A Phase 2/3 interventional study of Triamcinolone Acetonide in Diabete Type 2, Cataract and Triamcinolone Acetonide, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 19 Years to 49 Years. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by Damascus University · Phase 2/3, Interventional, and Prevention
The investigators aim in this study to investigate the effect of intravitreal triamcinolone acetonide injection on the development of macular edema and the progression of diabetic retinopathy. Whether this injection hastens cataract surgery results or not. The investigators will categorize the participants into two groups: the case group who will receive the injection at the end of the surgery, and the control group who will have routine cataract surgery with no extra injections.
Cataract and diabetic retinopathy (DR) represent two of the top five leading causes of global impaired vision and blindness according to the WHO. Higher incidence and faster cataract progression are well-established in diabetic patients, especially those with higher glycated hemoglobin values. Further, it is estimated that up to 20% of all cataract surgery is performed on diabetic patients. The investigators aim in this study to contribute to investigating the efficacy of triamcinolone acetonide injection at the end of phacoemulsification surgery in patients with type 2 diabetes in comparison with the standard phacoemulsification surgery: whether it blunts the initiation as well as the progression of diabetic macular edema and diabetic retinopathy, and improves visual outcomes. Besides, The investigators aim to evaluate the consequences and safety of the injection.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 73 is close to the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Damascus University is the lead sponsor of 206 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
● A history of diabetes mellitus DM type II that is well-confirmed by an endocrinologist.
Exclusion Criteria:
A history of diabetes mellitus DM type I that is well-confirmed by an endocrinologist or no history of DM.
Patients will receive an intravitreal injection of 4 mg/0.1 mL preservative-free triamcinolone acetonide at the end of surgery.
Drug: Triamcinolone Acetonide
Patients will receive no additional treatment to the standard phacoemulsification surgery.
Intravitreal injection of 4 mg/0.1 mL preservative-free triamcinolone acetonide at the end of phacoemulsification surgery will be injected at 3.5 mm inferolateral and posterior to the limbus.
Also known as: Kenalog
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.
Time frame: 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.
Time frame: T0: 1 month- T2: 3 months- T3: 6 months postoperatively
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).
Time frame: _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
Time frame: 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.
Time frame: T0: 1 week- T1: 1 month-T2: 3 months- T3: 6 months postoperatively
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Damascus University