Center-Involved Diabetic Macular Edema, Initial, Micropulse Laser, Refractory, Treatment
Conditions
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.
Interventions
OTHERMicropulse Laser
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.
Sponsors
The General Authority for Teaching Hospitals and Institutes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years. * Both sexes. * Patients with type 1 or 2 diabetes mellitus (DM), best-corrected visual acuity (BCVA) of 20/400 or better, and center-involved DME \[defined as a central macular thickness (CMT) of \>250 but \<700µm measured by spectral-domain optical coherence tomography\]. * Patients with any level of non-proliferative diabetic retinopathy or proliferative diabetic retinopathy with adequate panretinal photocoagulation (PRP) and no signs of disease activity determined by fluorescein angiography (FA).
Exclusion criteria
* Monocular eyes. * Chronic renal failure or renal transplant because of diabetic nephropathy. * Glycated hemoglobin (HbA1c) of more than 10%. * Vitreomacular traction syndrome. * Epiretinal membrane. * PRP within 4months before the treatment. * Intraocular surgery within 6months, including cataract or vitreoretinal operation. * Rubeosis iridis. * Severe glaucoma. * High-risk proliferative diabetic retinopathy. * Poor dilation. * Increased foveal avascular zone. * Any condition that could interfere with optical coherence tomography (OCT) measurement or visual acuity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of best-corrected visual acuity | 6 months post-procedure | Change of best-corrected visual acuity will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of central macular thickness | 6 months post-procedure | Change of central macular thickness will be recorded. |
| Change of area thickness | 6 months post-procedure | Change of area thickness will be recorded. |
| Change of macular volume | 6 months post-procedure | Change of macular volume will be recorded. |
Countries
Egypt
Contacts
Primary ContactHossam A Hassan, MD
Outcome results
None listed