Using a Type of Blue Dye to Observe Bleb Function During Cataract Surgery

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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