GlaucomaNCT02526706
Using a Type of Blue Dye to Observe Bleb Function During Cataract Surgery
A study testing VisionBlue in people with Glaucoma, run by Wills Eye at 1 site in United States.
Trial summary
The investigators aim to conduct a prospective clinical pilot study to investigate the use of VisionBlue staining administered during cataract surgery to 20 patients with history of trabeculectomy for glaucoma as a means to assess functioning of an existing filtering bleb. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- VisionBlue
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Oct 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glaucoma patients with history of previous trabeculectomy surgery who are scheduled for cataract surgery.
- Glaucoma defined as (both requirements must be met): 1) Characteristic glaucomatous disc damage as demonstrated by local narrowing, notching, or absence of the neuroretinal rim in the absence of disc pallor elsewhere. 2) Characteristic glaucomatous visual field (VF) deficits.
- Over 21 years of age
Who cannot join
- Intraocular surgery or laser procedure within 3 months prior to the planned cataract surgery.
- Active ocular infection or inflammation.
- History of glaucoma drainage device (tube-shunt) implantation.
- Allergy to VisionBlue or history of allergy to other ophthalmic dyes
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital, Glaucoma Service
Philadelphia, Pennsylvania, 19107
About this study
Official title: VisionBlue for the Assessment of Filtering Bleb Functioning During Cataract Surgery
The investigators aim to conduct a prospective clinical pilot study to investigate the use of VisionBlue staining administered during cataract surgery to 20 patients with history of trabeculectomy for glaucoma as a means to assess functioning of an existing filtering bleb. The investigators also aim to develop a standard classification system for assessing filtering bleb function during cataract surgery.
Read the detailed description
Twenty (20) patients with history of trabeculectomy who have been scheduled for cataract extraction with posterior chamber intraocular lens implant, will be recruited from Wills Eye Hospital Glaucoma Service.
Subjects will undergo a comprehensive ophthalmic evaluation prior to scheduling cataract surgery. The following data will be recorded: Demographic information including age, race, and gender, Best corrected visual acuity, IOP measured by Goldmann applanation tonometry, Bleb morphology evaluation using the Indiana Bleb Appearance Grading Scale (IBAGS), Filtering bleb photographs and anterior segment OCT of the bleb will be taken at the baseline examination.
The patient will be taken to the operating room and will be prepped.Non-preserved Lidocaine (1%) will be injected into the anterior chamber for anesthesia, followed by injection of one complete vial of VisionBlue (0.5 mL). An injection of BSS will be administered through the paracentesis port until the IOP is approximately 20mHg (estimated by the surgeon by palpation), with a waiting period of 20 seconds. Another injection of BSS will then be administered to wash out the VisionBlue. A set of microscopic photographs will be taken through the intraoperative microscope following washout of VisionBlue, with bleb grading performed by the physician: 1+ to 4+ stain (based on standard set of photos).
Cataract extraction will then take place following typical phacoemulsification procedure. At the end of the case, after insertion of the intraocular lens implant into the capsular bag and removal of viscoelastic material from the eye, an additional set of microscope photographs will be taken and graded on same scale.
The time (in minutes) between the initial and the final bleb grading will be measured and recorded. Intraoperative complications will be recorded as well.
Follow-up of subjects will take place post-operatively at 1 day, 1 week, 1 month, 3 month, and 6 month follow-up visits. Color photos of bleb will be performed post-operatively at 1 day, 1 month, and 6 months. At each visit, we will also record the number of glaucoma medications, post-operative complications and need for re-operations.
- Conditions
- Glaucoma
- Being tested
- VisionBlue
- Keywords
- Bleb filtration, VisionBlue
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisionBlueOther
VisionBlue is a staining solution designed to assist in making complete capsulorhexis during cataract surgery. The dye is injected into the anterior chamber via a paracentesis port and stains the anterior lens capsule, assisting in adequate visualization of the anterior lens capsule. This study proposes to explore the use of VisionBlue during cataract surgery as a means to assess functioning of an existing filtering bleb placed during prior trabeculectomy in patients with glaucoma.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma Study Group | Experimental | Glaucoma patients scheduled for trabeculectomy were recruited for this study and VisionBlue dye is injected prior to the surgery. Receives: Other: VisionBlue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intraocular pressure (IOP) post surgery
IOP is measured pre and post operation and in all the follow up visits.
Measured: 6 months
The Indiana Bleb Appearance Grading System (IBAGS) will be used for bleb grading
Evaluation based on pre-operative bleb photography will be compared to intraoperative VisionBlue bleb scoring by using Indiana Bleb Appearance Grading System (IBAGS) as a standard structured framework for comparison. The IBAGS method uses bleb photography to create a score based on bleb height (0 to 3), extent (0 to 3), vascularity (0 to 4), and Seidel test leakage (0 to 2).
Measured: 6 months
Change in Glaucoma medication from pre to post surgery
Observe the changes in glaucoma medication after surgery procedure and at all follow up visits
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlene Moster, MD, Wills Eye
- Investigators
- Marlene Moster, MD, Principal investigator, Wills Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526706
- Sponsor's protocol ID
- 15-494
- Status last verified
- Nov 2016
- First submitted
- 10 Aug 2015
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VisionBlue for the Assessment of Filtering Bleb Functioning During Cataract Surgery
- ClinicalTrials.gov ID
- NCT02526706
- Acronym / sponsor ID
- 15-494
- Conditions
- Glaucoma
- Keywords
- Bleb filtration, VisionBlue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Aug 2015 (estimated)
- 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.
The investigators aim to conduct a prospective clinical pilot study to investigate the use of VisionBlue staining administered during cataract surgery to 20 patients with history of trabeculectomy for glaucoma as a means to assess functioning of an existing filtering bleb. The investigators also aim to develop a standard classification system for assessing filtering bleb function during cataract surgery.
Detailed description
Twenty (20) patients with history of trabeculectomy who have been scheduled for cataract extraction with posterior chamber intraocular lens implant, will be recruited from Wills Eye Hospital Glaucoma Service.
Subjects will undergo a comprehensive ophthalmic evaluation prior to scheduling cataract surgery. The following data will be recorded: Demographic information including age, race, and gender, Best corrected visual acuity, IOP measured by Goldmann applanation tonometry, Bleb morphology evaluation using the Indiana Bleb Appearance Grading Scale (IBAGS), Filtering bleb photographs and anterior segment OCT of the bleb will be taken at the baseline examination.
The patient will be taken to the operating room and will be prepped.Non-preserved Lidocaine (1%) will be injected into the anterior chamber for anesthesia, followed by injection of one complete vial of VisionBlue (0.5 mL). An injection of BSS will be administered through the paracentesis port until the IOP is approximately 20mHg (estimated by the surgeon by palpation), with a waiting period of 20 seconds. Another injection of BSS will then be administered to wash out the VisionBlue. A set of microscopic photographs will be taken through the intraoperative microscope following washout of VisionBlue, with bleb grading performed by the physician: 1+ to 4+ stain (based on standard set of photos).
Cataract extraction will then take place following typical phacoemulsification procedure. At the end of the case, after insertion of the intraocular lens implant into the capsular bag and removal of viscoelastic material from the eye, an additional set of microscope photographs will be taken and graded on same scale.
The time (in minutes) between the initial and the final bleb grading will be measured and recorded. Intraoperative complications will be recorded as well.
Follow-up of subjects will take place post-operatively at 1 day, 1 week, 1 month, 3 month, and 6 month follow-up visits. Color photos of bleb will be performed post-operatively at 1 day, 1 month, and 6 months. At each visit, we will also record the number of glaucoma medications, post-operative complications and need for re-operations.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma Study Group | Experimental | Other: VisionBlueGlaucoma patients scheduled for trabeculectomy were recruited for this study and VisionBlue dye is injected prior to the surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Glaucoma patients with history of previous trabeculectomy surgery who are scheduled for cataract surgery.
- Glaucoma defined as (both requirements must be met): 1) Characteristic glaucomatous disc damage as demonstrated by local narrowing, notching, or absence of the neuroretinal rim in the absence of disc pallor elsewhere. 2) Characteristic glaucomatous visual field (VF) deficits.
- Over 21 years of age
Key exclusion criteria (4 listed)
- Intraocular surgery or laser procedure within 3 months prior to the planned cataract surgery.
- Active ocular infection or inflammation.
- History of glaucoma drainage device (tube-shunt) implantation.
- Allergy to VisionBlue or history of allergy to other ophthalmic dyes
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 |
|---|---|---|
| VisionBlueVisionBlue is a staining solution designed to assist in making complete capsulorhexis during cataract surgery. The dye is injected into the anterior chamber via a paracentesis port and stains the anterior lens capsule, assisting in adequate visualization of the anterior lens capsule. This study proposes to explore the use of VisionBlue during cataract surgery as a means to assess functioning of an existing filtering bleb placed during prior trabeculectomy in patients with glaucoma. | Other | Glaucoma Study Group |
Primary outcome
Change in intraocular pressure (IOP) post surgery
Time frame: 6 months
IOP is measured pre and post operation and in all the follow up visits.
The Indiana Bleb Appearance Grading System (IBAGS) will be used for bleb grading
Time frame: 6 months
Evaluation based on pre-operative bleb photography will be compared to intraoperative VisionBlue bleb scoring by using Indiana Bleb Appearance Grading System (IBAGS) as a standard structured framework for comparison. The IBAGS method uses bleb photography to create a score based on bleb height (0 to 3), extent (0 to 3), vascularity (0 to 4), and Seidel test leakage (0 to 2).
Change in Glaucoma medication from pre to post surgery
Time frame: 6 months
Observe the changes in glaucoma medication after surgery procedure and at all follow up visits
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 22 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
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.
Marlene Moster, MD principal investigator
Wills Eye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VisionBlue in people with Glaucoma, run by Wills Eye at 1 site in United States.
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 3 inclusion and 4 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 22 Nov 2016. 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 United States. 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?
Change in intraocular pressure (IOP) post surgery (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2016.