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Intravitreal ranibizumab injection procedure is simple and effective. In management of chronic DME there is no clear anatomical endpoint. Visual stability is the primary aim. Argon focal laser therapy can be the safe second choice. The combined therapy is successful and practical for chronic DME patients.
Settings and Design: Randomized clinical study
Subjects and Methods:
investigators randomly assigned 150 adults (the average age was 59.32 years ±2.79) with chronic diabetic macular edema involving the macular center for repeated ranibizumab injections (group A-75) or focal/direct argon laser after repeated ranibizumab injections (group B-75). The outcomes were the changes in visual acuity letter score and the central subfield thickness (CST) from baseline to one year. visual-acuity Letter score, and CST were analyzed with independent t-test and Mann Whitney-test. General linear model with multivariate analysis was used for visual acuity letter score, and CST in both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| visual acuity letter score | Active Comparator | visual acuity letter score is used to compare between the two groups after interventional procedures |
|
| macular thickness(CST) | Active Comparator | macular thickness(CST)is used to compare between the two groups after interventional procedures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INTRAVITREAL RANIBIZUMAB INJECTION | Procedure | interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution) |
|
| Measure | Description | Time Frame |
|---|---|---|
| visual acuity letter score | The visual acuity letter score at one-year | one-year follow up |
| central subfield thickness (CST) | the mean CST observed at one-year | one-year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| patient compliant-complications | subjective symptoms | one-year follow up |
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Inclusion Criteria:
Exclusion Criteria:
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Data processed and saved in eye center in the college
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| ID | Term |
|---|---|
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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interventional model
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A clinical trial design strategy in which parties involved in the trial, the investigator and participants, do not know which participants have been assigned which interventions. Type of masking include: double-blind masking.
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