aaberg jr en bloc emm 2014

Thomas M. Aaberg, Jr. M.D.Retina Specialists of Michigan

Michigan State University

Disclosures Synergetics-consultant. Allergan-speaker.

Macular Pucker SurgeryThe surgical removal of epiretinal macular

membranes (macular puckers)Klin Monbl AugenheilkdRobert Machemer, M.D.

1978 July; 173:36-42

6 patients with macular puckers 3 “spontaneous puckers” 3 after retinal detachment surgery

VITRECTOMY, Second Ed (1979)Robert Machemer, M.D.

Thomas M. Aaberg {Sr}, M.D.

Page 78… “The procedures about to be described are the most delicate in vitreous surgery and should be attempted only when the surgeon has mastered all other techniques. Simultaneously, they represent an aggressive attitude and are highly risky.”

Today…Surgical Results In general, patients can expect improvement

in metamorphopsia and regaining approximately half of the vision lost due to the pucker. Idiopathic Epiretinal Membranes

○ 80-90%: vision improves > 2 lines After Retinal Tears or Detachments

○ 65-90%: vision improves > 2 lines

RETINA. Ryan 4th Edition. 2006. Chapter 147 (McDonald, HR)

Today…Surgical Results

However… we can expect visually significant recurrent EMM in up to 5% of eyes.

RETINA. Ryan 4th Edition. 2006. Chapter 147 (McDonald, HR)

Can we reduce the 5% visually significant recurrence rate?

Medical management

Topical steroids or NSAIDs. Intraocular steroids Intraocular chemotherapeutic Example: Methotrexate

Surgical Management

Evidence to show that proliferating cells requires the appropriate surface/scaffold.

Retina: ILM is the scaffold.

Surgical Management

Does removing the internal limiting membrane… eliminates the scaffolding for gliotic proliferation? result in anatomic or functional benefit or harm?

Should we remove the ILM at all?

Trese, Chandler and Machemer (Graefes 1983)

○ Fragments of ILM found in 20 removed epimacular membranes with neurosensory retina cells on the retinal side of the ILM.

Similar histologic findings confirmed by other investigators

Case of a 77-year-old woman undergoes vitrectomy for macular pucker in her right eye

PAS 25x

PAS 100x

Courtesy of Hans Grossniklaus, MD

Case 8. 69 year old woman with surface wrinkling retinopathy undergoes vitrectomy

OCT appearance

PAS 25XCourtesy of Hans Grossniklaus, MD

Should we remove the ILM? ILM is the Mueller cell’s basement

membrane. The Mueller cells are integral cells

providing structure to the retinal anatomy.

Dysfunctional Mueller cells are thought to contribute to retinoschisis.

Foveola non-peeling internal limiting membrane surgery to prevent inner retinal damages in early

stage 2 idiopathic macula hole.Ho TC, et al. Graefes Arch Clin Exp Ophthalmol. 2014 Mar 23.

28 eyes with stage 2 macular hole Group 1: foveolar ILM nonpeeling group (14

eyes). A donut-shaped ILM was peeled off, leaving a 400-μm-diameter ILM over fovea.

Group 2: total peeling of foveal ILM group (14 eyes).



RESULTS: Smooth and symmetric umbo foveolar

contour was restored without inner retinal dimpling in all eyes in group 1, but not in group 2.



RESULTS: The final vision was better in group 1 (P = 0.011). 100% group 1 versus 50% group 2 regained the

inner segment/outer segment (IS/OS) line. Restoration of the umbo light reflex was found in

12 of 14 eyes in group 1 (86 %) but none in group 2 (0 %).

Reducing the 5% visually significant recurrence

Park DW et al (Ophthalmol 2003). Macular pucker removal with and without internal limiting membrane peeling: pilot trial Two surgeons, EMM Peel versus “Double Peel”

No ILM Peel ILM Peel

Vision Improved 80% 100%

5 line gainers 25% 30%

Recurrence 21% 0%

Reducing the 5% visually significant recurrence

Haritoglou et al. The effect of indocyanine-green on functional outcome of macular pucker surgery. AJO 2003. EMM peel vs “Double peel” with ICG assistance

No ILM Peel ILM Peel

Vision Improved 86% 55%

Visual field defects

0% 35%

Recurrence NA NA

ICG Saga 2000: Kadonosono et al (Arch Ophtho) Staining the Internal Limiting Membrane

Facilitates ILM removal 2001: Sippy et al (AJO) ICG toxic effect on cultured RPE cells

2002: Engelbrecht et al (AJO) Potential RPE ICG toxicity in macular hole pts

2003: Uemura et al (AJO) Visual field defects in 44% of ICG assisted

macular hole surgeries compared to 0% of non-ICG cases.

Comparative evaluation of no dye assistance, indocyanine green and triamcinolone acetonide for internal limiting

membrane peeling during macular hole surgery.Tsipursky MS, et al. Retina. 2013 Jun;33(6):1123-31.

Retrospective, comparative interventional case series of PPV/ILM peel.

435 eyes with macular hole assigned to 3 groups: Group 1: no dye assistance Group 2: ICG –assisted Group 3: Triamcinolone-assisted.

Comparative evaluation of no dye assistance, indocyanine green and triamcinolone acetonide for internal limiting

membrane peeling during macular hole surgery.Tsipursky MS, et al. Retina. 2013 Jun;33(6):1123-31.

RESULTS: Closure rate with a single surgery

Group 1: 95 % Group 2: 94 % Group 3: 96 %

Visual Acuity of 20/50 or better Group 1: 78 % Group 2: 66 % Group 3: 81 %

Comparisons of cone electroretinograms after indocyanine green-, brilliant blue G-, or triamcinolone acetonide-

assisted macular hole surgery.Machida S, et al. Graefes Arch Clin Exp Ophthalmol. 2014 Mar 2

To compare the function of retinal ganglion cells (RGCs) using the photopic negative response (PhNR) in patients who had ICG-assisted Brilliant blue G assisted, OR Triamcinolone assistedIILM peeling during macular hole surgery.



RESULTS: All macular holes were closed Visual improvement similar amongst the groups. No significant difference between the

preoperative and postoperative RNFL thickness.



BUT: The implicit times of the a-waves and b-waves

were significantly prolonged in all groups Oscillatory potential amplitude were significantly

decreased postoperatively in all groups. The postoperative photopic negative response

amplitudes was significantly lower in the ICG group than in the BBG or TA



Suggests removing ILM may change retinal function.

Suggests ICG may have toxic effects.

Question:Compared to traditional macular pucker

surgery will en bloc removal of ILM and EMM using ICG dye assistance 1) Have any affect (detrimental or beneficial)2) Reduce visually significant recurrence rate

Minimizing Risk of ICG Dilute concentration Osmolarity Avoiding “bare retina” or “bare RPE”

Perhaps the cellular EMM is a protective barrier between ICG and macular retina

No re-staining retina after membrane peel

Study Design Inclusion criteria

Macular puckers○ Idiopathic○ Post RD○ Vitreomacular traction with surface gliosis

Follow-up greater than 3 months Exclusion

Concurrent eye disease which may confound outcomes (ex: advanced glaucoma, AMD, AION, etc)

Surgical Procedure Two site study

Surgeon 1 (Group 1): PPV/MP Surgeon 2 (Group 2): PPV/en bloc ILM-MP

ICG preparation 2mg ICG dye mixed with 2 cc of sterile water. An

additional 3 cc of BSS added to ICG mixture for a final concentration of 0.4 mg/cc.

Intra-operative use of ICG Delivered in a fluid filled eye Gently irrigated over macula Allowed to reside in eye within the time it takes to

exchange the dye cannula for the vitrectomy instrument and evacuate the excess.

Results Total number of patients: 117

Group 1: 37 Group 2: 80

Preop Visual Acuity Group 1: .53 logMAR (20/68) Group 2: .58 logMAR (20/74)

○ p = 0.374

Follow-up period Group 1: mean of 12 months Group 2: mean of 7 months

Results: Final Visual Acuity

Group 1: .36 logMAR (20/46) Group 2: .34 logMAR (20/44)

p = 0.727

8037 8037N =

en bloc (Y/N)

YN

2.0

1.5

1.0

.5

0.0

-.5

Pre-op VA

Final LogMAR VA

117115

75

106

21

15

7551

321

2410812

Group 1 Group 2

Results: Recurrence Rates Overall recurrence rates

Group 1: 6 (16%) Group 2: 1 (1.3%)

○ p = 0.002 (chi-square), 0.004 (fisher’s)

Visually Significant (requiring reop) Group 1: 1 (3%) Group 2: 0 (0%)

○ p = 0.140 (chi-square), 0.316 (fisher’s)

Results: Complications Group 1: None Group 2: Macular hole (one patient). Visual field defects

Formal fields not done None reported

RPE alterations None noted

Other Studies Double Peel

○ Shimada H, et al. Ophthalmol, 2009○ Feldman A, et al. Eur J Ophthalmol, 2008○ Lai TY, et al. Graefe’s. 2007○ Kwok A, et al. Clin Exp Ophthalmol. 2005○ Kwok A, et al. Eye, 2004○ Haritoglou C, et al. Am J Ophthalmol. 2003○ Stalmans P, et al. Br J Ophthalmol. 2003○ Park DW, et al. Ophthalmol. 2003

Close to En Bloc○ Hillenkamp J, et al. Graefe’s, 2007

Goal of EMM peel only though ILM often removed○ Koestinger A, et al. Eur J Ophthalmol, 2005

Overall conclusions when comparing EMM without and with ILM peel

Double Peel○ Vision statistically no different (majority) One study reported visual improvement with ILM peel One study reported worsen of vision with ILM peel

○ Recurrence rate statistically no different or reduced with ILM peel

Close to En Bloc○ No statistical difference in visual outcomes○ No statistical difference in recurrence rate○ Potential toxicity in ICG cases Visual field defects

Comment Intuitively, en bloc removal of ILM-EMM

complex seems less traumatic and more efficient than performing a “double-peel.”

ILM removal appears to reduce the recurrence rate of epimacular membrane re-proliferation.

Visual significance … perhaps none.

Patient’s Perspective “I want to see as clearly as possible”

Acuity Lack of Distortion

“I do not want to have complications” “I do not want repeat surgery”

Need for a Definitive Answer

Surgical Consortium Multicenter group of vitreoretinal surgeons Surgical procedure will be assigned by physician’s

preference. Based on pilot data for a 2-arm trial, a total of 550

patients will need to be enrolled (275 patients per arm).○ Study visions○ Contrast sensitivity○ Formal visual fields○ OCT○ Cost analysis (surgical time, equipment, etc)○ +/- ERG testing

You are all welcome in Michigan

Thank You !Thank You !

aaberg jr en bloc emm 2014

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