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

A Prospective Study on the Prognosis of the Idiopathic Macular Hole With Different Prone Position Times Assisted by Novel Positioning Sensor

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Macular Hole; Effective Prone Time
• Intervention / Treatment: Behavioral: Face-down position time 1-day; Behavioral: Face-down position time 3-day

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin medical university eye hosipital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Face-down position time 1-day group; Postoperative face-down position of subjects wearing the novel positioning sensor device for 1-day.	Behavioral: Face-down position time 1-day; Postoperative face-down position of subjects wearing the novel positioning sensor device for 1-day.
Active Comparator: Face-down position time 3-day group; Postoperative face-down position of subjects wearing the novel positioning sensor device for 3-day.	Behavioral: Face-down position time 3-day; Postoperative face-down position of subjects wearing the novel positioning sensor device for 3-day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): March 30, 2024

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Estimate): March 7, 2023

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: TianjinMUEHhbj456

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No