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Intracameral Dexamethasone After Phacoemulsification in Diabetic Patients
NCT03361709Phase 4
Key facts
- Status
- Withdrawn
- Start
- Jan 2018
- Primary completion
- Jun 2018
- Sponsor
- Cairo University
- Modality
- Orthosteric Ligands
- Drugs
- dexamethasone
- Conditions
- corneal endothelial cell losscorneal endothelial decompensation
01
Overview
Phase 4, randomised, single-blind trial of dexamethasone in corneal endothelial cell loss and corneal endothelial decompensation (2 arms), sponsored by Cairo University. Primary endpoint: Mean change in corneal endothelial cell density before and after phacoemulsification at 1 month. Planned start Jan 2018; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Dexamethasone group
Dexamethasone injected at conclusion of Phacoemulsification
Non-dexamethasone group
No dexamethasone will be injected at the conclusion of Phacoemulsification (Saline injected)
03
Who it enrols
Patients aged 40 and older with visually significant cataract and a history of Type 1 or Type 2 diabetes for at least 10 years. Excludes patients with dense central corneal opacities, pre-operative endothelial cell count < 1500 cells/mm2, Fuchs dystrophy, glaucoma, uveitis, or previous intraocular surgeries.
04
Endpoints
Primary
Mean change in corneal endothelial cell density before and after phacoemulsification
Secondary
Central corneal thickness
Intraocular inflammation
Intraocular pressure
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