Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-26 @ 1:50 AM
Study NCT ID:
NCT07295704
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema
Sponsor:
The General Authority for Teaching Hospitals and Institutes
Organization:
Study Overview
Official Title:
Comparative Evaluation of Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema
Status:
RECRUITING
Status Verified Date:
2025-12
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:
This study aims to evaluate the effect of subthreshold 577 nm micropulse laser photocoagulation in the treatment of initial and refractory cases of Center-Involved Diabetic Macular Edema.
Detailed Description:
Diabetic Retinopathy (DR) is a common and specific microvascular complication of diabetes that affects 17-54% of people with diabetes aged between 49 and 60 years.
Diabetic macular edema (DME) is one of the most common causes of visual loss in today's society. It affects about 10% of diabetic individuals and 29% of those who have had the condition for more than 20 years.
In micropulse mode, the laser emits short pulses, thereby reducing thermal energy in the target area.
This strategy has two properties: a shorter exposure time and a subvisible clinical endpoint, delivering energy by dividing the beam into a series of short pulses (100-300 µs). Every single pulse has an "on and off" duration (duty cycle (DC)), enabling tissues to cool down before the next pulse.
Diabetic macular edema (DME) is one of the most common causes of visual loss in today's society. It affects about 10% of diabetic individuals and 29% of those who have had the condition for more than 20 years.
In micropulse mode, the laser emits short pulses, thereby reducing thermal energy in the target area.
This strategy has two properties: a shorter exposure time and a subvisible clinical endpoint, delivering energy by dividing the beam into a series of short pulses (100-300 µs). Every single pulse has an "on and off" duration (duty cycle (DC)), enabling tissues to cool down before the next pulse.
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?: