Comparative Study Between IVI of Ranibizumab with and Without Prior ACP in Patients with DME Using OCT-A

Ain Shams University102 enrolled

Overview

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 . \]

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

102

Conditions

Diabetic Macular Edema

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

the acute change in angiographic parameters

OCTA of macula and peripapillary region with documentation of vessel density

Time frame: 1 day

Secondary Outcomes

the acute change in intra-ocular pressure

Goldman applanation tonometry for evaluation of IOP