Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients

NCT03755752 — Not applicable, Completed, 65 participants, Assiut University

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

Registry	NCT03755752
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: single, treatment
Enrollment	65 (Actual)
Sponsor	Assiut University (Other)
Conditions	Cataract Diabetic
Interventions	Phacoemulsification with and without Trypan Blue capsule staining (Procedure)
Dates	start 2018-01-01, primary completion 2018-07-25, completion 2018-08-31, first posted 2018-11-28, last updated 2018-11-28
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Phacoemulsification with Trypan Blue	Experimental	Procedure: Phacoemulsification with and without Trypan Blue capsule staining	Phacoemulsification with Trypan Blue capsule staining of the anterior lens capsule in patients with diabetic retinopathy
Phacoemulsification without Trypan Blue	Experimental	Procedure: Phacoemulsification with and without Trypan Blue capsule staining	Phacoemulsification without Trypan Blue capsule staining of the anterior lens capsule in patients with

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.

+Outcome measures

Primary outcomes

Endothelial cell density [4 weeks]

Secondary outcomes

Endothelial cell coefficient of variation [4 weeks]
Percent of hexagonal cells [4 weeks]
Mean corneal thickness [4 weeks]

+Eligibility

Sex: All, ages: 25 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
Faculty of Medicine	Asyut	Egypt

+Publications

Results publication: Abdelmotaal H, Abdelazeem K, Hussein MS, Omar AF, Ibrahim W. Safety of Trypan Blue Capsule Staining to Corneal Endothelium in Patients with Diabetic Retinopathy. J Ophthalmol. 2019 Mar 27;2019:4018739. doi: 10.1155/2019/4018739. eCollection 2019. PMID 31032113