| Trial ID: | L2238 |
| Source ID: | NCT05413330
|
| Associated Drug: |
Triamcinolone Acetonide
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| Title: |
Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.
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| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Diabete Type 2|Cataract|Triamcinolone Acetonide|Intravitreal Injection
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| Interventions: |
DRUG: Triamcinolone Acetonide
|
| Outcome Measures: |
Primary: Change in central subfield mean macular thickness as a measurement of efficacy, The primary endpoint is the change in central subfield mean macular thickness in the 1 mm area (central subfield macular thickness, CSMT) as compared to baseline within the first 6 months postoperatively., T0_ 1 month- T1_ 3 months- T2_ 6 months postoperatively]|Change in diabetic retinopathy grade as a measurement of efficacy, The primary endpoint is the change in diabetic retinopathy grade as compared to baseline within the first 6 months postoperatively., T0: 1 month- T2: 3 months- T3: 6 months postoperatively | Secondary: Change in corrected distance visual acuity CDVA as a measurement of efficacy, CDVA measurements will be taken in metres then converted to Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts (logMAR)., _1 week- T1_ 1 month- T2_ 3 months- T3_ 6 months postoperatively|ntraocular pressure (IOP) as a measurement of safety, IOP (in mmHg) will be measured by Goldmann applanation tonometry, T0: 1 week- T1: 1 month- T2: 3 months- T3: 6 months postoperatively|No. of subjects with Adverse Events as a measurement of safety, An adverse event (AE) is defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the investigational product. All adverse events reported spontaneously by the subject or observed by the principal investigator or his staff will be recorded. Endophthalmitis in particular will be recorded., T0: 1 week- T1: 1 month-T2: 3 months- T3: 6 months postoperatively
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| Sponsor/Collaborators: |
Sponsor: Damascus University
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| Gender: |
ALL
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| Age: |
ADULT
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| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
73
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
|
| Start Date: |
2020-09-12
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| Completion Date: |
2022-03-29
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| Results First Posted: |
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| Last Update Posted: |
2023-04-26
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| Locations: |
Damascus University, Damascus, 00000, Syrian Arab Republic
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| URL: |
https://clinicaltrials.gov/show/NCT05413330
|
