Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients
Not Applicable
Completed
- Conditions
- Cataract Diabetic
- Interventions
- Procedure: Phacoemulsification with and without Trypan Blue capsule staining
- Registration Number
- NCT03755752
- Lead Sponsor
- Assiut University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Phacoemulsification with Trypan Blue 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 Phacoemulsification with and without Trypan Blue capsule staining Phacoemulsification without Trypan Blue capsule staining of the anterior lens capsule in patients with
- Primary Outcome Measures
Name Time Method Endothelial cell density 4 weeks
- Secondary Outcome Measures
Name Time Method Endothelial cell coefficient of variation 4 weeks Percent of hexagonal cells 4 weeks Mean corneal thickness 4 weeks
Trial Locations
- Locations (1)
Faculty of Medicine
🇪🇬Assiut, Egypt