A Phase 4 interventional study of Dexamethasone and Saline Solutions, Intraocular in Diabetes Mellitus, Corneal Endothelial Cell Loss and Dexamethasone Adverse Reaction, sponsored by Cairo University. Withdrawn. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by Cairo University · Phase 4, Interventional, and Treatment
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Among 13 studies testing dexamethasone in Diabetes Mellitus — 1 open to participants now, 1 under way, none of them phase 3. Dexamethasone · Diabetes Mellitus.
Among the 13 studies testing dexamethasone in Diabetes Mellitus, this one is the 11th largest by enrollment, is one of 2 that started in 2018, is one of 5 in phase 4, and was the 10th registered.
8,291 studies on the registry are indexed under Diabetes Mellitus; 1,075 are open to participants now.
Browse Diabetes Mellitus studies →1 of the 13 studies testing dexamethasone in Diabetes Mellitus is open now, in 1 country. Recruiting first, the newest first:
David D'Alessio, M.D. · Sites in United States
Ages 18–60 · Healthy volunteers
By country, each count listing its studies:
Dexamethasone: first FDA approval 1958 (DECADRON), first EMA approval 2010. What it is approved for, and how studies give it, is on its page →
Of the 649 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 197 (30%) stop at 75 or younger; 88 take children under 18; 183 take healthy volunteers.
This study: 40 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 30 across the 13 interventional studies. Of the 8 that completed or were terminated, 3 (38%) have results posted.
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2 of 13 have an industry lead sponsor. The 10 most frequent:
Cairo University is the lead sponsor of 4,941 studies on the registry; 1,457 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
36 studies in Diabetes Mellitus by Cairo University: 7 open now, 9 under way, none of them phase 3. Of 14 finished, 1 (7%) have results posted.
Among the 36 studies in Diabetes Mellitus by Cairo University, this one is the 26th largest by enrollment of the 26 interventional ones that give a count, is one of 3 that started in 2018, is one of 2 in phase 4, and was the 6th registered.
Cairo University’s Diabetes Mellitus studies by the year they started, since 2010.
None of the studies under way reaches primary completion within a year.
Among the 13 studies testing dexamethasone in Diabetes Mellitus, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Cairo University’s 36 in Diabetes Mellitus:
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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.
This is a prospective interventional randomized controlled cohort study to determine the safety and benefit of intracameral dexamethasone injection at the conclusion of phacoemulsification in diabetic patients with cataract.
All patients will undergo full ophthalmological examination including best corrected visual acuity (BCVA), intraocular pressure (IOP), anterior segment examination and fundus examination. History and control of diabetes mellitus will be recorded. Patients ≥ 40 years old with a visually significant cataract, who are known to be diabetic for more than 10 years and are free of exclusion criteria will be included in our study.
In addition to routine pre-operative cataract evaluation and investigations, patients will also undergo non-contact Specular Microscopy (Konan Medical, Inc., Hyogo, Japan) to record the pre-operative corneal endothelial cell density in the central cornea, as well as anterior-segment optical coherence tomography (AS-OCT, Optovue Inc., Fremont, CA, USA) to record pre-operative central corneal thickness (CCT).
Standard phacoemulsification will be performed using the Infiniti machine (Alcon, Fort Worth, Texas, USA) with the stop and chop technique, and 0.2 mg of dexamethasone in 0.05 ml will be injected intracamerally at the conclusion of surgery in half of the study eyes, assigned using a randomization method.
Post-operative examination will include BCVA, IOP measurement and level of anterior segment inflammation on days 1,7 and 30 of follow up. Specular microscopy and AS-OCT will be performed at day 30 of follow up. Ophthalmologist performing examinations and investigations will be masked to whether dexamethasone was injected or not to avoid bias.
The difference in mean corneal endothelial cell density before and after phacoemulsification will be compared between both groups. The difference in CCT, post-operative inflammation and IOP will also be compared between both groups.
All statistical analyses will be done using IBM SPSS v20.0 statistical software (IBM Corporation, NY, USA). Descriptive statistics will be calculated, and the data will be summarized as mean ± SD for numerical data, and as frequencies and percentages for categorical data. When the p-value is \< 0.05 this will be considered as statistically significant.
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Exclusion Criteria:
Dexamethasone injected at conclusion of Phacoemulsification
Drug: Dexamethasone
No dexamethasone will be injected at the conclusion of Phacoemulsification
Drug: Saline Solutions, Intraocular
Dexamethasone will be injected intracamerally at the conclusion of Phacoemulsification
Also known as: Decadron
Only saline will be injected intracamerally at conclusion of Phacoemulsification
Mean change in corneal endothelial cell density before and after phacoemulsification
This will be assessed using specular microscopy
Time frame: 1 month
Central corneal thickness
Using specular microscopy
Time frame: 1 month
Intraocular inflammation
Assessed clinically 1,7 and 30 days after operation
Time frame: 1 month
Intraocular pressure
Assessed clinically 1,7 and 30 days after operation
Time frame: 1 month
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2018; primary completion for Jun 2018, 5 months later.
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This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone