Age Related CataractNCT07735000
Effect of Trypan Blue on Corneal Endothelial Cell Count During Phacoemulsification
A study testing Trypan Blue and Phacoemulcification in people with Age Related Cataract and Cataract, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Age Related Cataract, Cataract
- What is being tested?
- Trypan Blue and Phacoemulcification
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Mar 2024to 22 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Diabetes mellitus.
- Glaucoma.
- Previous ocular surgery.
- Corneal opacity.
- Pre-existing corneal endothelial disease.
- Uveitis.
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- Traumatic cataract.
- Complicated cataract.
- Any other ocular pathology that could affect corneal endothelial cell count or interfere with study outcomes.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Ophthalmology, Hayatabad Medical Complex, Peshawar, Pakistan
Peshawar, KPK, 25000
About this study
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.
Read the detailed description
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.
- Conditions
- Age Related Cataract, Cataract
- Being tested
- Trypan Blue, Phacoemulcification
- Keywords
- Phacoemulsification, Trypan blue, Cataract Surgery, Corneal Endothelium, Endothelial Cell Count, Specular Microscopy
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trypan BlueDrug
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.
PhacoemulcificationProcedure or surgery
Standard phacoemulsification with posterior chamber intraocular lens implantation performed using a standardized surgical technique
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Phacoemulcification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start22 Mar 2024
- Primary completion22 Sep 2024
- Study completion22 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age Related CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hayat Abad Medical Complex, Peshawar
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Naz Ullah, Hayat Abad Medical Complex, Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735000
- Sponsor's protocol ID
- 1
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study was conducted at a single center, participants did not provide consent for public data sharing, and data contain confidential information. Only aggregate, de-identified results are reported in publications.
Publications
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.
PubMed 21681214
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trypan Blue on Corneal Endothelial Cell Count During Phacoemulsification
- ClinicalTrials.gov ID
- NCT07735000
- Acronym / sponsor ID
- 1
- Conditions
- Age Related Cataract, Cataract
- Keywords
- Phacoemulsification, Trypan blue, Cataract Surgery, Corneal Endothelium, Endothelial Cell Count, Specular Microscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hayat Abad Medical Complex, PeshawarOther government
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 22 Sep 2024 (actual)
- Study completion
- 22 Sep 2024 (actual)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Trypan Blue Group | Experimental | Drug: Trypan Blue, Procedure: PhacoemulcificationParticipants 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 |
| Control Group | Active comparator | Procedure: PhacoemulcificationParticipants underwent standard phacoemulsification without trypan blue staining of the anterior lens capsule, followed by intraocular lens implantation using the same standardized surgical technique. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Diabetes mellitus.
- Glaucoma.
- Previous ocular surgery.
- Corneal opacity.
- Pre-existing corneal endothelial disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trypan BlueTrypan 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. | Drug | Trypan Blue Group |
| PhacoemulcificationStandard phacoemulsification with posterior chamber intraocular lens implantation performed using a standardized surgical technique | Procedure or surgery | Control Group, Trypan Blue Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 21681214Jhanji 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study was conducted at a single center, participants did not provide consent for public data sharing, and data contain confidential information. Only aggregate, de-identified results are reported in publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trypan Blue and Phacoemulcification in people with Age Related Cataract and Cataract, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Corneal Endothelial Cell Count (time frame: At 4 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07735000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.