The goal of this clinical trial is to clarify the efficacy of anti-vascular endothelial growth factor (anti-VEGF) drugs combined with subthreshold micropulse laser (SML) therapy on retinal function and anatomical recovery in patients with diabetic macular edema (DME). The main questions it aims to answer are: * To clarify the efficacy of anti-VEGF drugs combined with SML therapy on retinal function and anatomical recovery in DME patients. * To explore the changes in visual acuity and optical coherence tomography angiography (OCTA) parameters before and after the treatment of DME with anti-VEGF drugs combined with SML, and further explore the changes in morphological characteristics of retinal microvessels and the potential treatment mechanism. Participants will randomly be given Intravitreous injection of anti-VEGF drugs or anti-VEGF drugs combined with SML therapy. All participants will be followed up for 6 months after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Intravitreous injection of anti-VEGF drugs
577nm micropulse laser photocoagulation therapy
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGcentral macular thickness (CMT)
CMT
Time frame: up to 6 months
best-corrected visual acuity (BCVA)
BCVA
Time frame: up to 6 months
superficial capillary vessel density (SVD)
The vessel density of the superficial capillary plexus level will be analyzed in the 3×3 mm OCTA scanning mode.
Time frame: up to 6 months
deep capillary vessel density (DVD)
The vessel density of the deep capillary plexus level will be analyzed in the 3×3 mm OCTA scanning mode.
Time frame: up to 6 months
foveal avascular zone (FAZ)
The area of FAZ will be evaluated on 3×3 mm OCTA image.
Time frame: up to 6 months
nonperfusion (NP)
The NP regions in the superficial and deep capillary plexuswere will be evaluated on the 3×3 mm OCTA Image by Image J software. The scores were as follows: 1 for 0\~3 NP regions, 2 for 4\~6 NP regions, and 3 for more than 6 NP regions.
Time frame: up to 6 months
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