IVI Aflibercept Before and After Phaco in DME.

Al Hadi Hospital

Status: Completed

Conditions: Diabetic Macular Edema

Treatments: Procedure: Phacoemulsification with IVI of aflibercept

Study type: Interventional

Funder types: Other

Identifiers

NCT05731089

IVI and phaco

Details and patient eligibility

About

To study whether or not cataract surgery should be deferred until treating the co-existing diabetic macular edema (DME) using intravitreal (IVI) anti-vascular endothelial growth factor (anti-VEGF).

Full description

A prospective randomized interventional study included diabetic patients with visually significant cataract and DME. Patients were divided into 2 groups. Group A received three pre-operative intravitreal Aflibercept injections with a monthly interval, the third injection was given intra-operatively. Group B received a single intra-operative injection, and two post-operative injections with a monthly interval. follow up for 6 months.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetic patients with visually significant cataract

Exclusion criteria

• previous vitreoretinal surgery
• laser or intravitreal injections 6 months prior to the procedure
• intractable glaucom
• active intra-ocular inflammation
• retinal detachment
• vitreous hemorrhage
• epi-retinal membranes
• any other retinal vascular or neuroretinal disease.
• Patients with eventual cataract surgeries

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

group A

Active Comparator group

Description:

Patients in group A were planned to defer the cataract surgery until receiving two injections of Aflibercept at monthly interval, the third injection was then given intra-operatively.

Treatment:

Procedure: Phacoemulsification with IVI of aflibercept

group B

Active Comparator group

Description:

Patients in group B were planned to undergo cataract surgery first and received the first injection intra-operatively, then received two post-operative injections with a monthly interval.

Treatment:

Procedure: Phacoemulsification with IVI of aflibercept