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prospective study evaluating the impact of subthreshold micropulsed laser on the number of Aflibercept injections when used as an adjuvant therapy in eyes with diabetic macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | received aflibercept injections alone |
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| Group B | Experimental | received 3 aflibercept injections followed by micropulsed laser |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept Injection | Drug | Group A;Under complete aseptic conditions; intravitreal aflibercept injections with dose of 2 mg/0.05 mL per injection was given for the patients. Patients were scheduled to receive 3 loading injections at monthly interval. At the 3rd month; further treatment was planned pro re nata (PRN) according to the response. Injections were discontinued when the CMT reached 250 µm or less. If there was no change in the CMT after two consecutive injections; patients shifted to other line of treatment. Reinjection was continued for the other eyes with re-evaluation of the response every month.In group B Patients received the initial 3 monthly loading doses of IVI of aflibercept followed by MPL therapy (within one week after the 3rd injection). Patients were scheduled for follow-up monthly. Injection followed by MPL was then repeated according to the response as in group A. |
| Measure | Description | Time Frame |
|---|---|---|
| the number of intravitreal injections | the total number of intravitreal aflibercept injections were recorded | 18th month follow-up. |
| Central macular thickness | in um | 18 month |
| Measure | Description | Time Frame |
|---|---|---|
| best corrected visual acuity measured in ETDRS. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abeer M Khattab, MD | Al Hadi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AlHadi hospital | Hawalli | AlJabryia | 123 | Kuwait |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| micropulsed yellow laser | Other | Micropulse yellow IQ 577nm laser (Iridex Corporation, Mountain View, CA, USA) was employed. The Area Centralis lens (laser spot size magnification 0.94) was utilized with 400 mw power, 200μm spot size and 200 ms pulse duration with 5% duty cycle after micropulse mode activation. Laser was applied on clinically visible thickened macula with different number of confluent non- spacing shots in 7x7 grids. Care was taken to begin treatment outside the foveal avascular zone and not to treat the fovea when there was no visible reaction. If there was any visible reaction; treatment was stopped and the power was reduced until there was no visible reaction. |
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