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

Sponsor

Al-Azhar University (Other)

Overall Status

Completed

CT.gov ID

NCT05345808

Collaborator

(none)

Enrollment

Location

Arm

12.9

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Vein Occlusion	Drug: Triamcinolone Acetonide	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Feb 20, 2022

Actual Study Completion Date :

Mar 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Drug: Triamcinolone Acetonide Triamcinolone Acetonide formulated with chondroitin sulfate and sodium hyaluronate

Arm

Intervention/Treatment

Other: 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.

Drug: Triamcinolone Acetonide

Triamcinolone Acetonide formulated with chondroitin sulfate and sodium hyaluronate

Outcome Measures

Primary Outcome Measures

Best corrected visual acuity [at the base line]
Measured by snellen chart
Best corrected visual acuity [at 1st month]
Measured by snellen chart
Best corrected visual acuity [at 3rd month]
Measured by snellen chart
Best corrected visual acuity [at 6th month]
Measured by snellen chart
Central macular thickness [at 1st month]
Measured by Optical coherence tomography (OCT)
Central macular thickness [at 3rd month]
Measured by Optical coherence tomography (OCT)
Central macular thickness [at 6th month]
Measured by Optical coherence tomography (OCT)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.