meta analysis and revie · 2019-01-07 · well established benefits myopia significantly impacts...

Meta Analysis and

ReviewEFFECTIVENESS, SAFETY AND CENTRAL PORT DESIGN OF THE

INTRAOCULAR COLLAMER LENS

Mark Packer MD

Well Established Benefits

Myopia significantly impacts Quality of Life1

Authors found the adverse effect of higher degrees of

myopia is comparable to that of keratoconus

After Visian ICL™ Surgery:

High Patient Satisfaction (> 99% @ 12, 24 and 36 months

postoperative)2

Significant Improvement in Quality of Life (p < 0.001)3

1. Rose K, Harper R, Tromans C, Waterman C, Goldberg D, Haggerty C, Tullo A. Quality of life in myopia. Br J Ophthalmol. 2000 Sep;84(9):1031-4.2. MICL PMA Data3. Ieong A, Hau, S, Rubin GS, Alan B. Quality of Life in High Myopia before and after Implantable Collamer Lens Implantation. Ophthalmology 2010; 117:2295-2300.

Quality of life Impact of Refractive Correction

Ieong A, Hau, S, Rubin GS, Alan B. Quality of Life in High Myopia before and after Implantable Collamer Lens Implantation. Ophthalmology 2010; 117:2295-2300.

• Initial study: Visian ICL™ recipients and established contact lens wearers

• QIRC Total Score (Ieong, et al): Quality of Life Impact of

Refractive Correction (QIRC)

Pre-ICL: 40.45 ± 4.83 Post-ICL: 53.79 ± 5.60 (p < 0.001)

• Superior quality of life for ICL recipients with significant gains across a range of activities compared with symptom-free, well adapted contact lens wearers

Effectiveness

Efficacy Index: 0.96 – 1.031, 2, 3

Seeing well “right off the table”5

Long-term refractive stability4

1. Efficacy Index = Postoperative UCVA / Preoperative BCVA

2. Lisa C, Alfonso JF, Alfonso-Bartolozzi B, Fernández-Vega L, Pérez-Vives C, Montés-Micó R. Collagen copolymer posterior chamber phakic intraocular lens supported by the ciliary sulcus

to treat myopia: one-year follow-up. J Cataract Refract Surg. 2015 Jan;41(1):98-104.

3. Huseynova T, Ozaki S, Ishizuka T, Mita M, Tomita M. Comparative study of 2 types of implantable collamer lenses, 1 with and 1 without a central artificial hole. Am J Ophthalmol. 2014

Jun;157(6):1136-43.

4. Shimizu K, Kamiya K, Igarashi A, Kobashi H. Long-Term Comparison of Posterior Chamber Phakic Intraocular Lens With and Without a Central Hole (Hole ICL and Conventional ICL)

Implantation for Moderate to High Myopia and Myopic Astigmatism. Medicine. 2016 Apr;95(14):e3270.

5. Steven S. Lane, MD, quoted in Helzner J, Phakic IOLs: Ready for a Breakthrough? Ophthalmology Management March 1, 2011.

http://www.ophthalmologymanagement.com/articleviewer.aspx?articleid=105346 (Accessed August 6, 2016).

http://www.ophthalmologymanagement.com/articleviewer.aspx?articleid=105346

Safety

Safety concerns

Elevated IOP

Cataract

Multiple etiologies

Patient

Surgeon

ICL (vault)

ICL4

• Excessive vault (>1000 µm)

• Angle crowding to angle closure

• Iris chaffing and pigment dispersion

Etiologies of Elevated IOP

Patient1

Age2

Myopia2,3,7,8

History of ocular trauma

Chronic iritis/Steroid response

Gonioscopy

Narrow angles

Iris configuration

Pigment dispersion syndrome (young, myopic males)2

1. Chen et al. Metaanalysis of cataract development after PIOL surgery. J Cataract Refract Surg 2008; 34:1181–1200.

2. Chun et al. iris and trabecular meshwork pigment changes after posterior chamber phakic IOL implantation. J Cataract Refract surg 2006; 32:1452-1458.

3. Xu L, Wang Y, Wang S, et al. High myopia and glaucoma susceptibility the Beijing Eye Study. Ophthalmology 2007;114:216–20.

4. Choi et al. Ultrasound biomocroscopy for determining Visian Icl length in phakic IOL implantation. J Refract Surg. 2007; 23:362-367.

5. Esteban et al. IOP after implantation of Visian ICL with CentraFLOW without iridotomy. Am J Ophthalmol 2013; 156:800-805.

6. McCaughey et al. Pseudophacomorphic glaucoma along with pupillary block after Visian ICL implantation in High Myopia. Open Journal of Ophthalmology. 4, 107-111

7. Wu SY, Nemesure B, Leske MC. Glaucoma and myopia. Ophthalmology 2000 Jun; 107(6):1026-7.

8. Ponte F, Giuffre G, Giammanco R, Dardanoni G. Risk Factors of ocular hypertension and glaucoma. The Casteldaccia Eye Study. Ophthalmol 1994; 85(3):203-10.

Surgeon

• Inadequate preoperative iridotomies1,2,5,6

• Careful and thorough removal of viscoelastic

ICL1

- Insufficient Vault2,4,5

• Disturbance of aqueous flow1

• Interference with lens metabolism1

Etiologies of Cataract

Patient1

Age2,3

Refractive status3

Direct or indirect ocular trauma

Clinical inflammatory reaction

Iritis and topical steroids

Preexisting opacities

1. Chen et al. Metaanalysis of cataract development after PIOL surgery. J Cataract Refract Surg 2008; 34:1181–1200.2. Gonvers et al. Implantable contact lens for moderate to high myopia: relationship of vaulting to cataract formation. J Cataract Refract Surg 2003; 29: 918–

243. Sanders DR. Anterior subcapsular opacities and cataracts 5 years after surgery in the visian implantable collamer lens FDA trial. J Refract Surg. 2008

Jun;24(6):566-704. Schmidinger et al. Long-term changes in posterior chamber phakic intraocular Collamer lens vaulting in myopic patients. Ophthalmology 2010; 117:1506–

15115. Alfonso et al, Central vault after phakic intraocular lens implantation: Correlation with anterior chamber depth, white-to-white distance, spherical

equivalent, and patient age J Cataract Refract Surg 2012; 38:46–53

Surgeon1

• Surgical trauma

• Early onset (< 3M) associated with surgical trauma

• Iridectomy or Nd:YAG

• Surgeon learning curve and individual surgeon variability

ICL Sizing Methods

White to White (WTW) with calipers or topography

Simple, inexpensive, easy to measure with available

equipment

Surrogate anatomical landmark

Sulcus to Sulcus (STS) measurement with UBM

Only device to measure sulcus directly

Variable measurements, operator dependent

Angle to Angle (ATA), Iris Pigment (PTP) with OCT

OCT is widely used

Surrogate anatomical landmark

Parameters of Vault

Adequate vault range 90 to 1,000 microns1,2

Ideal vault range 250 – 750 microns4

Weak correlation between WTW and STS values2,3

1. Gonvers M, Bornet C, Othein-Girard P. Implantable Contact Lens for Moderate to High Myopia; relationship of vaulting to cataract formation. J Cataract Refract Surg 2003; 29:918-924

2. Dougherty PJ, Rivera RP, Schnieder D, Lane SS, Brown D, Vukich J. Improving accuracy of phakic intraocular lens sizing using high-frequency ultrasound biomicroscopy. J Cataract Refract Surg 2010; 37: 13-18.

3. Reinstein DZ, Archer TJ, Silverman RH, Rondeau MJ, Coleman DJ. Correlation of anterior chamber angle and ciliary sulcus diameters with white-to-white corneal diameter in high myopes using Artemis VHF digital ultrasound. J Refract Surg 2009; 25: 185-194.

4. Alfonso JF, Fernandez-Vega, L, Lisa C, Fernandes P, Jorge J, Montes-Mico R. Central Vault after phakic intraocular lens implantation: Correlation with anterior chamber depth, white-to-white distance, spherical equivalent, and patient age. J Cataract Refract Surg 2012; 38:46-53

Studies with objective

measurement of vault

Method N (eyes) Means μm SDs μm Min μm Max μm

WTW/ACD

2,392 322 to 594 141 to 268 0 1300

STS 204 370 to 640 160 to 250 80 1330

Analysis of Vault by Sizing Method

95% CIs fall within guidelines for safe vault

Analysis of Vault by Sizing Method

Improving Safety

Mitigation

Patient selection, surgeon experience & skill

ICL

Vault is statistically the same regardless of sizing methodology

Variability of vault is a result of multiple factors

A small number of outliers occurs regardless of sizing methodology

EVO

Vault is statistically the same as ICL

Data suggest improved safety

Not approved in the US

EVO Visian ICL™ Peer-Reviewed Literature


EVO Visian ICL™ Peer-Reviewed Literature

No difference in vault


EVO Effectiveness

69 – 100% UCVA 20/20 or better1,2,3

Efficacy Index 1.00 – 1.031,2,3,4

75 – 98.5% within ± 0.50 D MRSE1,2,4

Excellent refractive stability1

1. Lisa C, Naveiras M, Alfonso-Bartolozzi B, Belda-Salmerón L, Montés-Micó R, Alfonso JF. Posterior chamber collagen copolymer phakic intraocular lens with a central hole to correct myopia: One-year follow-up. J

Cataract Refract Surg. 2015 Jun;41(6):1153-9

2. Alfonso JF, Lisa C, Fernández-Vega Cueto L, Belda-Salmerón L, Madrid-Costa D, Montés-Micó R. Clinical outcomes after implantation of a posterior chamber collagen copolymer phakic intraocular lens with a

central hole for myopic correction. J Cataract Refract Surg. 2013 Jun;39(6):915-21.

3. Shimizu K, Kamiya K, Igarashi A, Shiratani T. Early clinical outcomes of implantation of posterior chamber phakic intraocular lens with a central hole (Hole ICL) for moderate to high myopia. Br J Ophthalmol. 2012

Mar;96(3):409-12.

4. Huseynova T, Ozaki S, Ishizuka T, Mita M, Tomita M. Comparative study of 2 types of implantable collamer lenses, 1 with and 1 without a central artificial hole. Am J Ophthalmol. 2014 Jun;157(6):1136-43.


EVO Quality of Vision

Prospective studies1, 2 have been conducted

comparing outcomes between subjects implanted

with V4c (EVO) and V4b (ICL without central hole):

Higher Order Aberrations (HOAs)

Contrast Sensitivity (photopic, mesopic and mesopic with

glare)

Subjective Symptoms (glare, halo)

Quality of vision was equivalent between the V4c (EVO) and V4b

(ICL without central hole) models

1. Shimizu K, Kamiya K, Igarashi A, Shiratani T. Intraindividual comparison of visual performance after posterior chamber phakic intraocular lens with and without a central hole implantation for moderate to high

myopia. Am J Ophthalmol. 2012 Sep;154(3):486-494.

2. Kamiya K, Shimizu K, Saito A, Igarashi A, Kobashi H. Comparison of optical quality and intraocular scattering after posterior chamber phakic intraocular lens with and without a central hole (Hole ICL and

Conventional ICL) implantation using the double-pass instrument. PLoS One. 2013 Jun 25;8(6):e66846.


EVO Safety


EVO IOP well controlled


Conventional ICL vs. EVO1 (5 year follow-up)

Prospective, randomized, contralateral control study to

compare long-term (5 years) clinical outcomes in eyes

implanted with ICLs with and without a central hole.

64 eyes of 32 patients, Hole ICL in one eye, Conventional ICL in

other eye.

1. Shimizu K, Kamiya K, Igarashi A, Kobashi H. Long-Term Comparison of Posterior Chamber Phakic Intraocular Lens With and Without a Central Hole (Hole ICL and Conventional ICL) Implantation for Moderate to High Myopia and Myopic Astigmatism. Medicine. 2016 Apr;95(14):e3270.



Safety


Endothelial Cell Density IOP Adverse Events

ICL EVO

ASC 1 (3.1%) 0

SSI 2 (6.2%) 0TICL Rotation 1

PRK 1


EVO Safety


Conclusions - Safety

Vault is essentially the same and adverse events are few regardless of

sizing methodology.

Variations in vault per se are not adverse events.

Vault is essentially the same with ICL and EVO; however, data suggest

even fewer adverse events with EVO.

Conclusions - Effectiveness

The refractive efficacy of ICL is unparalleled.

These are our very happiest patients.

Thank you!

meta analysis and revie · 2019-01-07 · well established benefits myopia significantly impacts...

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