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

Tianjin Medical University Eye Hospital

Status: Enrolling

Conditions: Effective Prone Time; Idiopathic Macular Hole

Treatments: Behavioral: Face-down position time 3-day; Behavioral: Face-down position time 1-day

Study type: Interventional

Funder types: Other

Identifiers

NCT05757349

TianjinMUEHhbj456

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Face-down position time 1-day group

Experimental group

Description:

Postoperative face-down position of subjects wearing the novel positioning sensor device for 1-day.

Treatment:

Behavioral: Face-down position time 1-day

Face-down position time 3-day group

Active Comparator group

Description:

Postoperative face-down position of subjects wearing the novel positioning sensor device for 3-day.

Treatment:

Behavioral: Face-down position time 3-day