The purpose of the safety assessment was to gain the first patient feedback on the safety of ptosis crutch as well as aesthetic appearance, comfort and eventually willingness to use the device.
When the safety assessment was being carried, the following factors were considered:
Comfort; what will be its impact on the patients skin? Will it cause any pain?
Ease of attachment; will the device fall off once
attached? Will the attachment be firm enough not be affected by the movement of the eye lid which in the end can cause injury?
Results from the questionnaires showed that the response was indeed positive.
All participants showed willingness to use the ptosis for a very long period of time.
All participants reported that the device deed not cause any skin irritation or pain which make the device safe to use.
All participants reported that the device can not cause any injury.
The device also fits well.