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DIABEDEX
The Effect of Intracameral Injection of Dexamethasone After Phacoemulsification in Diabetic Patients on Corneal Endothelial Cell Density
Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
January 1, 2018
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Primary Completion
June 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The prevalence of diabetes mellitus (DM) is rapidly growing worldwide. One major concern with diabetes mellitus is how it may affect vision in different ways; including the increased risk of developing cataract. Several studies have found an association between diabetes mellitus and the development of cataract. In patients with DM, cataract progression is also faster and occurs at a younger age.5 While results for modern cataract surgery are satisfactory, cataract surgery in diabetic patients carries a higher risk of peri and post-operative complications than in non-diabetic patients. Several studies have shown that the corneal endothelial count of diabetic patients is decreased, with more damage occurring to corneal endothelial cells following phacoemulsification in diabetics than in non-diabetics. This is presumed to be due to increased vulnerability of corneal endothelial cells in diabetics and a delay in the repair process. Administration of topical corticosteroids is the main method to control post-operative inflammation after phacoemulsification, however many studies have also proved the safety and efficacy of intracameral corticosteroids to control inflammation post-operatively. While intracameral triamcinolone is effective in controlling post-operative inflammation, elevation of intraocular pressure is a main concern. Dexamethasone has been found to be effective in controlling post-operative inflammation with no effect on intraocular pressure. This may be due to its rapid turnover and short half-life. No studies however have been performed to evaluate the safety and benefit of intracameral injection of dexamethasone following phacoemulsification in diabetic patients. In the present study, investigators aim to evaluate this and determine its effect on the post-operative corneal endothelial cell density and corneal thickness.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2018
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 29, 2017
Actual (reported)December 5, 2017
Actual (reported)January 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2018
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July 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Mean change in corneal endothelial cell density before and after phacoemulsification
This will be assessed using specular microscopy
1 month
Central corneal thickness
1 month
Intraocular inflammation
1 month
Intraocular pressure
1 month
Dexamethasone injected at conclusion of Phacoemulsification
No dexamethasone will be injected at the conclusion of Phacoemulsification
Dexamethasone will be injected intracamerally at the conclusion of Phacoemulsification
Only saline will be injected intracamerally at conclusion of Phacoemulsification
Ahmed A. Dahab, MD
Cairo University
Ahmed A Abdel Azim, MD
Cairo University
Shaimaa A Arfeen, MD
Cairo University
Ayman GA Elnahry, Msc
Cairo University
0 participants (actual enrollment reported by the registry).
First Submitted
November 29, 2017
First Posted
December 5, 2017
Study Start
January 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Primary Completion
June 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 24, 2019
Record last verified: 2019-07
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Source: ClinicalTrials.gov.
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