearing the novel positioning sensor device for 3-day. |
|
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 |