Effective Prone Time, Idiopathic Macular Hole
Conditions
Brief summary
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.
Interventions
BEHAVIORALFace-down position time 1-day
Postoperative face-down position of subjects wearing the novel positioning sensor device for 1-day.
BEHAVIORALFace-down position time 3-day
Postoperative face-down position of subjects wearing the novel positioning sensor device for 3-day.
Sponsors
Tianjin Medical University Eye Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Macular hole closure rate | 6 month postoperatively | 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 |
| Effective face-down position time | 1 or 3 day postoperatively | Novel positioning sensor related data cloud storage platform can record and extract effective face-down position time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Macular ganglion cell complex thickness change (GCL+, GCL++) | 1, 3, 6 month postoperatively | Three-dimensional spectral domain optical coherence tomography (SD-OCT) |
| Best corrected visual acuity change (BCVA) | 1, 3, 6 month postoperatively | BCVA for patients after macular fissure surgery, expressed using the (ETDRS) Alphabet Chart. |
| Central 2˚ and 4˚ fixation | 1, 3, 6 month postoperatively | Micro Perimeter 3 |
| Mean retinal Sensitivity (MS) | 1, 3, 6 month postoperatively | Micro Perimeter 3 |
| Retinal nerve fiber layer thickness change | 1, 3, 6 month postoperatively | Three-dimensional spectral domain optical coherence tomography (SD-OCT) |
Countries
China
Contacts
Primary ContactBojie Hu
Outcome results
None listed