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

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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 . ]

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Ranibizumab

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.

• Systemc diseases rather than hypertension and diabetes mellitus.

• Corneal opacities that might hinder acquisition of good quality OCT images.