Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03755752
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arms: 2
• Actual Duration (Months): 8
• Patients Per Site Per Month: 8.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Diabetic	Procedure: Phacoemulsification with and without Trypan Blue capsule staining	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (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.
• Primary Purpose: Treatment
• Official Title: Safety of Trypan Blue Capsule Staining to Corneal Endothelium in Patients With Diabetic Retinopathy
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Jul 25, 2018
• Actual Study Completion Date: Aug 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phacoemulsification with Trypan Blue Phacoemulsification with Trypan Blue capsule staining of the anterior lens capsule in patients with diabetic retinopathy	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.
Experimental: Phacoemulsification without Trypan Blue Phacoemulsification without Trypan Blue capsule staining of the anterior lens capsule in patients with	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.

Outcome Measures

Primary Outcome Measures

1. Endothelial cell density [4 weeks]

Secondary Outcome Measures

1. Endothelial cell coefficient of variation [4 weeks]

2. Percent of hexagonal cells [4 weeks]

3. Mean corneal thickness [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Assiut		Egypt	71515

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Khaled Abdelazeem, Lecturer of Ophthalmology, Assiut University
• ClinicalTrials.gov Identifier: NCT03755752
• Other Study ID Numbers: 17300250
• First Posted: Nov 28, 2018
• Last Update Posted: Nov 28, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Cataract; Diabetic Retinopathy; Diminazene aceturate

Study Results

No Results Posted as of Nov 28, 2018