Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients

November 26, 2018 updated by: Khaled Abdelazeem, Assiut University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial cell density
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Endothelial cell coefficient of variation
Time Frame: 4 weeks
4 weeks
Percent of hexagonal cells
Time Frame: 4 weeks
4 weeks
Mean corneal thickness
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

July 25, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

November 26, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17300250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract Diabetic

Clinical Trials on Phacoemulsification with and without Trypan Blue capsule staining

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe