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The goal of this clinical trial is to to evaluate the changes in retinal microvasculature secondary to intra-ocular pressure changes post intra-vitreal injection in patients with diabetic macular oedema highlighting the effect of prior anterior chamber paracentesis on such changes if present .
The main question[s]it aims to answer are:
•[is there any effect of post intra-vitreal injection IOP spikes on retinal microvasculature?] •[is there any effect of Prior Anterior Chamber Paracentesis?] Participants in group A will be subjected to an identified approved treatment( intra-vitreal injection)& Participants in group B will be subjected to a prior ACP with the intra-vitreal injection . ]
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab without Anterior Chamber Paracentesis. |
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| Group B | Active Comparator | Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intra-vitreal injection of Ranibizumab | Drug | The intravitreal injection will be performed with ranibizumab (0.5 mg/0.05 mL through a 27-gauge needle that will be inserted into the sclera 3.5 mm from the corneal limbus in pseudophakic patients, and 4 mm in phakic patients. |
| Measure | Description | Time Frame |
|---|---|---|
| the acute change in angiographic parameters | OCTA of macula and peripapillary region with documentation of vessel density | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| the acute change in intra-ocular pressure | Goldman applanation tonometry for evaluation of IOP | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Cairo | Cairo Governorate | 11591 | Egypt |
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| anterior chamber paracentesis | Procedure | A 27-gauge needle on a 1-mL syringe will be inserted into the anterior chamber of the eye, and approximately 0.05 mL of aqueous humor will be withdrawn. |
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