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Surgical Therapy in Glaucoma 2014

J. James Thimons, O.D.,FAAOOphthalmic Consultants of Connecticut

Fairfield, CT

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Trends

• Streamlining of existing procedures– Express Minishunt– Use of Fibrin glue to reduce suturing– Alternative tube placement techniques

• Less invasive procedures– Canaloplasty– Trabectome– Gold Shunt– Glaukos shunt– ECP

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Considerations

• Impact of subsequent or prior procedures

• Realistic expectations on intraocular pressure control and continuing medical therapy

• Expected and tolerable side effects and complications

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Glaucoma Procedure Options that we have done

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Trabeculectomy with Express Minishunt

Express Minishunt Advantages

• Reduces operating time

• Eyes appear to be quieter earlier in post-op course

• No iridectomy

• Uniform opening

• If hypotony occurs, tends to be less severe

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Express Minishunt Disadvantages

• Needs some suturing as in trabeculectomy

• Dependent on patient healing

• Anti- metabolites still routinely used

• Patient has bleb

• Hypotony possible

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Reasons to use the Express

• Simplify procedure

• Shorten surgery time

• Decrease tissue manipulation

• Eliminate need for iridectomy

• Decrease chance of ostium obstruction

• Regulate flow in short term

• Create less short term inflammation

Arguments Against

• Expense

• Foreign body

• Metal in eye

• Corneal contact

Patient Selection

• Same as trabeculectomy

• May work better in high risk patients

• ICE patients

• NV patients

• Shallow/synechiae

Resident Surgery with Ex-PRESS

• No difference

– postoperative IOP

– proportional decrease in IOP

• Ex-PRESS group

– Significantly less medication to control IOP at 3 months

– No difference at 6 months or 1 year (P≥0.28)

– More Ex-PRESS patients had good IOP control without meds at 3 (P=0.057) and 6 months (P=0.076)

– No difference was found in the rates of sight-threatening complications (P≥0.22)

04/19/23Seider MI. Resident-performed Ex-PRESS Shunt Implantation Versus Trabeculectomy J Glaucoma. 2011 Apr 25. [Epub ahead of print]

Retrospective Case Series• Final percent IOP lowering was similar• Moorefields Bleb Grading System

– Less vascularity and height but more diffuse area associated with the Ex-PRESS blebs

• Fewer cases of early postoperative hypotony and hyphema• Quicker visual recovery

– The Ex-PRESS group required fewer postoperative visits compared with the trabeculectomy group (P < .000).

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Good TJ. Assessment of bleb morphologic features and postoperative outcomes after Ex-PRESSdrainage device implantation versus trabeculectomy. Am J Ophthalmol. 2011 Mar;151(3):507-13.e1. Epub 2011 Jan 13.

Ex-PRESS in prior operated eyes

• Success complete in 60(60%) and qualified in 24 (24%) eyes

• Mean IOP– 27.7 ± 9.2 mm Hg with 2.73 ± 1.1 – 14.02 ± 5.1 mm Hg with 0.72 ± 1.06 drugs (p <

0.0001)• Failure

– Uncontrolled IOP (11%)– bleb needling (4%)– persistent hypotony (1%)

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Lankaranian D. Intermediate-term results of the Ex-PRESS(TM) miniature glaucoma implant under a scleral flap in previously operated eyes. Clin Experiment Ophthalmol. 2010 Dec 22.

5 year study Ex-press vs Trabeculoectomy

• EX-PRESS more effective without medication– At year 1 12.8% of patients required IOP meds

after EX-PRESS implantation vs 35.9% after trabeculectomy

– At year 5 (41% versus 53.9%) • Responder rate was higher with EX-PRESS• Time to failure was longer• Surgical interventions for complications were

fewer after EX-PRESS implantation

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deJong et al. Five-year extension of a clinical trial comparing the EX-PRESS glaucomafiltration device and trabeculectomy in primary open-angle glaucoma. Clin Ophthalmol. 2011;5:527-33. Epub 2011 Apr 29.

Anesthetic Injection

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Conjunctiva Dissection

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25G Trochar

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Conjunctival Closure

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Post-op

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Results

• The mean preoperative IOP was 23.7 ± 9.3 and the mean postoperative IOP on the last follow up day was 10.4 ± 4.5 (p<0.001) over a mean follow up period of 199 days (range 29-608).

• The mean number of medications used preoperatively was 2.83 ± 1.1 and postoperatively was 0.023 ± 0.1 (p<0.001).

• Complications as hypotony, bleb leak, choroidal detachment, and transient hyphema were detected.

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Outcomes

• Studies overall suggest compared to trabeculectomy-– Less severe hypotony– Less bleeding– Less inflammation– Faster visual recovery– Similar long term IOP control

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Baerveldt

Baerveldt Patch Graft Placement

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Baerveldt Advantages

• Effective for almost all types of glaucoma

• Able to do when other procedures are not possible

• Not dependent on patient healing

• Can implant multiple devices

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Baerveldt Disadvantages

• Invasive- extensive dissection

• Large foreign object

• Diplopia possible

• Need some conjunctiva

• Very low pressures difficult to acheive

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ECP

ECP Advantages

• Quick procedure, especially in cataract setting

• Titratable

• Can be done with outflow procedures

• Hypotony unlikely

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ECP Disadvantages

• Some learning curve to avoid complications

• Inflammation possible

• IOP does not decrease rapidly

• Difficult to do in some eyes

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Canaloplasty

Effects of Suture TensionEx-Vivo Perfusion Study, Utilizing Morton Grant Flow

Model

– Pressurize globe to a range of physiologic pressures

– Apply tension to a suture implanted through the canal

– Measure outflow facility (uL/Min / mmHg)

(Image: iScience)

Canaloplasty

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IOP All Enrolled Eyes

0.0

5.0

10.0

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20.0

25.0

30.0

35.0

Baseline 1D 1W 1M 3M 6M 12M 18M 24M

IOP

[m

m H

g]

Canaloplasty Advantages

• Non-invasive

• No destruction of anatomy

• Hypotony unlikely

• Rapid recovery

• High Safety Profile

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Canaloplasty Disadvantages

• Longer operating times

• Learning curve

• Sometimes cannot cannulate

• Extensive prior scarring may eliminate possibility of performing procedure

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Trabectome

Trabectome Advantages

• Quick procedure

• Hypotony unlikely

• Ab interno approach eliminates dependence on dissection

• Can do in many types of glaucoma

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Trabectome Disadvantages

• Need to be able to visualize angle

• Bleeding common

• Very low IOPs unlikely

• Cannot do in eyes with canaloplasty

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Gold Shunt

SLX Clinical Results

Gold Shunt Advantages

• Straightforward procedure

• Suprachoroidal space attractive to work in

• No bleb

• Hypotony unlikely

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Gold Shunt Disadvantages

• Still in evolution

• Very low IOPs are not possible

• Device is fragile

• Titrability not proven in humans

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iStent (Glaukos)

Why Trabecular Bypass Surgery?

Stent / Efficacy:• Schlemm’s canal is part of the aqueous outflow pathway• iStent

® restores aqueous outflow chain by bypassing only the blockage

that occurs with glaucoma in the trabecular meshwork• IOP reductions to mid teens

Glaukos Efficacy

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4.14.4

5.75.9

5.3

4

3.4

0

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6

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8

Day 1 Day 7 Month 1 Month 2 Month 3 Month 6 Month 12

Study VisitM

ean

IOP

(m

m H

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Glaukos Advantages

• Quick to perform

• No dependence on prior procedures

• May be able to titrate with multiple procedures

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Glaukos Disadvantages

• Very low IOPs not likely

• Need open angle

• Placement of earlier device is sometimes difficult

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Glaucoma Surgical Procedures

• Many evolving and new procedures

• Surgeon has more options at his disposal than ever before

• Customization can be done to balance risk and reward for each individual patient

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noeckerrj@gmail.com