Diabetic Macular Edema
Conditions
Brief summary
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 . \]
Interventions
DRUGintra-vitreal injection of Ranibizumab
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.
PROCEDUREanterior chamber paracentesis
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1-mL syringe will be inserted into the anterior chamber of the eye, and approximately 0.05 mL of aqueous humor will be withdrawn.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with diabetes mellitus type II. * Patients with visual acuity \> 0.1, able to fixate and with clear visual media. * Patients with eyes with non ischemic diffuse center involving DME were randomly assigned to receive IVI of ranibizumab either without (group A) or with (group B) ACP.
Exclusion criteria
* Age under 40 years. * Poorly controlled diabetics (HbA1C greater than 9.0%) * Proliferative diabetic retinopathy. * OCT-Angiographic evidence of ischemia (enlarged foveal avascular zone, paramacular areas of capillary nonperfusion) * Neovascular AMD in the study eye. * History of glaucoma. * Tilted disc and optic disc anomalies. * One-eyed patients. * Usage of systemic or topical corticosteroids. * Patients with a history of intraocular surgery other than cataract surgery. * Systemc diseases rather than hypertension and diabetes mellitus. * Corneal opacities that might hinder acquisition of good quality OCT images.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the acute change in angiographic parameters | 1 day | OCTA of macula and peripapillary region with documentation of vessel density |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the acute change in intra-ocular pressure | 1 day | Goldman applanation tonometry for evaluation of IOP |
Countries
Egypt
Outcome results
None listed