Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Cataract Diabetic

Intervention / Treatment
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* Procedure: Phacoemulsification with and without Trypan Blue capsule staining


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phacoemulsification with Trypan Blue<br>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<br>* 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.<br>|
| Experimental: Phacoemulsification without Trypan Blue<br>Phacoemulsification without Trypan Blue capsule staining of the anterior lens capsule in patients with | Procedure: Phacoemulsification with and without Trypan Blue capsule staining<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell density |  | 4 weeks | 

Secondary Outcome Measures

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