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

NCT05757349 | Unknown

• 1 other identifier: TianjinMUEHhbj456
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Macular Hole; Effective Prone Time

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Best corrected visual acuity change (BCVA)

  1, 3, 6 month postoperatively

• Retinal nerve fiber layer thickness change

  1, 3, 6 month postoperatively

• Macular ganglion cell complex thickness change (GCL+, GCL++)

  1, 3, 6 month postoperatively

• Mean retinal Sensitivity (MS)

  1, 3, 6 month postoperatively

• Central 2˚ and 4˚ fixation

  1, 3, 6 month postoperatively

Study Arms (2)

Face-down position time 1-day group

EXPERIMENTAL

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

Behavioral: Face-down position time 1-day

Face-down position time 3-day group

ACTIVE COMPARATOR

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

Behavioral: Face-down position time 3-day

Interventions

Face-down position time 1-day BEHAVIORAL

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

Face-down position time 1-day group

Face-down position time 3-day BEHAVIORAL

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

Face-down position time 3-day group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Eye Hospital: lead

Study Sites (1)

Tianjin medical university eye hosipital

Tianjin, Tianjin Municipality, China

RECRUITING

Central Study Contacts

Bojie Hu

CONTACT

13612130943; bhu07@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 7, 2023
• Study Start: October 1, 2022
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: March 7, 2023

Record last verified: 2023-02

Locations

CN (1)