Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions

NCT ID: NCT05345808

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-03-30

Brief Summary

Retinal vein occlusion (RVO) is considered the second vascular disorder of the retina after diabetic retinopathy. Patients with RVO are at risk of the development of macular edema. Different treatment modalities for macular edema include LASER therapy, antivascular endothelial growth factor (VEGF), and triamcinolone.

Aim To detect the efficacy of formulated Triamcinolone Acetonide(TA) injection in the posterior subtenon space to manage macular edema secondary to non-ischemic RVOs, either central or branch.

Conditions

Retinal Vein Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Formulated Posterior Sub Tenon Triamcinolone

All the eyes received single dose 40 mg of Triamcinolone Acetonide (TA) and VISCOAT which is 20 mg sodium chondroitin sulphate and 15 mg sodium hyaluronate (0.5 ml) through posterior subtenon route using NAGATA subtenon canula.

Group Type: OTHER

Triamcinolone Acetonide

Intervention Type: DRUG

Triamcinolone Acetonide formulated with chondroitin sulfate and sodium hyaluronate

Interventions

Triamcinolone Acetonide

Triamcinolone Acetonide formulated with chondroitin sulfate and sodium hyaluronate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diminution of vision due to macular edema secondary to non-ischemic retinal vein occlusions, either central or branch
• CMT ≥ 250 µ,
• Willing to participate in the study.

Exclusion Criteria

• Unwilling to participate in the study
• Ischemic RVO
• previous laser treatment
• Glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris
• patients with previous anti VEGFs or steroid injections or any eye surgery three months before the inclusion
• Cardiac co-morbidities result in significant hemodynamic changes
• Respiratory diseases need treatment with antibiotics
• Suffering from other chronic diseases as diabetes
• Patient with allergy from triamcinolone acetonide.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Akram Fekry Elgazzar

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Akram Fekry Elgazzar

Damietta, , Egypt

Countries

Egypt

Other Identifiers

PSTA in macular edema

Identifier Type: -

Identifier Source: org_study_id