Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naïve center-involved diabetic macular edema group | Patients with treatment-naïve center-involved diabetic macular edema. |
| |
| Refractory center-involved diabetic macular edema group | Patients with refractory center-involved diabetic macular edema. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micropulse Laser | Other | All laser procedures will be performed in a darkened room. The laser will be delivered together in an 8×8 pattern mode with high density (0µm of spacing) over the entire area of macular edema, including the foveal center and unthickened (200µm) retina with no attempt to target or avoid microaneurysms. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of best-corrected visual acuity | Change of best-corrected visual acuity will be recorded. | 6 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change of central macular thickness | Change of central macular thickness will be recorded. | 6 months post-procedure |
| Change of area thickness | Change of area thickness will be recorded. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
This prospective cohort comparative study was conducted at the Ophthalmology Department of Sohag Teaching Hospital, with approval from the institutional ethical committee.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hossam A Hassan, MD | Contact | 00201026808348 | Dr.hossameabdalfataah@gothi.gov.eg |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the General Authority for Teaching Hospitals and Institutes | Recruiting | Cairo | 11562 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 6 months post-procedure |
| Change of macular volume | Change of macular volume will be recorded. | 6 months post-procedure |