NCT05413330

Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.

Combined Phacoemulsification Surgery and Intravitreal Triamcinolone Injection Versus Stand-alone Surgery in Patients With Type 2 Diabetes: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 19 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabete Type 2
• Cataract
• Triamcinolone Acetonide
• Intravitreal Injection

Interventions

Type	Name	Description
DRUG	Triamcinolone Acetonide	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.

Timeline

• Start date: 2020-09-12
• Primary completion: 2022-01-05
• Completion: 2022-03-29
• First posted: 2022-06-10
• Last updated: 2023-04-26

Locations

1 site across 1 country: Syria