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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-VEGF combined SML therapy group | Experimental | The patients were treated with intravitreal injection of anti-VEGF drugs and SML therapy. |
|
| anti-VEGF single therapy group | Active Comparator | Only intravitreal injection of anti-VEGF drugs was given to patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-VEGF | Drug | Intravitreous injection of anti-VEGF drugs |
|
| Measure | Description | Time Frame |
|---|---|---|
| central macular thickness (CMT) | CMT | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| best-corrected visual acuity (BCVA) | BCVA | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiyong Zhang, MD. PhD. | Contact | 13968059392 | zhangzhiyong@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| subthreshold micropulse laser | Radiation | 577nm micropulse laser photocoagulation therapy |
|
| 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. | up to 6 months |
| foveal avascular zone (FAZ) | The area of FAZ will be evaluated on 3×3 mm OCTA image. | 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. | up to 6 months |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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