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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05757349
Study type Interventional
Source Tianjin Medical University Eye Hospital
Contact Bojie Hu
Phone 13612130943
Email bhu07@tmu.edu.cn
Status Recruiting
Phase N/A
Start date October 1, 2022
Completion date March 30, 2024

See also
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Completed NCT02895594 - Outcome of Surgery for Idiopathic Macular Holes N/A
Completed NCT00941291 - Outcome of Idiopathic Macular Hole N/A
Completed NCT04683276 - ILM Inverted Flap Size in Macular Hole N/A
Recruiting NCT02905409 - Study of Surgery in Patients With Idiopathic Macular Hole Phase 4
Completed NCT00302328 - Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes N/A
Completed NCT00419185 - Indocyanine Green or Trypan Blue for Delamination of the Internal Limiting Membrane in Macular Hole Surgery N/A