Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-30 @ 8:08 AM
Study NCT ID:
NCT01975103
Status:
UNKNOWN
Last Update Posted:
2018-11-14
First Post:
2013-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-damaging Retinal Laser Therapy With PASCAL Laser for Macular Diseases
Sponsor:
Federal University of Rio Grande do Sul
Organization:
Study Overview
Official Title:
Phase 2 Study of Non-damaging Retinal Laser Therapy Using PASCAL Laser With Endpoint Management Software for Macular Diseases
Status:
UNKNOWN
Status Verified Date:
2018-11
Last Known Status:
RECRUITING
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:
EPM
Brief Summary:
This trial seeks to prove the safety and efficacy of photothermal stimulation treatment to diabetic macular edema, chronic central serous retinopathy, macular edema secondary to branch retinal vein occlusion and macular telangiectasia.
Detailed Description:
Sub-visible, non-damaging photothermal stimulation (532nm) exposures of 100 ms in duration resulted in enhanced expression of heat shock proteins in the retina. To test clinical efficacy of sub-visible retinal therapy using ms-range exposures of visible lasers one needs first to establish proper titration methods necessary to assure on one hand the lack of tissue damage, and on the other hand sufficient hyperthermia to elicit cellular response. We used an algorithm based on computational and experimental data to provide parameters that can cause photothermal stimulation to the retinal pigment epithelium without causing collateral damage to photoreceptors or choroid. This method will be used to treat macular diseases such as diabetic macular edema, branch retinal vein occlusion macular edema, chronic central serous retinopathy and macular telangiectasia.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: