NCT02526706

Brief 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. The investigators also aim to develop a standard classification system for assessing filtering bleb function during cataract surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

August 10, 2015

Last Update Submit

November 19, 2016

Conditions

Glaucoma

Keywords

Bleb filtrationVisionBlue

Outcome Measures

Primary Outcomes (3)

  • Change in intraocular pressure (IOP) post surgery

    IOP is measured pre and post operation and in all the follow up visits.

    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).

    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

    6 months

Study Arms (1)

Glaucoma Study Group

EXPERIMENTAL

Glaucoma patients scheduled for trabeculectomy were recruited for this study and VisionBlue dye is injected prior to the surgery.

Other: VisionBlue

Interventions

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.

Glaucoma Study Group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Hospital, Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Trypan Blue

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Azo CompoundsOrganic ChemicalsNaphthalenesulfonatesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsPolycyclic Compounds

Study Officials

  • Marlene Moster, MD

    Wills Eye

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 18, 2015

Study Start

August 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)