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

Not Applicable

Recruiting

• Conditions: Effective Prone Time; Idiopathic Macular Hole
• Interventions: Behavioral: Face-down position time 3-day; Behavioral: Face-down position time 1-day

• Registration Number: NCT05757349
• Lead Sponsor: Tianjin Medical University Eye Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-23
• Last Update Submitted: 2023-02-23
• Study First Posted: 2023-03-07
• Last Update Posted: 2023-03-07
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face-down position time 3-day group	Face-down position time 3-day	Postoperative face-down position of subjects wearing the novel positioning sensor device for 3-day.
Face-down position time 1-day group	Face-down position time 1-day	Postoperative face-down position of subjects wearing the novel positioning sensor device for 1-day.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Tianjin medical university eye hosipital; 🇨🇳 Tianjin, Tianjin, China