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CompletedNCT03755752Updated Nov 28, 2018

Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients

An interventional study of Phacoemulsification with and without Trypan Blue capsule staining in Cataract Diabetic, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-11-28.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2018, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Cataract Diabetic
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In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 65 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with bilateral cataract and diabetic retinopathy

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Phacoemulsification with Trypan Blue

    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

  • Experimental
    Phacoemulsification without Trypan Blue

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

    Procedure: Phacoemulsification with and without Trypan Blue capsule staining

Interventions

  • ProcedurePhacoemulsification 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.

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What researchers measure

Primary outcomes

  1. Endothelial cell density

    Time frame: 4 weeks

Secondary outcomes

  1. Endothelial cell coefficient of variation

    Time frame: 4 weeks

  2. Percent of hexagonal cells

    Time frame: 4 weeks

  3. Mean corneal thickness

    Time frame: 4 weeks

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Study locations

1 site
  • Faculty of Medicine
    Assiut, 71515, Egypt
08

References and documents

Publications

  • 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. PubMed 31032113 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03755752
Lead sponsor
Assiut University
Responsible party
Khaled Abdelazeem (Lecturer of Ophthalmology, Assiut University) — Principal investigator
First posted
Nov 28, 2018
Start date
Jan 1, 2018
Primary completion
Jul 25, 2018
Completion
Aug 31, 2018
Last update
Nov 28, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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