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Completed

NCT Number: NCT03755752

Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients

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.

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Key information

Conditions

Cataract Diabetic

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Asyut, 71515, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phacoemulsification with and without Trypan Blue capsule staining

Procedure

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 outcomes

  1. Endothelial cell density

    Time frame: 4 weeks

Secondary outcomes

  1. Endothelial cell coefficient of variation

    Time frame: 4 weeks

  2. Percent of hexagonal cells

    Time frame: 4 weeks

  3. Mean corneal thickness

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 28, 2018
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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