Back to resultsSafety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients
Primary Purpose
Cataract Diabetic
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Phacoemulsification with and without Trypan Blue capsule staining
Sponsored by
About this trial
This is an interventional treatment trial for Cataract Diabetic
Eligibility Criteria
Inclusion Criteria:
- Patients with bilateral cataract and diabetic retinopathy
Exclusion Criteria:
- History of ocular surgery Active
- ocular inflammation Corneal opacities
- Pseudoexfoliation syndrome
- Anterior chamber flare and (or) other signs of possibly altered blood - queous barrier
- Iris neovascularization (rubeosis)
- Uncontrolled glaucoma
- Congenital or traumatic cataracts
- History or present chronic use of topical or systemic steroids
- Poor papillary dilatation (<6 mm)
- Specular microscopy cell density < 2000 cell/mm2
- Patients who experienced complications fromphacoemulsification
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Phacoemulsification with Trypan Blue
Phacoemulsification without Trypan Blue
Arm Description
Phacoemulsification with Trypan Blue capsule staining of the anterior lens capsule in patients with diabetic retinopathy
Phacoemulsification without Trypan Blue capsule staining of the anterior lens capsule in patients with
Outcomes
Primary Outcome Measures
Endothelial cell density
Secondary Outcome Measures
Endothelial cell coefficient of variation
Percent of hexagonal cells
Mean corneal thickness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03755752
Brief Title
Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients
Official Title
Safety of Trypan Blue Capsule Staining to Corneal Endothelium in Patients With Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
July 25, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study examines the use of Trypan Blue staining of the corneal endothelium in patients undergoing phacoemulsification. It is a single-center prospective, randomized individual cohort study. One eye in each patient with diabetic retinopathy will undergo phacoemulsification without Trypan Blue capsule staining (control eye) while the other eye will undergo phacoemulsification with Trypan Blue capsule staining (study eye). Both eyes will undergo intraocular lens implantation. Preoperative and four-week postoperative quantitative and qualitative morphometric endothelial cell analyses of the cornea will be performed using noncontact specular microscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Diabetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Masking Description
Randomization was done using an envelope technique wherein, after each patient was placed on the operating bed, the surgeon opened the patient's corresponding envelope, which contained information about whether Trypan Blue should be used for anterior capsular staining or not.
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phacoemulsification with Trypan Blue
Arm Type
Experimental
Arm Description
Phacoemulsification with Trypan Blue capsule staining of the anterior lens capsule in patients with diabetic retinopathy
Arm Title
Phacoemulsification without Trypan Blue
Arm Type
Experimental
Arm Description
Phacoemulsification without Trypan Blue capsule staining of the anterior lens capsule in patients with
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification with and without Trypan Blue capsule staining
Intervention Description
Phacoemulsification for patients with diabetic retinopathy having cataract in both eyes. One eye underwent phacoemulsification with trypan blue capsule staining and the other eye underwent phacoemulsification without trypan blue.
Primary Outcome Measure Information:
Title
Endothelial cell density
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Endothelial cell coefficient of variation
Time Frame
4 weeks
Title
Percent of hexagonal cells
Time Frame
4 weeks
Title
Mean corneal thickness
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with bilateral cataract and diabetic retinopathy
Exclusion Criteria:
History of ocular surgery Active
ocular inflammation Corneal opacities
Pseudoexfoliation syndrome
Anterior chamber flare and (or) other signs of possibly altered blood - queous barrier
Iris neovascularization (rubeosis)
Uncontrolled glaucoma
Congenital or traumatic cataracts
History or present chronic use of topical or systemic steroids
Poor papillary dilatation (<6 mm)
Specular microscopy cell density < 2000 cell/mm2
Patients who experienced complications fromphacoemulsification
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31032113
Citation
Abdelmotaal H, Abdelazeem K, Hussein MS, Omar AF, Ibrahim W. Safety of Trypan Blue Capsule Staining to Corneal Endothelium in Patients with Diabetic Retinopathy. J Ophthalmol. 2019 Mar 27;2019:4018739. doi: 10.1155/2019/4018739. eCollection 2019.
Results Reference
derived
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Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients
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