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IOL Opacification R. Khoramnia [email protected] www.ivcrc.com www.djapplelab.com International Vision Correction Research Centre (IVCRC) The David J. Apple International Laboratory for Ocular Pathology Department of Ophthalmology Ruprecht-Karls-University of Heidelberg Chairman: G. U. Auffarth, MD, PhD, FEBO

IOL Opacification - EFCLIN...Khoramnia R, Salgado JP, Auffarth GU, Schmidt S, Wegner A, Kobuch KA, Winkler von Mohrenfels C. Ophthalmologe. 2012 May;109(5):483-6. University Eye Clinic

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IOL OpacificationR. Khoramnia

[email protected] www.ivcrc.com www.djapplelab.com

International Vision Correction Research Centre (IVCRC)The David J. Apple International Laboratory for Ocular Pathology Department of OphthalmologyRuprecht-Karls-University of HeidelbergChairman: G. U. Auffarth, MD, PhD, FEBO

University Eye Clinic Heidelberg

IVCRC / DJ Apple Laboratory: Financial Disclosures 2018/2019

1 = Research Grants; 2 = Travel Expenses; 3 = Lecture Fees; 4 = Consulting

Acufocus1

Alcon/Novartis1,2,3,4

Alimera1,2

AMO/Johnson&Johnson1,2,3,4

Bausch+Lomb2,3

SIFI3Carl Zeiss Meditec1,2,3

Contamac1

Glaukos1

Hoya1,2,3

Kowa1,2,3

Oculentis1,2,3

Oculus1,2,3

Physiol1Presbia2,3,4

Rayner1,2,3

Santen1

SIFI1,2,3

Ursapharm1,2,3

University Eye Clinic Heidelberg

David J. Apple Laboratory

Analysis of explanted IOLs, Biomaterial analysis of new IOLs,

Analysis of the optical quality of IOLs

University Eye Clinic Heidelberg

Classification of Calcification: Neuhann et al. 1) Primary Calcification

• Calcification that is inherent in the IOL

• In otherwise normal eyes and not associated with

preexisting diseases

• Due to a material defect or problem during the

manufacturing process of the lens

2) Secondary Calcification

• Not related to any problem with the IOL itself

• Result of environmental circumstances (e.g., changes in the

aqueous milieu surrounding the implanted IOL associated

with preexisting or concurrent diseases or indeed any

condition that has disrupted the blood-aqueous barrier)

3) False-positive or Pseudocalcification

• Other pathology is mistaken for calcification or false-positive

staining for calcium occurs

University Eye Clinic Heidelberg

Opcacification of hydrophilic acrylic IOLs

University Eye Clinic Heidelberg

Classification of Calcification: Neuhann et al. 1) Primary Calcification

• Calcification that is inherent in the IOL

• In otherwise normal eyes and not associated with

preexisting diseases

• Due to a material defect or problem during the

manufacturing process of the lens

2) Secondary Calcification

• Not related to any problem with the IOL itself

• Result of environmental circumstances (e.g., changes in the

aqueous milieu surrounding the implanted IOL associated

with preexisting or concurrent diseases or indeed any

condition that has disrupted the blood-aqueous barrier)

3) False-positive or Pseudocalcification

• Other pathology is mistaken for calcification or false-positive

staining for calcium occurs

University Eye Clinic Heidelberg

Opacified hydrophilic IOL: Aquasense

*[Opacification of a hydrophilic intraocular lens 4 years after cataract surgery. A biomaterial analysis]. Khoramnia R, Salgado JP, Auffarth GU, Schmidt S, Wegner A, Kobuch KA, Winkler von Mohrenfels C. Ophthalmologe. 2012 May;109(5):483-6.

University Eye Clinic Heidelberg

Opacified hydrophilic IOL: Euromaxx (Argonoptics)*

*Tandogan T, Khoramnia R, Choi CY, Scheuerle A, Wenzel M, Hugger P, Auffarth GU. Optical and material analysis of opacified hydrophilicintraocular lenses after explantation: a laboratory study. BMC Ophthalmol. 2015 Nov 25;15:170. doi: 10.1186/s12886-015-0149-1.

University Eye Clinic Heidelberg

Opacified hydrophilic IOL: Euromaxx (Argonoptics)*

Light and scanning electron microscopy as well as X-ray spectroscopy in opacified Euromaxx ALI313Y and ALI313 IOLs

*Tandogan T, Khoramnia R, Choi CY, Scheuerle A, Wenzel M, Hugger P, Auffarth GU.Optical and material analysis of opacified hydrophilicintraocular lenses after explantation: a laboratory study. BMC Ophthalmol. 2015 Nov 25;15:170. doi: 10.1186/s12886-015-0149-1.

University Eye Clinic Heidelberg

Material & Methods*− Explantation of 6 IOLs (Euromaxx ALI313Y and ALI313) that had opacified

− Light microscopy: Staining with Alizarin red and von Kossa

− Scanning electron microscopy

− X-ray spectroscopy (EDX): Chemical composition of the deposits

− Optical bench (OptiSpheric, Trioptics): Optical quality assessment

*Tandogan T, Khoramnia R, Choi CY, Scheuerle A, Wenzel M, Hugger P, Auffarth GU.Optical and material analysis of opacified hydrophilic intraocular lenses after explantation: a laboratory study. BMC Ophthalmol. 2015 Nov 25;15:170. doi: 10.1186/s12886-015-0149-1.

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Results – Gross examination*

*Tandogan T, Khoramnia R, Choi CY, Scheuerle A, Wenzel M, Hugger P, Auffarth GU.Optical and material analysis of opacified hydrophilic intraocular lenses after explantation: a laboratory study. BMC Ophthalmol. 2015 Nov 25;15:170. doi: 10.1186/s12886-015-0149-1.

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Results – Light microscopy*Staining with Alizarin red

*Tandogan T, Khoramnia R, Choi CY, Scheuerle A, Wenzel M, Hugger P, Auffarth GU.Optical and material analysis of opacified hydrophilic intraocular lenses after explantation: a laboratorystudy. BMC Ophthalmol. 2015 Nov 25;15:170. doi: 10.1186/s12886-015-0149-1.

University Eye Clinic Heidelberg

Von Kossa Staining

*Tandogan T, Khoramnia R, Choi CY, Scheuerle A, Wenzel M, Hugger P, Auffarth GU.Optical and material analysis of opacified hydrophilic intraocular lenses after explantation: a laboratorystudy. BMC Ophthalmol. 2015 Nov 25;15:170. doi: 10.1186/s12886-015-0149-1.

Results – Light microscopy*

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Results – Scanning electron microscopy*

*Tandogan T, Khoramnia R, Choi CY, Scheuerle A, Wenzel M, Hugger P, Auffarth GU.Optical and material analysis of opacified hydrophilic intraocular lenses after explantation: a laboratorystudy. BMC Ophthalmol. 2015 Nov 25;15:170. doi: 10.1186/s12886-015-0149-1.

University Eye Clinic Heidelberg

Results – EDX*Energy dispersive X-ray spectroscopy (EDX)

Calcium phosphate*Tandogan T, Khoramnia R, Choi CY, Scheuerle A, Wenzel M, Hugger P, Auffarth GU. Optical and material analysis of opacified hydrophilic intraocular lenses after explantation: a laboratorystudy. BMC Ophthalmol. 2015 Nov 25;15:170. doi: 10.1186/s12886-015-0149-1.

University Eye Clinic Heidelberg

Results – Element Mapping*

*Tandogan T, Khoramnia R, Choi CY, Scheuerle A, Wenzel M, Hugger P, Auffarth GU.Optical and material analysis of opacified hydrophilic intraocular lenses after explantation: a laboratorystudy. BMC Ophthalmol. 2015 Nov 25;15:170. doi: 10.1186/s12886-015-0149-1.

University Eye Clinic Heidelberg

Results – Optical Bench*Modulation Transfer Function (MTF)

Severe reduction of optical quality*Tandogan T, Khoramnia R, Choi CY, Scheuerle A, Wenzel M, Hugger P, Auffarth GU.Optical and material analysis of opacified hydrophilic intraocular lenses after explantation: a laboratorystudy. BMC Ophthalmol. 2015 Nov 25;15:170. doi: 10.1186/s12886-015-0149-1.

University Eye Clinic Heidelberg

Report to the authorities

University Eye Clinic Heidelberg

Recall of IOL

University Eye Clinic Heidelberg

Classification of Calcification: Neuhann et al. 1) Primary Calcification

• Calcification that is inherent in the IOL

• In otherwise normal eyes and not associated with

preexisting diseases

• Due to a material defect or problem during the

manufacturing process of the lens

2) Secondary Calcification

• Not related to any problem with the IOL itself

• Result of environmental circumstances (e.g., changes in

the aqueous milieu surrounding the implanted IOL

associated with preexisting or concurrent diseases or

indeed any condition that has disrupted the blood-

aqueous barrier)

3) False-positive or Pseudocalcification

• Other pathology is mistaken for calcification or false-positive

staining for calcium occurs

University Eye Clinic Heidelberg

IOL Opacification following Intracameral Injection of rtPA to Treat Inflammatory Membranes after Cataract Surgery

*Intraocular Lens Opacification following Intracameral Injection of Recombinant Tissue Plasminogen Activator to Treat Inflammatory Membranes after Cataract Surgery. Fung SS, Sykakis E, Islam NM, Zambarakji HJ, Khoramnia R, Auffarth GU, Parmar DN. J Ophthalmol. 2015;2015:975075. doi: 10.1155/2015/975075.

University Eye Clinic Heidelberg

*Intraocular Lens Opacification following Intracameral Injection of Recombinant Tissue Plasminogen Activator to Treat Inflammatory Membranes after Cataract Surgery. Fung SS, Sykakis E, Islam NM, Zambarakji HJ, Khoramnia R, Auffarth GU, Parmar DN. J Ophthalmol. 2015;2015:975075. doi: 10.1155/2015/975075.

IOL Opacification following Intracameral Injection of rtPA to Treat Inflammatory Membranes after Cataract Surgery

University Eye Clinic Heidelberg

Hydrophilic intraocular lens opacificationafter posterior lamellar keratoplasty*

*Giers BC, Tandogan T, Auffarth GU, Choi CY, Auerbach FN, Sel S, Mayer C, Khoramnia R. Hydrophilic intraocular lens opacification after posterior lamellar keratoplasty - a material analysiswith special reference to optical quality assessment. BMC Ophthalmol. 2017 Aug 22;17(1):150. doi: 10.1186/s12886-017-0546-8.

University Eye Clinic Heidelberg

*Giers BC, Tandogan T, Auffarth GU, Choi CY, Auerbach FN, Sel S, Mayer C, Khoramnia R. Hydrophilic intraocular lens opacification after posterior lamellar keratoplasty - a material analysiswith special reference to optical quality assessment. BMC Ophthalmol. 2017 Aug 22;17(1):150. doi: 10.1186/s12886-017-0546-8.

Hydrophilic IOL opacification after posterior lamellar keratoplasty*

University Eye Clinic Heidelberg

Light microscopy*

*Giers BC, Tandogan T, Auffarth GU, Choi CY, Auerbach FN, Sel S, Mayer C, Khoramnia R. Hydrophilic intraocular lens opacification after posterior lamellar keratoplasty - a material analysiswith special reference to optical quality assessment. BMC Ophthalmol. 2017 Aug 22;17(1):150. doi: 10.1186/s12886-017-0546-8.

University Eye Clinic Heidelberg

*Giers BC, Tandogan T, Auffarth GU, Choi CY, Auerbach FN, Sel S, Mayer C, Khoramnia R. Hydrophilic intraocular lens opacification after posterior lamellar keratoplasty - a material analysiswith special reference to optical quality assessment. BMC Ophthalmol. 2017 Aug 22;17(1):150. doi: 10.1186/s12886-017-0546-8.

Light microscopy*

University Eye Clinic Heidelberg

Scanning electron microscopy*

*Giers BC, Tandogan T, Auffarth GU, Choi CY, Auerbach FN, Sel S, Mayer C, Khoramnia R. Hydrophilic intraocular lens opacification after posterior lamellar keratoplasty - a material analysiswith special reference to optical quality assessment. BMC Ophthalmol. 2017 Aug 22;17(1):150. doi: 10.1186/s12886-017-0546-8.

University Eye Clinic Heidelberg

Element Mapping*

*Giers BC, Tandogan T, Auffarth GU, Choi CY, Auerbach FN, Sel S, Mayer C, Khoramnia R. Hydrophilic intraocular lens opacification after posterior lamellar keratoplasty - a material analysiswith special reference to optical quality assessment. BMC Ophthalmol. 2017 Aug 22;17(1):150. doi: 10.1186/s12886-017-0546-8.

University Eye Clinic Heidelberg

EDX*

*Giers BC, Tandogan T, Auffarth GU, Choi CY, Auerbach FN, Sel S, Mayer C, Khoramnia R. Hydrophilic intraocular lens opacification after posterior lamellar keratoplasty - a material analysiswith special reference to optical quality assessment. BMC Ophthalmol. 2017 Aug 22;17(1):150. doi: 10.1186/s12886-017-0546-8.

University Eye Clinic Heidelberg

Optical quality*

*Giers BC, Tandogan T, Auffarth GU, Choi CY, Auerbach FN, Sel S, Mayer C, Khoramnia R. Hydrophilic intraocular lens opacification after posterior lamellar keratoplasty - a material analysiswith special reference to optical quality assessment. BMC Ophthalmol. 2017 Aug 22;17(1):150. doi: 10.1186/s12886-017-0546-8.

University Eye Clinic Heidelberg

Hydrophilic IOL opacification after posterior lamellar keratoplasty: Straylight*

*Assessment of straylight and the modulation transfer function of intraocular lenses with centrally localized opacification associated with the intraocular injection of gas. Łabuz G, Yildirim TM, van den Berg TJTP, Khoramnia R, Auffarth GU. J Cataract Refract Surg. 2018 May;44(5):615-622.

Severeincrease of straylight

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Hydrophilic IOL opacification after PpV*

*Material Analysis and Optical Quality Assessment of Opacified Hydrophilic Acrylic Intraocular Lenses after Pars Plana Vitrectomy. Yildirim TM, Auffarth GU, Łabuz G, Bopp S, Son HS, Khoramnia R. Am J Ophthalmol. 2018 Sep;193:10-19.

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Hydrophilic IOL opacification after PpV*

*Material Analysis and Optical Quality Assessment of Opacified Hydrophilic Acrylic Intraocular Lenses after Pars Plana Vitrectomy. Yildirim TM, Auffarth GU, Łabuz G, Bopp S, Son HS, Khoramnia R. Am J Ophthalmol. 2018 Sep;193:10-19.

University Eye Clinic Heidelberg

*Opacification of hydrophilic intraocular lenses associated with vitrectomy and injection of intraocular gas. Marcovich AL, Tandogan T, Bareket M, Etting E, Kaplan-Ashiri I, Bukelman A, Auffarth GU, Khoramnia R. BMJ Open Ophthalmol. 2018 Dec 15;3(1):e000157.

Hydrophilic IOL opacification after PpV*

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Hydrophilic IOL opacification after PpV*

*Opacification of hydrophilic intraocular lenses associated with vitrectomy and injection of intraocular gas. Marcovich AL, Tandogan T, Bareket M, Etting E, Kaplan-Ashiri I, Bukelman A, Auffarth GU, Khoramnia R. BMJ Open Ophthalmol. 2018 Dec 15;3(1):e000157.

University Eye Clinic Heidelberg

Hydrophilic IOL opacification after PpV*

*Opacification of hydrophilic intraocular lenses associated with vitrectomy and injection of intraocular gas. Marcovich AL, Tandogan T, Bareket M, Etting E, Kaplan-Ashiri I, Bukelman A, Auffarth GU, Khoramnia R. BMJ Open Ophthalmol. 2018 Dec 15;3(1):e000157.

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Opacification of hydrophilic intraocular lens after multiple injections of bevacizumab*

*Opacification of hydrophilic intraocular lens after multiple injections of bevacizumab. Roland S., Khoramnia R., Auffarth G.U., Son H.-S., Yildirim T.M., Schoenherr U. In press

University Eye Clinic Heidelberg

Classification of Calcification: Neuhann et al. 1) Primary Calcification

• Calcification that is inherent in the IOL

• In otherwise normal eyes and not associated with

preexisting diseases

• Due to a material defect or problem during the

manufacturing process of the lens

2) Secondary Calcification

• Not related to any problem with the IOL itself

• Result of environmental circumstances (e.g., changes in the

aqueous milieu surrounding the implanted IOL associated

with preexisting or concurrent diseases or indeed any

condition that has disrupted the blood-aqueous barrier)

3) False-positive or Pseudocalcification

• Other pathology is mistaken for calcification or false-

positive staining for calcium occurs

University Eye Clinic Heidelberg

Liquefied Aftercataract*

*Giers BC, Khoramnia R, Tandogan T, Auffarth GU. Liquefied Aftercataract Mimicking IOL-Opacification. Klin Monbl Augenheilkd. 2017 Aug;234(8):988-990.

University Eye Clinic Heidelberg

Summary• In addition to good optical quality, material properties are important in IOLs.

• In contrast to IOLs from hydrophobic acrylic, IOLs made of hydrophilic material can calcify.

• Primary Calcification: Production errors may be responsible for IOL calcification (e.g. Aquasense and Euromaxx).

• Secondary Calcification: IOLs made of hydrophilic acrylic can opacify irrespective of themanufacturer during various interventions (e.g. posterior lamellar keratoplasty, rtPAinjection, PpV).

• IOL exchange in symptomatic patients is the only treatment option available. Since IOL exchange is associated with a high intraoperative complication rate, our results suggest to consider the risk of IOL calcification when implanting hydrophilic acrylic IOLs.

Thank you!