Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients

NCT03755752 | Completed DMC

• 1 other identifier: 17300250
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract Diabetic

Outcome Measures

Primary Outcomes (1)

• Endothelial cell density

  4 weeks

Secondary Outcomes (3)

• Endothelial cell coefficient of variation

  4 weeks

• Percent of hexagonal cells

  4 weeks

• Mean corneal thickness

  4 weeks

Study Arms (2)

Phacoemulsification with Trypan Blue

EXPERIMENTAL

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

Phacoemulsification without Trypan Blue

EXPERIMENTAL

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

Procedure: Phacoemulsification with and without Trypan Blue capsule staining

Interventions

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.

Phacoemulsification with Trypan Blue; Phacoemulsification without Trypan Blue

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with bilateral cataract and diabetic retinopathy

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, 71515, Egypt

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

Phacoemulsification; Trypan Blue; Staining and Labeling

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures; Azo Compounds; Organic Chemicals; Naphthalenesulfonates; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Polycyclic Compounds; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Ophthalmology

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: January 1, 2018
• Primary Completion: July 25, 2018
• Study Completion: August 31, 2018
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)