Custom Needle Preparation for Suprachoroidal Steroid Injection (One Year Results)

NCT ID: NCT05496530

Last Updated: 2022-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-10

Study Completion Date

2023-08-15

Brief Summary

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Suprachoroidal drug delivery is a recent route for managing various ocular conditions. Safety and long term results are still under investigations.

Detailed Description

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In this study, we aim to analyze the long term results of suprachoroidal injection in treating various retinal diseases to focus on its efficacy, safety and long term ocular effects as ocular hypertension, cataract progression and macular edema resolution.

Conditions

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Diabetic Macular Edema Vogt Koyanagi Harada Disease Retinal Vein Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diabetic macular edema

Cases with diabetic macular edema with central macular thickness more than 300 microns measured by optical coherence tomography.

Group Type ACTIVE_COMPARATOR

Suprachoroidal triamcinolone acetonide injection

Intervention Type DRUG

Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.

Vogt-koyanagi harada

Cases with vogt-koyanagi harada and complicated with exudative retinal detachment confirmed by optical coherence tomography.

Group Type ACTIVE_COMPARATOR

Suprachoroidal triamcinolone acetonide injection

Intervention Type DRUG

Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.

Retinal vein occlusion

Cases with retinal vein occlusion and complicated with macular edema confirmed by optical coherence tomography.

Group Type ACTIVE_COMPARATOR

Suprachoroidal triamcinolone acetonide injection

Intervention Type DRUG

Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.

Interventions

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Suprachoroidal triamcinolone acetonide injection

Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* cases with central macular thickness more than 250 microns measured by optical coherence tomography due to one of the following conditions:
* Diabetic macular edema
* Vogt-koyanagi Harada disease
* Retinal vein occlusion.

Exclusion Criteria

* other causes of increased macular thickness as age related macular degeneration and myopic choroidal new vascularization.
* Cases with confirmed diagnosis of glaucoma.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdelshafy

Lecturer of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed A Tabl

Role: PRINCIPAL_INVESTIGATOR

Benha University

Locations

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Ahmed Abdelshafy Tabl

Banhā, Benha, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed A Tabl

Role: CONTACT

01222328766

Facility Contacts

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Ahmed A Tabl

Role: primary

01222328766

Role: backup

Other Identifiers

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Rc-11-22

Identifier Type: -

Identifier Source: org_study_id

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