Effect of Intracameral Dexamethasone After Phacoemulsification in Diabetics on Corneal Endothelial Cell Density (DIABEDEX)
Primary Purpose
Diabetes Mellitus, Corneal Endothelial Cell Loss, Dexamethasone Adverse Reaction
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexamethasone
Saline Solutions, Intraocular
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 40 years old
- Type 1 or Type 2 diabetes duration ≥ 10 years
- Visually significant cataract
Exclusion Criteria:
- Dense central corneal opacities as dense nebulae and stromal dystrophies.
- Pre-operative endothelial cell count less than 1500 cell/mm2
- Fuchs dystrophy
- Associated ocular conditions that could affect endothelial cell count as glaucoma and uveitis
- Previous intraocular surgeries
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dexamethasone group
Non-dexamethasone group
Arm Description
Dexamethasone injected at conclusion of Phacoemulsification
No dexamethasone will be injected at the conclusion of Phacoemulsification
Outcomes
Primary Outcome Measures
Mean change in corneal endothelial cell density before and after phacoemulsification
This will be assessed using specular microscopy
Secondary Outcome Measures
Central corneal thickness
Using specular microscopy
Intraocular inflammation
Assessed clinically 1,7 and 30 days after operation
Intraocular pressure
Assessed clinically 1,7 and 30 days after operation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03361709
Brief Title
Effect of Intracameral Dexamethasone After Phacoemulsification in Diabetics on Corneal Endothelial Cell Density
Acronym
DIABEDEX
Official Title
The Effect of Intracameral Injection of Dexamethasone After Phacoemulsification in Diabetic Patients on Corneal Endothelial Cell Density
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Inability to perform the study at present time.
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
July 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Corneal Endothelial Cell Loss, Dexamethasone Adverse Reaction, Corneal Endothelial Decompensation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone group
Arm Type
Active Comparator
Arm Description
Dexamethasone injected at conclusion of Phacoemulsification
Arm Title
Non-dexamethasone group
Arm Type
Placebo Comparator
Arm Description
No dexamethasone will be injected at the conclusion of Phacoemulsification
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
Dexamethasone will be injected intracamerally at the conclusion of Phacoemulsification
Intervention Type
Drug
Intervention Name(s)
Saline Solutions, Intraocular
Intervention Description
Only saline will be injected intracamerally at conclusion of Phacoemulsification
Primary Outcome Measure Information:
Title
Mean change in corneal endothelial cell density before and after phacoemulsification
Description
This will be assessed using specular microscopy
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Central corneal thickness
Description
Using specular microscopy
Time Frame
1 month
Title
Intraocular inflammation
Description
Assessed clinically 1,7 and 30 days after operation
Time Frame
1 month
Title
Intraocular pressure
Description
Assessed clinically 1,7 and 30 days after operation
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 40 years old
Type 1 or Type 2 diabetes duration ≥ 10 years
Visually significant cataract
Exclusion Criteria:
Dense central corneal opacities as dense nebulae and stromal dystrophies.
Pre-operative endothelial cell count less than 1500 cell/mm2
Fuchs dystrophy
Associated ocular conditions that could affect endothelial cell count as glaucoma and uveitis
Previous intraocular surgeries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A. Dahab, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed A Abdel Azim, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shaimaa A Arfeen, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ayman GA Elnahry, Msc
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Intracameral Dexamethasone After Phacoemulsification in Diabetics on Corneal Endothelial Cell Density
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