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

NCT ID: NCT05757349

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-03-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Face-down position time 1-day group

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

Group Type: EXPERIMENTAL

Face-down position time 1-day

Intervention Type: BEHAVIORAL

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

Face-down position time 3-day group

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

Group Type: ACTIVE_COMPARATOR

Face-down position time 3-day

Intervention Type: BEHAVIORAL

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

Interventions

Face-down position time 1-day

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

Intervention Type: BEHAVIORAL

Face-down position time 3-day

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Eye Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bojie Hu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tianjin medical university eye hosipital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bojie Hu

Role: CONTACT

bhu07@tmu.edu.cn

13612130943

Facility Contacts

Bojie Hu

Role: primary

bhu07@tmu.edu.cn

13612130943

Other Identifiers

TianjinMUEHhbj456

Identifier Type: -

Identifier Source: org_study_id