Vitreomacular Traction What should I do?static.livemedia.gr/livemedia/documents/al4459_us... ·...
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Vitreomacular TractionWhat should I do?
A.N. Stangos 1,2,3
1 Centre Ophtalmologique de Florissant, Geneva2 Rothschild Foundation, Eye Research Unit, Geneva
3Moorfields Eye Hospital, London
The VitreousVol.: 4.2 ml (98% water)
Dilute Meshwork of:
• Collagen
Type II (75%)
Type IX (15%)
Type V/XI (10%)
• Hyaluronan
Vitreo-Retinal Interface:
• ILM
• Basement Membrane
• Posterior Hyaloid
Extracellular matrix “glue”:
• Laminin
• Fibronectin
Vitreous Degeneration
HA/collagen alterations
Aggregation of collagen fibrils
Liquefaction
Weakening of the vitreo-retinal adhesion
Age-related process
�Gender
�Axial length
�Trauma/Sx
Posterior Vitreous Detachment
Anomalous* PVD
LiquefactionWeakening of the
vitreoretinaladhesion
* Sebag J. Graefe’s Arch Clin Exp Ophthalmol 2004; 242:690-8
Retinal TearVHVMT
VMT is associated with…
Cystoid Macular Edema
Epiretinal Membrane
Macular Hole
AMD pathogenesis
Worsening of wAMD
Poor Response to anti-VEGF for wAMD
Worsening of Diabetic Macular Edema
Management of VMT
• Observation (10-60% spontaneous resolution)
• Vitrectomy (mechanical release)
• Pharmacologic Vitreolysis
Enzymatic
Non-specific Substrate Specific
PlasminChondroitinase
OcriplasminHyaluronidase
DispaseMatrix Metalloproteinases
Non-enzymatic
Ocriplasmin0.1ml (125μg)
• Phase III RCT’s (MIVI-006 & MIVI-007)
Inclusion Criteria Exclusion Criteria
• > 18 years old
• Symptomatic
• VMT within 6mm from the fovea
• ± FTMH ≤ 400μm
• ± ERM
• BCVA ≤ 20/25 (6/9)
• PDR
• wet AMD
• RVO
• aphakia
• > -8 sphdiopters
• uncontrolled glaucoma
• previous RD repair
• phacodonesis
Ocriplasmin (MIVI 006 & 007)Results (@ 28 days)
Ocriplasmin Placebo p
VMT release (all)ERM (+)ERM (-)
26.5%8.7%
37.4%
10.1%1.5%
14.3%
<0.001<0.046<0.001
MH closure (all)<250μm
250-400 μm
41%58.3%24.6%
11.0% <0.001
PVD 13.4% 3.7% <0.001
VA gain >3 ETDRS linesPPV @ 6/12
12.3%17.7%
6.4%26.6%
0.020.02
Ocriplasmin (MIVI 006 & 007)Complications
Ocriplasmin Placebo p
Any 68.4% 53.5% <0.001
FloatersPhotopsiaeConj HemorrhagePain
16.8%11.8%14.6%13.5%
7.5%2.7%
12.8%5.9%
0.002<0.001
0.530.005
MH formation 5.2% 8.6% 0.15
RD 0.4% 1.6% 0.16
Ocriplasmin0.1ml (125μg)
Multivariate analysis for higher success (VMT release):
• FTMH
• VMA ≤ 1500μm
• Phakic
• No ERM
• Age < 65 years
Indication for Ocriplasmin?
Indication for Ocriplasmin?
Indication for Ocriplasmin?
Indication for Ocriplasmin?
Indication for Ocriplasmin?
Non-enzymatic Vitreolysis
Our Experience
Purpose
To evaluate the efficacy of a single intravitreal injection of expansile gas
(C3F8) in releasing VMT
Methods
• Retrospective, interventional case series
• 15 eyes of 14 consecutive patients with symptomaticand persistent VMT on SD-OCT
• 0.3ml of 100% C3F8injected via pars plana between Sep 09 and May 2011 in the OR
• Data collection (VA, IOP, biomicroscopy findings, SD-OCT) at baseline and 1 month following treatment
• STATA® v.6 software for statistical analysis
Criteria for C3F8 Injection
Inclusion• Persistent VMT
(> 3/12 duration)
• Symptomatic VMT
(VA; metamorphopsia)
• Patients who would benefit from PPV
• Understand the procedure and sign the consent form
Exclusion• ERM
• MH
• Predisposing to RRD peripheral retinal lesions
• OHT (± glaucoma)
• Patients about to travel by air
Outcome Measures
Primary
number of eyes with complete
VMT release on SD-OCT :
- within 1 month following treatment (absolute success)
- > 1 month following treatment (qualified success)
Secondary
changes in:
- VA
- foveal contour
- central foveal thickness(built-in ETDRS subfield 1)
- maximal foveal thickness(built-in software calipers)
AE’s documentation
Maximal Horizontal VMT LengthCentealFoveal Thickness
Maximal Foveal Thickness
Results
Demographics
• 8 male (53%)
• 9 Caucasian / 3 Afro-Caribbean / 2 Asian
• Mean age: 72.1 ± 12.6 years (range: 38-89)
• Mean VMT duration: 328.1 ± 250.9 days (range: 91-658)
• Diagnosis: - 7 idiopathic
- 6 DME
- 1 imp. MH
- 1 wAMD
Results
Primary Outcome
• Absolute success: 6 eyes (40%)
• Qualified success: 3 eyes (20%)
Documented between 1 and 6 months after treatment
• Overall success: 9 eyes (60%)
Results
Secondary Outcome
Baseline1 Month Following
TreatmentFinal Visit
Mean VA± SD (LogMAR)
0.52 ± 0.28 0.64 ± 0.45 P=0.15 0.49 ± 0.27 P=0.54
Mean MFT± SD(μm) 491.1 ±212.5
425. 3 ± 210.8 P=0.04349.9 ±242.3
P=0.0001
Mean CFT± SD(μm) 394.3 ±146.5
391.3 ± 181.3 P=0.89 378.3 ± 182 P=0.57
Results
Successful Case
Baseline
Month-1 Visit
Results
Failed Case
Baseline
Month-1 Visit
Results
Complicated Case
Baseline
Month-1 Visit
Results
Responders’ Analysis
Absolute Success Failure p
Mean Maximal HorizontalVMT Length ± SD(μm)
334.2 ± 81.7 696.2 ± 113.6 P=0.037
Mean MFT± SD(μm)383.9 ± 63.1 652.0 ± 261.4 P=0.010
Results
Responders’ Analysis
• 75% of eyes with < 750μm Horizontal VMT Length had complete VMT release (p=0.018)
• 82% of eyes with < 500μmMaximal Foveal Thickness had complete VMT release (p=0.004)
Complications
• 1 eye progressed from impeding MH to FTMH within a
1/12 from treatment had PPV/ILM peel/gas
• 1 eye with spontaneously resolved VH 3/12 post treatment (PDR-related)
Discussion
• Pneumatic vitreolysis (40%) appears NOT to be inferior to microplasminvitreolysis (26.5%)
• C3F8 has a good safety profile
• C3F8 is globally available
• Can be offered as an office-based procedure
Conclusion
Intravitreal C3F8 injection for persistent & symptomatic VMT…
• Is a minimally invasive treatment modality
• Appears to be safe
• Can release VMT in < 750μm Horizontal VMT Length and/or < 500μm MFT
• Can reduce the burden of cost