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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03755752
Other study ID # 17300250
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date August 31, 2018

Study information

Verified date November 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date August 31, 2018
Est. primary completion date July 25, 2018
Accepts healthy volunteers No
Gender All
Age group 25 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
Egypt Faculty of Medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endothelial cell density 4 weeks
Secondary Endothelial cell coefficient of variation 4 weeks
Secondary Percent of hexagonal cells 4 weeks
Secondary Mean corneal thickness 4 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04977427 - Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes Phase 4
Recruiting NCT05386160 - Phacoemulsification Combined With Intravitreal Injection of Ranibizumab Prevent Postoperative Capillary Non-perfusion Zone Progress in Non-proliferative Diabetic Retinopathy Phase 4
Not yet recruiting NCT04668703 - Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion of Cataract Surgery for Diabetic Macular Edema N/A