Comparative Study Between Intravitreal Injection of Ranibizumab with and Without Prior Anterior Chamber Paracentesis in Patients with Diabetic Macular Oedema Using Optical Coherence Tomography Angiography [OCT-A]
Overview
- Phase
- Phase 4
- Intervention
- intra-vitreal injection of Ranibizumab
- Conditions
- Diabetic Macular Edema
- Sponsor
- Ain Shams University
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- the acute change in angiographic parameters
- Status
- Completed
- Last Updated
- last year
Overview
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 . ]
Investigators
Amr Sanad
Assistant lecturer of ophthalmology
Ain Shams University
Eligibility Criteria
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.
Arms & Interventions
Group A
Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab without Anterior Chamber Paracentesis.
Intervention: intra-vitreal injection of Ranibizumab
Group B
Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis.
Intervention: intra-vitreal injection of Ranibizumab
Group B
Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis.
Intervention: anterior chamber paracentesis
Outcomes
Primary Outcomes
the acute change in angiographic parameters
Time Frame: 1 day
OCTA of macula and peripapillary region with documentation of vessel density
Secondary Outcomes
- the acute change in intra-ocular pressure(1 day)