Effect of Trypan Blue on Corneal Endothelial Cell Count During Phacoemulsification

NCT07735000 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age Related Cataract; Cataract

Keywords

Phacoemulsification; Trypan blue; Cataract Surgery; Corneal Endothelium; Endothelial Cell Count; Specular Microscopy

Outcome Measures

Primary Outcomes (2)

• Postoperative Corneal Endothelial Cell Count

  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.

  At 4 weeks after surgery

• Postoperative Corneal Endothelial Cell Count

  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.

  At 4 weeks after surgery

Study Arms (2)

Trypan Blue Group

EXPERIMENTAL

Participants underwent standard phacoemulsification with intracameral trypan blue staining of the anterior lens capsule before capsulorhexis, followed by intraocular lens implantation using a standardized surgical technique

Drug: Trypan Blue; Procedure: Phacoemulcification

Control Group

ACTIVE COMPARATOR

Participants underwent standard phacoemulsification without trypan blue staining of the anterior lens capsule, followed by intraocular lens implantation using the same standardized surgical technique.

Procedure: Phacoemulcification

Interventions

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.

Trypan Blue Group

Phacoemulcification PROCEDURE

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

Control Group; Trypan Blue Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hayat Abad Medical Complex, Peshawar: lead

Study Sites (1)

Department of Ophthalmology, Hayatabad Medical Complex, Peshawar, Pakistan

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (1)

• Jhanji V, Chan E, Das S, Zhang H, Vajpayee RB. Trypan blue dye for anterior segment surgeries. Eye (Lond). 2011 Sep;25(9):1113-20. doi: 10.1038/eye.2011.139. Epub 2011 Jun 17.

  PMID: 21681214 BACKGROUND

MeSH Terms

Conditions

Cataract

Interventions

Trypan Blue

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel groups. Group A underwent phacoemulsification with trypan blue staining of the anterior capsule, while Group B underwent the same procedure without trypan blue. Each participant remained in the assigned group throughout the study.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: March 22, 2024
• Primary Completion: September 22, 2024
• Study Completion: September 22, 2024
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)