Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371300
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-04-15
Brief Title:
Photobiomodulation With REd vs BluE Light REBEL
Sponsor:
Aston University
Organization:
Aston University
Study Overview
Official Title:
Photobiomodulation of the Ocular Surface and Eyelids With Different Wavelengths REd vs BluE Light REBEL
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The use of photobiomodulation or low-level light therapy LLLT in the ophthalmic field stemmed from dermatology which has shown impact on skin blood flow and regeneration There has been a rise in clinical interest with emerging evidence in the benefits of photobiomodulation in managing chronic inflammatory conditions such as dry eye disease including improvements in ocular discomfort symptoms tear film stability and tear volume Despite the observed clinical benefits limited research has been done to compare photobiomodulation utilising different wavelengths as most research on dry eye disease has focused on red wavelengths It has been purported that blue wavelengths may disrupt microbial growth while red wavelengths stimulate energy production and hence increase heat in the affected tissues although research into these differential impacts at the ocular surface and external eye has been limited Hence the aim of this exploratory clinical trial is to compare the impact of using LLLT incorporating red versus blue wavelengths on eyelid haemodynamics and microbiome as well as conventional ocular surface measures of patients with dry eye disease and blepharitis inflammation of the eyelids
Participants with dry eye disease oil gland disruption and blepharitis will receive 3 treatments with these LLLT each separted by 1 week apart and followed up to 1 month after the final treatment session Participants will be randomised to either of 3 groups Red light only group Red Blue light group or a sham treatment group
Participants with dry eye disease oil gland disruption and blepharitis will receive 3 treatments with these LLLT each separted by 1 week apart and followed up to 1 month after the final treatment session Participants will be randomised to either of 3 groups Red light only group Red Blue light group or a sham treatment group
Detailed Description:
This study will be a randomized double-masked exploratory clinical study to assess the potential difference in impact between the two wavelengths used for LLLT The whole study involves a total of 4 visits consisting of 3 treatment visits and 1 follow-up visit All visits will be conducted at the Aston Dry Eye Clinic in Aston University Birmingham United Kingdom
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None