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

Status: Unknown
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Tianjin medical university eye hosipital
RECRUITING
Tianjin
Contact Information
Primary
Bojie Hu
bhu07@tmu.edu.cn
13612130943
Time Frame
Start Date: 2022-10-01
Completion Date: 2024-03-30
Participants
Target number of participants: 86
Treatments
Experimental: Face-down position time 1-day group
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.
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Eye Hospital

This content was sourced from clinicaltrials.gov