Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-08-31

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.

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Detailed Description

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Conditions

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Cataract Diabetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Randomization was done using an envelope technique wherein, after each patient was placed on the operating bed, the surgeon opened the patient's corresponding envelope, which contained information about whether Trypan Blue should be used for anterior capsular staining or not.

Study Groups

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Phacoemulsification with Trypan Blue

Phacoemulsification with Trypan Blue capsule staining of the anterior lens capsule in patients with diabetic retinopathy

Group Type EXPERIMENTAL

Phacoemulsification with and without Trypan Blue capsule staining

Intervention Type 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.

Phacoemulsification without Trypan Blue

Phacoemulsification without Trypan Blue capsule staining of the anterior lens capsule in patients with

Group Type EXPERIMENTAL

Phacoemulsification with and without Trypan Blue capsule staining

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No