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Completed

NCT Number: NCT07735000

Effect of Trypan Blue on Corneal Endothelial Cell Count During Phacoemulsification

This randomized controlled trial evaluated the effect of trypan blue on corneal endothelial cell count in patients undergoing phacoemulsification for age-related cataract. Sixty participants were randomly assigned to undergo phacoemulsification either with trypan blue-assisted anterior capsule staining or without trypan blue. The primary objective was to compare postoperative corneal endothelial cell count between the two groups using specular microscopy to determine whether trypan blue has an effect on corneal endothelial cell loss during cataract surgery.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Hayatabad Medical Complex, Peshawar, Pakistan

Peshawar, KPK, 25000, Pakistan

About this study

Age-related cataract is one of the leading causes of reversible visual impairment worldwide. Trypan blue is commonly used during phacoemulsification to stain the anterior lens capsule, particularly in mature or dense cataracts, to facilitate continuous curvilinear capsulorhexis. Although trypan blue improves intraoperative visualization, concerns remain regarding its potential effect on the corneal endothelium.

This single-center, parallel-group, randomized controlled trial was conducted at the Department of Ophthalmology, Hayatabad Medical Complex, Peshawar, Pakistan. Sixty patients aged 45 to 75 years with age-related cataract scheduled for phacoemulsification were randomly allocated in a 1:1 ratio to undergo phacoemulsification either with trypan blue-assisted anterior capsule staining or without trypan blue. All procedures were performed using a standardized surgical technique by the same surgical team.

The primary outcome was postoperative corneal endothelial cell count measured by specular microscopy. The study compared postoperative endothelial cell counts and endothelial cell loss between the two treatment groups to evaluate the effect of trypan blue on corneal endothelial safety during phacoemulsification.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 45 to 75 years.
  • Diagnosed with age-related cataract.
  • Scheduled to undergo phacoemulsification with posterior chamber intraocular lens implantation.
  • Able and willing to provide written informed consent.

Exclusion criteria

  • Diabetes mellitus.
  • Glaucoma.
  • Previous ocular surgery.
  • Corneal opacity.
  • Pre-existing corneal endothelial disease.
  • Uveitis.
  • Traumatic cataract.
  • Complicated cataract.
  • Any other ocular pathology that could affect corneal endothelial cell count or interfere with study outcomes.

Treatment and study plan

Trypan Blue

Drug

Trypan blue was administered intracamerally to stain the anterior lens capsule before continuous curvilinear capsulorhexis during phacoemulsification. The dye was removed after adequate staining, and the remaining surgical procedure was completed using the standard technique.

Phacoemulcification

Procedure

Standard phacoemulsification with posterior chamber intraocular lens implantation performed using a standardized surgical technique

Primary outcomes

  1. Postoperative Corneal Endothelial Cell Count

    Time frame: At 4 weeks after surgery

    Corneal endothelial cell density was measured by specular microscopy and reported as cells/mm². The mean postoperative endothelial cell count was compared between the trypan blue group and the control group.

  2. Postoperative Corneal Endothelial Cell Count

    Time frame: At 4 weeks after surgery

    Corneal endothelial cell density was measured by specular microscopy and reported as cells/mm². The mean postoperative endothelial cell count was compared between participants undergoing phacoemulsification with trypan blue and those undergoing phacoemulsification without trypan blue.

Sponsors and collaborators

Lead sponsor

Hayat Abad Medical Complex, Peshawar

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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