CLINICAL FOCUS
Dead Bag Syndrome
Insights from the Intermountain Ocular Research Center
2023
JOHN A . M OR AN EYE CENTER
JULY 1 , 2022 — JUN E 30 , 2023
Moran Eye Center at a Glance RESEARCH GRANTS
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$11 Million
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Cornea/Refractive: 19,347
2023-2024 Best Hospitals for Ophthalmology No. 10 Nationwide
Retina: 23,830
Uveitis: 4,918 Comprehensive / Cataract: 19,971 Oculoplastic: 7,276
174 , 5 6 5 T O TA L PAT IE N T V ISI T S
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By Specialty
Other: 20,376 Pediatric: 16,178
Low Vision: 412 Optometry: 36,737
Best Overall Program No. 12 Nationwide
Glaucoma: 21,006 Neuro-Ophthalmology: 4,514
SUR GER IE S P ER F OR MED : 8,618 By Specialty
2023 Residency Education No. 6 Nationwide No. 1 in the West
• Cataract/Lens Extractions – 4,419 • Pediatric – 1,259 • Retina – 809 • Oculoplastic – 746 • Glaucoma – 605 • Cornea – 248 • Other – 532
CATA R AC T SUR GERY OU T C OME S In 2022, only 1% of cataract surgeries at Moran Eye Center clinics involved complications. Scan the QR code to view our latest outcomes data.
ON THE COVER
Ophthalmic imaging of patients with dead bag syndrome shows IOLs dislocated in the capsular bags. The capsular bags look quite clear, a hallmark of the syndrome.
ME S S AGE F R OM T HE CH A IR
A Commitment to EvidenceBased Best Practices At the Intermountain Ocular Research Center at the John A. Moran Eye Center, Nick Mamalis, MD, and Liliana Werner, MD, PhD, are in the business of solving mysteries. Assisting industry and physicians across the globe, their research on intraocular lens (IOL) design, materials, and complications has shaped anterior segment surgery as we know it, not to mention improved outcomes for millions of patients undergoing cataract and other procedures each year. IOL advances over the past decade have been particularly exciting. We’ve seen the lightadjustable IOL join the U.S. market, and research is moving forward on a laser procedure that would allow lens power adjustment following surgery. Yet we’ve also faced new quandaries, such as dead bag syndrome, first described by Samuel Masket, MD. This elusive complication occurs years after successful routine cataract surgeries when the capsular bag fails to retain its shape, causing IOL dislocation. The cause is unknown, but hopefully not for long. Dr. Olson specializes in research dealing with intraocular lens and cataract surgery. He is the author of more than 300 professional publications and has given many named lectures all over the U.S. and worldwide. In his clinical practice, Dr. Olson specializes in cataract services and external eye diseases.
Working with colleagues across the country, including Dr. Masket, Drs. Mamalis and Werner are zeroing in on potential causes using histopathologic and immunohistochemical analysis. They have presented on dead bag syndrome in detail at the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology annual meetings and created an award-winning film to share their work. I hope this edition of Clinical FOCUS brings you up to speed on what is known about this possible complication. Understanding prognosis and repair options are essential as we continue to pursue successful long-term outcomes for our patients. Moran’s Austin Nakatsuka, MD, and Katherine Hu, MD, have experience with a dead bag case and share their insights into clinical management. Finally, don’t miss this edition’s update on the effectiveness of open/expanded-bag cataract surgery techniques in preventing posterior capsule opacification. We are committed to delivering the best evidence-based practices this top-of-field research can provide. Sincerely,
Randall J Olson, MD Distinguished Professor and Chair, Department of Ophthalmology and Visual Sciences, University of Utah The Cumming Presidential Endowed Chair CEO, John A. Moran Eye Center Director, University of Utah Vision Institute
Nick Mamalis, MD, and Liliana Werner, MD, PhD, direct the Intermountain Ocular Research Center.
About the Intermountain Ocular Research Center
Unraveling the Mysteries of Dead Bag Syndrome
Established in 1982 and currently directed by Liliana Werner, MD, PhD, and Nick Mamalis, MD, this nonprofit, independent laboratory based at the Moran Eye Center performs basic, in-depth research on intraocular lenses. The center provides services and education for surgeons, clinical ophthalmologists, their patients, and manufacturers. More than 1,000 peerreviewed publications from the center guide companies and physicians worldwide as the center vets new lens technology. The center also is involved in the analysis of Toxic Anterior Segment Syndrome (TASS) and other causes of postoperative inflammation following cataract surgery.
By Liliana Werner, MD, PhD, and Nick Mamalis, MD Since the early 2000s, ophthalmologists have been reporting something mysterious in their practices: patients—years after their routine cataract surgeries—presenting with dislocated intraocular lenses (IOLs). In these cases, the capsular bag appeared to be clear and had become diaphanous and floppy—unable to support the IOL within it. Samuel Masket, MD, a surgeon and clinical researcher in Los Angeles, first observed the condition and coined the term “dead bag syndrome” to describe it. Until then, pseudoexfoliation syndrome, uveitis, myopia, and pars plana vitrectomy were the main conditions associated with progressive zonular weakening and late postoperative in-the-bag IOL dislocation.1 These conditions did not appear to be a factor in the patients with suspected dead bag syndrome. At the Intermountain Ocular Research Center at the Moran Eye Center, we have dedicated significant resources to studying dead bag syndrome, including a collaboration with Dr. Masket and others in 2022 to publish the first formal, peer-reviewed study of the condition.2 Dr. Werner is co-director of the Intermountain Ocular Research Center and Moran’s vice-chair for equity, diversity, and inclusion. She is recognized as a foremost authority in the IOL field and was the first woman to receive the prestigious American Academy of Ophthalmology’s Charles D. Kelman Award and Lecture. She is also the first woman and the first Latina to hold the position of U.S. Associate Editor for the Journal of Cataract & Refractive Surgery. Dr. Werner holds the Ralph and Mary Tuck Presidential Endowed Chair at the University of Utah Department of Ophthalmology and Visual Sciences.
Dr. Mamalis directs Moran’s Ophthalmic Pathology Laboratory and is a renowned expert on intraocular lenses as co-director of the Intermountain Ocular Research Center. He is a past president of the American Society of Cataract and Refractive Surgery (ASCRS) and has received the American Academy of Ophthalmology Life Achievement Honor Award, among others. He is the holder of the Calvin S. and JeNeal N. Hatch Presidential Endowed Chair at the University of Utah Department of Ophthalmology and Visual Sciences. In his clinical practice, Dr. Mamalis specializes in cataract and other anterior ocular surgeries.
A
B
C
D
E
F
Slit lamp photographs of suspected dead bag syndrome cases show remarkably clear capsules. In some cases, the IOL appears to be decentered inside of the bag (A, B, C, and F). In others, the capsular bag also appears to be decentered (D, E). Photos courtesy of Drs. Jason Jones (A, B, C, D), Nicole Fram (E), and Samuel Masket (F).
Landmark Findings In this first study, published in the Journal of Cataract & Refractive Surgery, we included 10 suspected dead bag syndrome cases in patients 65 and older, with a mean time between implantation and explantation (when performed) of 10.6 ± 5.6 years. It is noteworthy that no signs of zonular instability were reported during the implantation surgeries, which were all uneventful. Eight IOLs and seven capsular bags were removed because of subluxation or dislocation. Findings from the histopathologic examination of the capsular bags included: • The capsule showed signs of degradation, such as thinning or splitting, or both. • Lens epithelial cells (LECs)—the parental cells responsible for growth and development of the transparent ocular lens— were completely absent in two specimens, while the other specimens had rare LECS on the inner surface of the capsule. • Explanted IOLs were three-piece silicone IOLs or single-piece hydrophobic acrylic IOLs. One IOL optic showed a small amount of granular pigment deposition, but the optics of the other IOLs were unremarkable. • We believe splitting of the capsule occurring at the level of the zonular attachments led to subsequent in-the-bag IOL dislocation. As part of the same study, we compared the dead bag syndrome histopathological findings with those of capsules from 40 cases of in-the-bag IOL dislocation, including 26 cases with evident pseudoexfoliation material.3 We observed LECs and Soemmerring’s ring formation in all 40 cases. Capsulorhexis phimosis was also a relatively common finding, while capsular splitting/delamination was only found in one specimen. A review of the literature
indicates there is also capsular splitting/delamination in true exfoliation syndrome.4 However, in this condition, which can be associated with chronic exposure to intense heat or infrared radiation, there is usually a thin membrane of delaminated capsule on the anterior surface of the crystalline lens before cataract surgery. These differences added to evidence that dead bag syndrome is a distinct entity.
An explanted IOL and attached capsular bag from a patient with suspected dead bag syndrome is pictured. The capsular bag shows a clear capsule with a lack of proliferative material and fibrosis.
Continuing Research In a presentation at the 2023 American Academy of Ophthalmology annual meeting, we described the results from the review of another 14 cases of suspected dead bag syndrome. Of these cases, nine IOLs and 11 capsular bags were removed due to subluxation/decentration. In another study presented at the American Society of Cataract and Refractive Surgery 2023 meeting, we examined the nature of capsular bag tissues obtained from dead bag syndrome patients by using immunohistochemistry in collaboration with a Japanese group. Capsular bags from nine patients were obtained after IOL explantation, with capsular bag removal and processing for light microscopic immunohistochemical analysis for collagen type I (fibrous tissue marker), collagen type IV and laminin (both components of basement membrane or lens capsule), vimentin (lens epithelial cell cytoskeleton), and fibronectin (wound healing-related matrix component). The capsular tissue in dead bag syndrome cases showed traces of activity in a small number of LECs in postoperative wound healing and pro-fibrotic reactions, suggesting that LECs were present in the capsule in the postoperative early phase, followed by death and detachment.
Discussion There are a lot of unknowns in the etiology of dead bag syndrome, but we hypothesize that late postoperative zonular failure is related to capsule splitting/delamination occurring at the level of zonular attachments. It is important to note that this syndrome does not have any association with a particular IOL design or material. We’ve also considered other possible associations. Many surgeons wondered if our findings regarding the scarcity of LECs could be related to capsular polishing, a widely used technique during cataract surgery to prevent capsular bag fibrosis and opacification, especially in association with premium IOLs.5-9
It is, indeed, described that cortical lens fibers and LECs continue to deposit extracellular matrix and lens capsule components at their basal ends. This process contributes to the thickening and structural integrity of the capsule throughout life. However, even extensive polishing cannot completely remove all LECs, and polishing is usually not performed at the capsular bag equator, as this region is not readily visible. Therefore, to date, there is no established association between capsular polishing and this condition. We also explored Dr. Masket’s observation of cases involving white, intumescent cataracts that evolved into dead bag syndrome, suggesting oncotic pressure within the capsular bag may play a role in killing LECs. However, many dead bag cases are not related to this type of cataract, and other factors are likely involved in its origin. There have been numerous informal discussions about dead bag syndrome in the field, and surgeons have described many suspected cases that involved less severe signs, such as capsules that were floppy and delicate but still exhibited a certain amount of proliferative material within, including abnormal gel-like Soemmerring’s ring formation. It is possible that the findings described in our first study may represent the severe end of a spectrum. In discussions with researchers focused on the crystalline lens, it becomes evident there are still unknowns in the relationship between LECs and the capsule, especially in postcataract surgery cases. Although LECs are important for the formation of the capsule, this structure represents an anchor point for the basal surfaces of epithelial and fiber cells and provides necessary signals for proper lens cell proliferation, migration, and differentiation.10 In dead bag syndrome, another possibility is that the initial problem is in the capsule itself, which would initiate a cycle of LEC damage, with further damage to the capsule.
Capsular splitting or delamination, shown in the images above, is the histopathological diagnostic feature of dead bag syndrome. The capsular splitting in zonular attachment areas leads to dislocation. Lens epithelial cells are also rarely seen or are completely absent from the inner surface of the capsule.
Next Steps
REFERENCES
Our first study represented an initial formal assessment of dead bag syndrome, raising awareness of this condition and establishing a basis for further discussions and much-needed additional formal studies. We certainly hope it accomplished its goal. Our laboratory will continue addressing the many unanswered questions about the syndrome, not only about its etiology but also its manifestations. As the research continues, we advise management on a caseby-case basis, depending on presentation and status of the zonular support. LEARN MORE Scan to view the award-winning dead bag syndrome video produced by Dr. Werner in collaboration with Dr. Mamalis and other experts in the field.
1. Late In-the-Bag Intraocular Lens Dislocation: Incidence, Prevention, and Management. Gimbel HV, Condon GP, Kohnen T, Olson RJ, Halkiadakis I. Journal of Cataract & Refractive Surgery. 2005;31:2193–2204. 2. Clinical and Histopathological Findings in the Dead Bag Syndrome. Culp C, Qu P, Jones J, Fram N, Ogawa G, Masket S, Mamalis N, Werner L. Journal of Cataract & Refractive Surgery. 2022;48:177–184. 3. Pathologic Evidence of Pseudoexfoliation in Cases of In-the-Bag Intraocular Lens Subluxation or Dislocation. Liu E, Cole S, Werner L, Hengerer F, Mamalis N, Kohnen T. Journal of Cataract & Refractive Surgery. 2015;41:929–935. 4. Surgical Approach, Histopathology, and Pathogenesis in Cataract Associated with True Lens Exfoliation. Journal of Cataract & Refractive Surgery. Cooke CA, Lum DJ, Wheeldon CE, Teoh H, McGhee CN. 2007;33:735–738. 5. The Lens Capsule. Danysh BP, Duncan MK. Experimental Eye Research. 2009;88:151–164. 6. Hydropolish: A Controlled Trial on a Technique to Eradicate Residual Cortical Lens Fibers in Phacoemulsification Cataract Surgery. Wang SB, Quah XM, Amjadi S, Tong J, Francis IC. European Journal of Ophthalmology. 2015;25:571–574. 7. Fluid-Jet Technique to Polish the Posterior Capsule for Phacoemulsification Surgeries: Efficacy and Safety Evaluation. Liu Z, Cao Q, Qu B, Wang W, Ruan X, Zheng D, Jin G, Tan X, Jin L, He M, Congdon N, Lin H, Luo L, Liu Y. Journal of Cataract & Refractive Surgery. 2020;46:1508–1514. 8. Evaluation of Laser Capsule Polishing for Prevention of Posterior Capsule Opacification in a Human Ex Vivo Model. Luft N, Kreutzer TC, Dirisamer M, Priglinger CS, Burger J, Findl O, Priglinger SG. Journal of Cataract & Refractive Surgery. 2015;41:2739–2745. 9. Aspiration Curette for Anterior Capsule Polishing: Laboratory and Clinical Evaluation. Menapace R, Di Nardo S. Journal of Cataract & Refractive Surgery. 2006;32:1997–2003. 10. The Effects of Extracellular Matrix on Cell Attachment, Proliferation and Migration in a Human Lens Epithelial Cell Line. Oharazawa H, Ibaraki N, Lin LR, Reddy VN. Experimental Eye Research. 1999;69:603–610.
C A S E P R E S E N TAT I O N
A Classic Case of Dead Bag Syndrome BY AUSTIN NAK ATSUK A , MD, AND K ATHERINE HU, MD
Intraoperatively with a widely dilated pupil, the surgeons noted that the lens was offcentered and appeared to be “floating” in the clear, acellular capsule. The IOL was devoid of abnormalities or notable defects.
Eight years after an uneventful cataract surgery, a 60-yearold patient presented in clinic with complaints of a line through his vision. We noted the lens was inferiorly subluxated and seemed to be loose in the capsular bag.
There was no instability of the capsular bag and the lens stayed very well centered. The patient reported resolution of his symptoms, but we carefully monitored him for lens dislocation.
During surgery, after filling the bag and anterior chamber with viscoelastic, we tested the mobility of the lens, finding it to be freely mobile within the capsular bag. We easily dialed it out into the anterior chamber with no impediments and found that it behaved similarly to a lens that had just been placed on the original surgery day. We found no obvious damage to the haptics or haptic-optic junction of the lens. After reinspecting the bag, we found no sign of any scar, remnant lens epithelial tissue, or fibrotic changes. The capsular bag looked clearer than we would typically see even a day or two after surgery.
Some cases of this rare condition will require scleral fixation due to higher rates of zonular instability.
MORE INFORMATION This article is adapted from “Dead Bag Syndrome: Why You Can’t Just Place a Lens in the Bag,” a video presentation at the 2022 ASCRS Annual Meeting. Scan to view the video.
We rotated the lens and removed it in three pieces using micro scissors in an atraumatic fashion. We observed an excellent red reflex through the clear, acellular bag. Of note, the surgeon who had done the initial surgery was very skilled and not known to polish the capsule excessively. We believed this to be a classic case of dead bag syndrome. To treat, we placed a three-piece sulcus lens with optic capture since the capsular bag appeared to be stable intraoperatively and there were no signs of zonular laxity. We tested the lens and found it to be stable and secure.
Dr. Nakatsuka specializes in complex cataract surgery, dislocated intraocular lenses, and medical and surgical glaucoma.
Dr. Hu specializes in refractive and cataract surgery, as well as corneal transplants and IOL-related procedures.
R E S E A R C H U P D AT E
New studies show cataract surgery incorporating IOLs or devices keeping the capsular bag open/expanded rather than having the “shrink wrap” effect of the capsule around the IOL optic (human eye shown on the right) may be more effective in preventing posterior capsule opacification (PCO). The arrows (top left) show the difference in fibrosis at the edge of the capsulorhexis between a rabbit eye with an open/ expanded-bag IOL, and an eye with a standard IOL. The Miyake-Apple views (bottom left) show the difference in PCO formation.
The Open/Expanded-Bag Intraocular Lens Concept A recent study from the Intermountain Ocular Research Center adds evidence that intraocular lenses (IOLs) and devices used in cataract surgery that keep the capsular bag open and expanded, instead of tightly collapsed around the IOL, are associated with improved bag clarity. Cataract surgeons use an anterior capsulotomy technique called capsulorhexis, which essentially “shrink wraps” the capsule around the IOL optic. The performance of a capsulorhexis with a diameter smaller than the diameter of the IOL optic was one of several techniques described in the early 2000s to reduce posterior capsule opacification (PCO), the most common cataract surgery complication that requires further intervention to correct. PCO, known as a secondary cataract, occurs when leftover lens epithelial cells (LECs) accumulate and proliferate in the lens capsule after surgery and cloud vision. New studies show cataract surgery incorporating IOLs or devices that keep the capsular bag open/expanded may be even more effective in keeping the bags clear and preventing PCO, according to recent presentations by Nick Mamalis, MD, and Liliana Werner, MD, PhD, co-directors of the Intermountain Ocular Research Center based at the Moran Eye Center.
In a video presentation at the 2023 American Society of Cataract and Refractive Surgery (ASCRS) conference, the center shared results from tests of several experimental openbag concept lenses showing improved bag clarity. “PCO preventative effects may be a result of a combination of mechanisms, such as better blockage of residual LECs at the equatorial region of the bag by the 360-degree haptic ring design feature of some lenses, maintenance of a more physiological shape and geometry of the capsular bag postoperatively, and possible roles of molecular factors on LEC proliferation,” Werner wrote in the October 2022 edition of the Journal of Cataract & Refractive Surgery. Werner wrote that aqueous flow within the inner compartment of the capsular bag is also being investigated as a possible factor. “Interactions between the capsular bag and IOLs fixated within it are complex and will continue to have an impact on IOL manufacturing as our knowledge of those interactions increases,” noted Mamalis in the video presentation. LEARN MORE Scan to view the award-winning ASCRS video, “The Key to Clarity: The Open/Expanded-Bag IOL Concept.”
Stay Up to Date with IORC Research The Intermountain Ocular Research Center (IORC), directed by Nick Mamalis, MD, and Liliana Werner, MD, PhD, performs basic, in-depth scientific research on intraocular lenses, publishing multiple studies each year. Here are highlights from 2022 and 2023. ASCRS Clinical Advisory on Intracameral Moxifloxacin Injection for Infection Prophylaxis. Myers WG, Chang DF, Shorstein NH, Mah FS, Mamalis N, Miller KM; ASCRS Cataract Clinical Committee. Journal of Cataract & Refractive Surgery. 2023 Oct 1;49(10):1068-1070. Gender Disparities in Cataract and Refractive Surgery. Werner L. Journal of Cataract & Refractive Surgery. 2023 May 1;49(5):449-450. Plastic Orbital Foreign Body: The Rise of Plastic and its Unintended Consequences. Etheridge TJ, Jones J, Werner L, Mamilas N, Patel BCK. Orbit. 2023 Mar 9:1-5. Bridging the Gap Between Basic Science and Clinical Practice: The Laboratory Science Section. Werner L. Journal of Cataract & Refractive Surgery. 2023 Jan 1;49(1):1-2. Large Ciliary Body Melanocytoma with Pseudocysts: A Case Report. Simpson A, Mamalis N, Gee C, Harrie RP. BMC Ophthalmology. 2023 Jan 17;23(1):24. Corneal Endothelium Protection Provided by Ophthalmic Viscosurgical Devices During Phacoemulsification: Experimental Study in Rabbit Eyes. Park SSE, Wilkinson SW, Ungricht EL, Trapnell M, Nydegger J, Brintz BJ, Mamalis N, Olson RJ, Werner L. Journal of Cataract & Refractive Surgery. 2022 Dec 1;48(12):1440-1445. Standard for Collecting and Reporting Outcomes of IOL-based Refractive Surgery: Update for Enhanced Monofocal, EDOF, and Multifocal IOLs. Fernández J, Ribeiro FJ, Rodríguez-Vallejo M, Dupps WJ Jr, Werner L, Srinivasan S, Kohnen T. Journal of Cataract & Refractive Surgery. 2022 Nov 1;48(11):1235-1241. Effect of Simulated Lenticular Debris on Corneal Endothelial Cells: Experimental Study in Rabbit Eyes. Wilkinson SW, Park SSE, Ungricht EL, Trapnell M, Nydegger J, Cardenas IA, Brintz BJ, Mamalis N, Olson RJ, Werner L. Journal of Cataract & Refractive Surgery. 2022 Nov 1;48(11):1325-1330. The Open/Expanded-Bag Intraocular Lens Concept. Werner L. Journal of Cataract & Refractive Surgery. 2022 Oct 1;48(10):1103-1104.
Wave-Like Calcification on the Posterior Surface of an Acrylic Hydrophilic Bag-in-the-Lens (BIL) Implant. Ní Dhubhghaill S, Janssen C, Dragnea DC, Van Os L, Rozema J, Werner L, Van Dyck D, Tassignon MJ. American Journal of Ophthalmology Case Reports. 2022 Aug 27;28:101693. The Dead Bag Syndrome. Werner L. Journal of Cataract & Refractive Surgery. 2022 May 1;48(5):517-518. Clinical and Histopathological Findings in the Dead Bag Syndrome. Culp C, Qu P, Jones J, Fram N, Ogawa G, Masket S, Mamalis N, Werner L. Journal of Cataract & Refractive Surgery. 2022;48:177–184. Late-Onset Toxic Anterior Segment Syndrome After Possible Aluminum-Contaminated and Silicon-Contaminated Intraocular Lens Implantation. Wijnants D, Delbeke H, Van Calster J, Beerlandt N, Nijs I, Werner L, Mamalis N, Saelens I. Journal of Cataract & Refractive Surgery. 2022 Apr 1;48(4):443-448. Effect of Phacoemulsification Fluid Flow on the Corneal Endothelium: Experimental Study in Rabbit Eyes. Ungricht EL, Culp C, Qu P, Harris JT, Brintz BJ, Mamalis N, Olson RJ, Werner L. Journal of Cataract & Refractive Surgery. 2022 Apr 1;48(4):481-486. Force of Lifelong Crystalline Lens Growth: Chronic Traumatic Mechanical Insult to the Choroid. Strenk LM, Guo S, Lu K, Werner L, Strenk SA. Journal of Cataract & Refractive Surgery. 2022 Mar 1;48(3):342-348. Clinical, Histological and Genetic Findings in a Donor with a Clinical History of Type 1 Autoimmune Polyendocrinopathy Syndrome. Culp CJ, Pappas CM, Toso M, Qu P, Mamalis N, Hageman GS. American Journal of Ophthalmology Case Reports. 2022 Jan 20;25:101266. Dealing with Floppy Iris Syndrome. Park SSE, Wilkinson S, Mamalis N. Curr Opin Ophthalmol. 2022 Jan 1;33(1):3-8. Dysphotopsia, a Lingering Issue after Cataract Surgery: Effect of IOL Optic Size. Werner L. Journal of Cataract & Refractive Surgery. 2022 Jan 1;48(1):1-2.
MORE INFORMATION Scan to view additional publications from the Intermountain Ocular Research Center.
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