Device Trial Participant Snapshot: UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE and UNIPEXY Gas Delivery System
Device Category: Ophthalmology
Summary:
What is this device used for?
This intraocular (inside the eye) gas product is used in the UNIFEYE and UNIPEXY Gas Delivery System to treat retinal detachment, which is a separation of the eye’s retina from the eye wall.
How is the device used?
A doctor uses this device during an eye surgery as another option to other substances, such as other gas types, air only, and silicone oil. The gas is an inactive, non-toxic, odorless, and colorless substance that is injected as a gas/air mix or gas/air bubble using the Gas Delivery System.
What are the benefits of this device?
This device offers another option for the treatment of retinal detachment to re-attach the retina.
What are the risks and potential harmful side effects of this device?
Risks with use of this gas device include risks during the surgery and after-surgery risks. These include, but are not limited to, repeated detachment of the retina despite the surgery and increased eye pressure requiring further medical or surgical treatment.
Demographics Snapshot:
Figure 1. Participant Demographics by Sex1
1The pie chart shows only those participants treated with the UNIPURE C3F8 device in the review of all available clinical studies.
Table 1: Participant Demographics2
| Age (years) | Average | Range |
|---|---|---|
| 52.9 | 10-93 | |
| Sex | Number of Participants | Percentage (%) |
| Male | 1,473 | 64.9% |
| Female | 797 | 35.1% |
2The table shows only those participants treated with the UNIPURE C3F8 device in the review of all available clinical studies.
Who participated in the clinical trial studies?
Clinical studies were performed on males and females with uncomplicated retinal detachment between the ages of 10 to 93. Information about the race and ethnicity of the participants was not reported. For more information about the demographics of all participants, please see Table 1.
What did the trials evaluate?
The safety and effectiveness of the C3F8 gas was supported with bench testing and with a review of all available clinical research studies between 1980 and 2022 that investigated the safety and/or effectiveness of this device or equivalent devices. Effectiveness meant the ability to reattach retinas.
Were there any differences in how well the device worked or risks among different sexes, races, ethnicities, and age groups?
While we know the age range and sex of the study patients, we do not have information on whether there were differences in benefits or risks across these groups.
Summary for Clinical Audiences
Supporting data for safety and effectiveness of the C3F8 gas was provided through a systematic literature review of 46 studies of 4,612 patients, 2,270 of whom were treated with this gas. The primary safety endpoint was elevated intraocular pressure (IOP) and primary effectiveness endpoint was retinal re-attachment success rate.