Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients

Cataract Diabetic Clinical Trial

Official title:

Safety of Trypan Blue Capsule Staining to Corneal Endothelium in Patients With Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755752
• Other study ID #: 17300250
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: November 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 31, 2018
• Est. primary completion date: July 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Diabetic
• Diabetic Retinopathy

Intervention

Procedure:
• Phacoemulsification with and without Trypan Blue capsule staining
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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial cell density		4 weeks
Secondary	Endothelial cell coefficient of variation		4 weeks
Secondary	Percent of hexagonal cells		4 weeks
Secondary	Mean corneal thickness		4 weeks