Clinical trial NCT05757349: Analysis of Novel Positioning Sensor-assisted Postoperative Position Correction and Effective Prone Time Recorded in Patients With Different Prone Times After Macular Hole Surgery
Official title: A Prospective Study on the Prognosis of the Idiopathic Macular Hole With Different Prone Position Times Assisted by Novel Positioning Sensor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Macular Hole
Effective Prone Time
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Macular hole closure rate
timeFrame: 6 month postoperatively
measure: Effective face-down position time
timeFrame: 1 or 3 day postoperatively
Secondary outcomes:
measure: Best corrected visual acuity change (BCVA)
timeFrame: 1, 3, 6 month postoperatively
measure: Retinal nerve fiber layer thickness change
timeFrame: 1, 3, 6 month postoperatively
measure: Macular ganglion cell complex thickness change (GCL+, GCL++)
timeFrame: 1, 3, 6 month postoperatively
measure: Mean retinal Sensitivity (MS)
timeFrame: 1, 3, 6 month postoperatively
measure: Central 2˚ and 4˚ fixation
timeFrame: 1, 3, 6 month postoperatively
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin medical university eye hosipital
state: Tianjin
Study officials:
References: