Effect of Corona Virus on Intravitreal Injections

Sponsor

Benha University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05494775

Collaborator

(none)

250

Enrollment

Location

Arms

53.9

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

During pandemic of corona virus, patients compliance may be affected. We aim to study the factors lead to unregulated visits and its implications on the final visual outcome.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema Age-Related Macular Degeneration Choroidal Neovascularization Myopic Choroidal Neovascularisation Diabetic Retinopathy	Drug: Anti-vascular endothelial growth factors (Anti-VEGFs)	N/A

Detailed Description

The corona virus pandemic may affects patients regular visits to ophthalmic clinic, we aim to study the sequel of the pandemic on intravitreal injections results in diabetic macular edema, wet age related macular degenerations, myopic choroidal new vascularization, and proliferative diabetic retinopathy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Corona Virus Pandemic on Intravitreal Injections

Actual Study Start Date :

Feb 1, 2019

Anticipated Primary Completion Date :

Jun 11, 2023

Anticipated Study Completion Date :

Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Diabetic macular edema Cases with diabetic macular edema that are prepared for intravitreal injection of anti-vascular endothelial growth factors.	Drug: Anti-vascular endothelial growth factors (Anti-VEGFs) Intravitreal injection of anti-vascular endothelial growth factors (Anti-VEGFs).
Active Comparator: Wet age related macular edema Cases with wet age related macular degenerations that are prepared for intravitreal injection of anti-vascular endothelial growth factors.	Drug: Anti-vascular endothelial growth factors (Anti-VEGFs) Intravitreal injection of anti-vascular endothelial growth factors (Anti-VEGFs).
Active Comparator: Retinal vein occlusion Cases with macular edema secondary to retinal vein occlusion that are prepared for intravitreal injection of anti-vascular endothelial growth factors.	Drug: Anti-vascular endothelial growth factors (Anti-VEGFs) Intravitreal injection of anti-vascular endothelial growth factors (Anti-VEGFs).
Active Comparator: Myopic choroidal new vascularization Cases with myopic choroidal new vascularization that are prepared for intravitreal injection of anti-vascular endothelial growth factors.	Drug: Anti-vascular endothelial growth factors (Anti-VEGFs) Intravitreal injection of anti-vascular endothelial growth factors (Anti-VEGFs).

Outcome Measures

Primary Outcome Measures

Visual acuity [Baseline and monthly after injection till one year of follow-up]
Assessing the changes in best corrected visual acuity in logMAR unit measured by snellen chart.

Secondary Outcome Measures

Central subfield thickness [Baseline and monthly after injection till one year of follow-up]
Assessing the changes in central macular thickness in microns measured by optical coherence tomography

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with the following conditions (diabetic macular edema, wet age related macular degeneration, myopic choroidal new vascularization and retinal vein occlusion complicated with macular edema).