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Blue dye under the microscope: could a routine cataract tool damage corneal cells?

NCT ID NCT07735000

Knowledge-focused Sponsor: Hayat Abad Medical Complex, Peshawar Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This trial tests whether trypan blue, a dye sometimes used to stain the lens capsule during cataract surgery, affects the number of corneal endothelial cells — the inner layer of the cornea that keeps it clear. Sixty adults aged 45 to 75 with age-related cataracts will be randomly assigned to receive either standard cataract surgery or surgery with the dye. The main goal is to compare corneal cell counts after surgery to see if the dye causes extra cell loss.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trypan blue dye injected into the eye during cataract surgery
What this could lead to
If the dye is found to be safe for corneal cells, it could confirm its continued use in routine cataract surgery.
What could go wrong
This is a small, early-stage trial with only 60 participants, so results may not apply to all patients. The dye could potentially cause more cell loss than standard surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Mar 2024

Finished

Sep 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cataract senile cataract

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Age-related cataract Cataract

Contacts and locations

Locations

  • Department of Ophthalmology, Hayatabad Medical Complex, Peshawar, Pakistan

    Peshawar, KPK, 25000, Pakistan

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