Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients

Assiut University

Status

Completed

Conditions

Cataract Diabetic

Treatments

Procedure: Phacoemulsification with and without Trypan Blue capsule staining

Study type

Interventional

Funder types

Other

Identifiers

NCT03755752

17300250

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

All

Ages

25 to 70 years old

Volunteers

No Healthy Volunteers

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