Diabetes Mellitus Clinical Trial
Official title:
The Effect of Intracameral Injection of Dexamethasone After Phacoemulsification in Diabetic Patients on Corneal Endothelial Cell Density
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |