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Prospective interventional study on 60 eyes of resistant diabetic macular edema and central retinal vein occlusion that will receive suprachoroidal injection of Triamcinolone Acetonide (SCTA).
Patients fulfilling one or more of the following criteria will be considered to have resistant diabetic macular edema (DME) after at least 3 consecutive monthly anti vascular endothelial growth factor (VEGF) injections in the previous 6 months: central macular thickness greater than 300 μm by spectral-domain optical coherence tomography (SD-OCT), reduction of retinal thickness by less than 10% of baseline retinal thickness, or suboptimal visual improvement (failure to gain at least 3 lines on the Snellen chart).
The subjects included in the research will undergo the following tests and investigations:
Exclusion criteria will be:
Injection technique:
Preoperative preparation:
All patients were dilated before suprachoroidal injection of Triamcinolone Acetonide (SCTA) and indirect ophthalmoscope was placed at hand to examine fundus after injection.
We used 30 gauge 1cc insulin syringe. Other dispensable included 24 gauge intravenous branula. Needle was withdrawn from branula and branula was cut in such a way that only 1000um of insulin syringe was exposed from the edge of branula. 0.1 ml (4 mg ) of Triamcinolone Acetonide (TAAC) will be injected.
Post operative care:
After the injection topical antibiotic drop was applied (Moxifloxacin hydrochloride 0.5% Vigamox, Alcon, USA) and the eye was patched for several hours.
After surgery patients were instructed to administer antibiotic drop four times daily for 3 days .
Privacy of the patients must be guaranteed ,the data acquired from the participants will stay confidential through:
Any unexpected risks like subconjunctival hemorrhage, syncope, vitreous hemorrhage, retinal detachment and endophthalmitis appeared during the course of the research will be cleared to the participants and the ethical committee on time.
Medical care will be carried out to complications like syncope, subconjunctival hemorrhage and surgical treatment by pars plana vitrectomy will be done in case of occurrence of vitreous hemorrhage, retinal detachment or endophthalmitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| resistant diabetic macular edema and central retinal vein occlusion | Experimental |
Cases with recent onset central retinal vein occlusion less than 2 months duration will be included |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1 | Drug | suprachoroidal injection of the drug in cases of resistant diabetic macular edema and central retinal vein occlusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of central macular thickness | Reduction of the central macular thickness below 300 um | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| improved vision | Improvement of best corrected visual acuity | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amin E Nawar, Lecturer | Contact | 00201140095692 | nawar20012002@gmail.com | |
| Esraa A Mohammad, L;ecturer | Contact | 00201201500472 | esraaaziz87@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Amin E Nawar, Lecturer | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | El Gharbia | 31111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40604486 | Derived | Nawar AE. Efficacy of combined topical nepafenac 0.3% with suprachoroidal injection of triamcinolone acetonide using a modified custom needle in pseudopkakic cystoid macular edema. BMC Ophthalmol. 2025 Jul 3;25(1):350. doi: 10.1186/s12886-025-03972-6. | |
| 36438589 | Derived | Nawar AE. Effectiveness of Suprachoroidal Injection of Triamcinolone Acetonide in Resistant Diabetic Macular Edema Using a Modified Microneedle. Clin Ophthalmol. 2022 Nov 21;16:3821-3831. doi: 10.2147/OPTH.S391319. eCollection 2022. |
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cases of resistant diabetic macular edema and central retinal vein occlusion
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code number will be given for each participant
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|
| 35469288 | Derived | Nawar AE. Modified Microneedle for Suprachoroidal Injection of Triamcinolone Acetonide Combined with Intravitreal Injection of Ranibizumab in Branch Retinal Vein Occlusion Patients. Clin Ophthalmol. 2022 Apr 19;16:1139-1151. doi: 10.2147/OPTH.S361636. eCollection 2022. |
| ID | Term |
|---|---|
| D010211 | Papilledema |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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