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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Withdrawn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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 29, 2017
    Last Updated
    July 22, 2019
    Sponsor
    Cairo University
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    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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