title: artificial keratoprosthesis for corneal transplant ... · 2016 5 retrospective chart review...

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TITLE: Artificial Keratoprosthesis for Corneal Transplant: Clinical Effectiveness, Cost Effectiveness, and Guidelines

DATE: 08 February 2016

RESEARCH QUESTIONS

1. What is the clinical effectiveness of artificial keratoprosthesis devices for patients requiring

corneal transplant? 2. What is the cost-effectiveness of artificial keratoprosthesis devices for patients requiring

corneal transplant? 3. What are the evidence-based guidelines regarding appropriate clinical indications for

artificial keratoprosthesis devices? KEY FINDINGS

Three systematic reviews, 27 non-randomized studies, one economic evaluation, and one evidence-based guideline were identified regarding artificial keratoprosthesis devices for patients requiring corneal transplant. METHODS

A limited literature search was conducted on key resources including PubMed, The Cochrane Library, University of York Centre for Reviews and Dissemination (CRD) databases, ECRI, Canadian and major international health technology agencies, as well as a focused Internet search. No filters were applied to limit the retrieval by study type. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between January 1, 2011 and January 25, 2016. Internet links were provided, where available. The summary of findings was prepared from the abstracts of the relevant information. Please note that data contained in abstracts may not always be an accurate reflection of the data contained within the full article.

Artificial Keratoprosthesis for Corneal Transplant 2

SELECTION CRITERIA

One reviewer screened citations and selected studies based on the inclusion criteria presented in Table 1.

Table 1: Selection Criteria

Population Patients (of any age) requiring corneal transplant

Intervention Artificial keratoprosthesis devices (e.g., Boston Keratoprosthesis, Alpha Cor Artificial Cornea, Osteo-Odonto-Keratoprosthesis, KeraKlear Artificial

Cornea)

Comparators Human donor corneas;

No comparator

Outcomes Q1: Clinical effectiveness (e.g., visual acuity; restoration of shape, clarity or integrity of cornea; failure rate); Harms

Q2: Cost-effectiveness outcomes Q3: Evidence-based guidelines regarding appropriate clinical indications for artificial keratoprosthesis

Study Designs Health technology assessments, systematic reviews, meta-analyses,

randomized controlled trials, non-randomized studies, evidence-based guidelines

RESULTS

Rapid Response reports are organized so that the higher quality evidence is presented first. Therefore, health technology assessment reports, systematic reviews, and meta-analyses are presented first. These are followed by randomized controlled trials, non-randomized studies, economic evaluations, and evidence-based guidelines. Three systematic reviews, 27 non-randomized studies, one economic evaluation, and one evidence-based guideline were identified regarding artificial keratoprosthesis devices for patients requiring corneal transplant. No health technology assessments or randomized controlled studies were identified. Additional references of potential interest are provided in the appendix.

OVERALL SUMMARY OF FINDINGS

Three systematic reviews,1-3 27 non-randomized studies,4-30 one economic evaluation,31 and one evidence-based guideline32 were identified regarding artificial keratoprosthesis devices for patients requiring corneal transplant. Results from one systematic review1 demonstrated an increased likelihood of visual improvement maintenance in patients with donor corneal graft failure upon the use of the type I Boston keratoprosthesis (KPro) when compared with repeat donor penetrating keratoplasty. In addition, no higher risk of postoperative glaucoma was observed with the KPro.1 The second systematic review also noted successful clinical use of KPro; however, the authors highlighted accessibility issues as problematic (particularly financial issues, lack of adequately trained surgeons, and shortages of donor corneas).2 The third systematic review limited its inclusion criteria to randomized controlled trials. It did not identify any trials and was subsequently unable


to determine optimal treatment with regard to Artificiall (keratoprosthesis) corneas in patients who had failed conventional corneal transplant.3 Twenty-seven4-30 non-randomized studies were identified regarding artificial keratoprosthesis devices for patients requiring corneal transplant. While most studies identified some improvement in visual acuity, complications remain a concern. Study details and conclusions are provided in Table 2.

Table 2: Summary of Findings from Non-Randomized Studies First Author,

Year

Study Type,

Size Indications Outcomes Conclusions

Auro Keratoprosthesis

Sharma, 20154 Prospective

interventional study

N=10 eyes (in 10 patients)

End-stage corneal disease

BCVA

Retention

Complications

Need for second

surgery

Viable option in end-stage corneal disease.

9/10 patients retained

keratoprosthesis.

Complications were observed.

Boston Type I Keratoprosthesis

Wagoner, 2016

5

Retrospective chart review

N=75 KPro-I procedures

NR Post-operative infections

Post-operative infections are a serious

issue compromising retention of KPro-1 and visual outcomes.

Hager, 20157 Retrospective

review

N=24

Failed

keratoplasty: o Corneal

edema

(n=13) o Trauma

(n=8)

o Keratononus (n=3)

BCVA

Retention

In patients with failed

keratoplasty, the KPro-I was associated with: o excellent prognosis

of retention; o satisfactory visual

improvement.

Kosker, 20158 Retrospective

analysis

N=37 eyes (in

37 patients)

Preoperative BCVA=20/40 in

fellow eye

Failed penetrating keratoplasy

(n=28)

Primary KPro (n=9)

BCVA

Retention

Complications

Half of the patients achieved minimum VA required for binocular

functioning.

One-third of patients achieved a BCVA

somewhat similar to fellow eye.

Good retention.

Complications similar to previously reported.

Phillips, 20159 Retrospective

review

N=4

Failed keratoplasties: o Iris atrophy

(n=2) o Chandler

syndrome

(n=2)

BCVA KPro-I may offer a better prognosis than traditional keratoplasty

in reestablishing corneal clarity in patients with iridocorneal endothelial

syndromes.


Table 2: Summary of Findings from Non-Randomized Studies

First Author, Year

Study Type, Size

Indications Outcomes Conclusions

Rudnisky, 2015

10

Prospective parameters were collected

N=300 eyes (of 300 patients)

NR logMAR visual outcomes

KPro-I is an effective device for rehabilitation in advanced ocular

surface disease that results in significantly improved VA.

Brown, 201411

Retrospective

review

N=9 eyes

Keratopathy

caused by: o HSV o HZV

Visual outcomes

Retention

Complications

In eyes with HSV

keratopathy, KPro-I is associated with: o excellent prognosis

for retention; o highly satisfactory

visual improvement;

o acceptably low prevalence of sight-threatening

complications.

Aforementioned results were not observed in

eyes with HZV keratoplasty.

de Oliveira, 2014

12

Prospective interventional study


Failed graft (n=16)

Chemical injury

(n=10)

Stevens-Johnson

syndrome (n=4)

VA

KPro-I stability

Postoperative

complications

In the developing world, KPro-I keratoprosthesis is a viable option after

multiple keratoplasty failures and in conditions with a poor

prognosis for keratoplasty.

de Rezende Couto

Nascimento, 2014

13

Retrospective chart analysis


Various diagnoses

(most non-standard for KPro-I

implantation)

How primary diagnoses affect

post-operative VA

Complications

Most cases showed improvement in VA.

Posterior segment complications and infections resulted in

persistent loss of vision.

Phillips, 201414

Retrospective review

N=9 eyes

Alkali burns (n=7

Acid burns (n=1)

Thermal burns (n=1)

Visual outcomes

Retention

Complications

In most cases, KPro-I is associated with: o highly satisfactory

visual outcomes;

o prosthesis retention; o serious

complications are

common.

Ciolino, 201315

Prospective study


NR Retention KPro-I seems to be viable option for non-

candidates of PK

Ocular surface disease due to autoimmune

disease had lowest retention rate.



First Author, Year

Study Type, Size


Goldman, 2013

16


N=98 eyes (of

94 patients)

NR Posterior segment completions

These complications occur in a significant percentage of patients,

resulting in persistent reduction in VA.

Magalhaes, 2013

17

Prospective study


Ocular burns VA

Retention

Complications

There is support for the use of the KPro-I in

managing bilateral LSCD secondary to ocular burns.

Munoz-

Gutierrez, 2013

18

Retrospective

analysis


Most frequent

diagnoses were bullous keratopathy,

autoimmune diseases

Visual function

Complications

Visual function

improved in most patients.

Increased risk for serious sight-

threatening complications in patient with prior multiple ocular

surgeries and alterations of systemic immunity.

Palioura,

201319

Retrospective

review


Mucous

membrane pemphigoid

VA

Retention

Complications

Clinical outcomes

associated with KPro-I implantation in these patients are guarded.

Chan, 201220


N=10 cases

Chemical injuries (n=4)

Stevens-Johnson syndrome (n=3)

Ocular cicatricial pemphigoid

(n=2)

Congenital aniridia (n=1)

Infectious keratitis

Infectious keratitis can occur even when

patients are on prophylactic vancomycin and 4

th-

generation fluoroquinolone.

Reported case of ocular

D. constricta.

Patel, 201221



Various conditions

VA

Retention

Complications

KPro-I provides visual recovery for eyes with

multiple PK failures or in those with a poor prognosis for primary

PK.

Excellent retention rates.

Trend towards decline in VA with time and late complications.



First Author, Year

Study Type, Size


Ramchandran, 2012

22


N=10 eyes

Infectious endophthalmitis

Clinical characteristics of infectious

endophthalmitis after implantation

Higher incidence, delayed onset, and high risk for recurrence of

infectious endophthalmitis compared with

postoperative endophthalmitis.

Concurrent use of

topical vancomycin is recommended.

Shihadeh, 2012

23



NR BCVA

Complications

Reasonable safe and effective for patients

with corneal blindness (and those for whom prognosis is poor for

natural corneal grafting).

Greiner, 2011

24

Cohort study

N=36 eyes

Failed corneal transplants (n=19)

Chemical injury (n=10)

Aniridia (n=5)

VA

Complications

Viable option for salvaging vision; however, some patients

lost vision over postoperative course.

Glaucoma and

complications related to glaucoma remain significant challenges.

Sejpal, 201125

Retrospective

review

N=28 procedures (in 23 eyes of 22

patients)

LSCD VA

Retention

Complications

KPro-I results in

significant CDVA improvement in majority of LSCD patients and

CDVA of 20/50 or better in more than two-thirds of patients 3 years post-

surgery.

PED was the most common complication.

PED is associated with

increased rate of sterile stromal necrosis and lower retention rates.

Boston Type I and II Keratoprosthesis

Duignan,

20156

Retrospective

chart review

N=31 (KPro-I implantations)

N=3 (KPro-II

implantations)

NR BCVA

Retention

Complications

Excellent VA and

retention in a long follow-up (42 months, SD 31 months).

Complications remain considerable source of morbidity.



First Author, Year

Study Type, Size


KeraKlear Kpro

Alio, 201527

Prospective study

N=15a

High risk of failure with PK

Retention

Complications

Viable alternative to corneal transplantation.

KeraKlear KPro is better

tolerated and less prone to complications with epidescemetical

implantation.

Cases with poor corneal quality are better

associated to lamellar fenestrated donor corneal graft.

Osteo-Odonto-Keratoprosthesis

Lee, 201428

Prospective study

N=18

OOKP (n=9)

age-matched

controls (n=9)

Optical and visual performance

OOKP provides patients with good level of VA,

with significant reductions in glare.

Narayanan, 2012

29

Retrospective analysis

N=26

Blindness occurring due

to: o Stevens-

Johnson

syndrome (n=23)

o Chemical

burns (n=3)

VA

Complications

Successful visual rehabilitation occurred

in 19 patients

No improvement in 4 patients.

de la Paz, 2011

30

Retrospective cohort study

N=227

Various indications

Effect of clinical factors on long-term anatomical

function and functional success

Surgical technique, primary diagnosis, age, and postoperative

complications can affect long-term function and functional success of

OOKP. BCVA = best corrected visual acuity; CDVA = corrected distance visual acuity; HSV = herpes simplex virus; HZV = herpes zoster virus; KPro-I = Boston type I keratoprosthesis; logMAR = lorgarithm of the minimal angle of resolution; LSCD = corneal limbal stem cell deficiency; NR = not reported; OOKP = Osteo-Odonto-Keratoprosthesis; PED = persistent corneal epithelial defect; PK = penetrating keratoplasty; SD = standard deviation; VA = visual acuity. a epidescemetic KPro w as implanted intralamellar in 11eyes and epidescemetical in four eyes.

The authors of the one identified economic analysis31 reported that, from the perspective of the third party payer, the use of the type II KPro was associated with a cost utility of $63,196 per quality adjusted life year. Thus, the authors concluded that decreases in both patient and societal costs may be realized when efforts were put forth to identify patients less likely to benefit from either type I KPro or traditional corneal transplantation.31 With regard to appropriate clinical indications for artificial keratoprosthesis devices, the American Academy of Ophthalmology32 noted that keratoprosthesis devices are being used for unilateral or bilateral ocular trauma, unilateral or bilateral herpetic keratitis, unilateral or bilateral aniridia, unilateral or bilateral Steven-Johnson syndrome, and unilateral or bilateral congenital corneal opacification; however, the evidence for all of these indications was determined to be


grade III, insufficient and discretionary. In addition, osteo-odonto-keratoprosthesis has provided some success for patients with severe dry eye and autoimmume ocular surface diseases; however, the evidence was graded as III, insufficient and discretionary.32


REFERENCES SUMMARIZED

Health Technology Assessments

No literature identified. Systematic Reviews and Meta-analyses

1. Ahmad S, Mathews PM, Lindsley K, Alkharashi M, Hwang FS, Ng SM, et al. Boston type 1

keratoprosthesis versus repeat donor keratoplasty for corneal graft failure: a systematic review and meta-analysis. Ophthalmology. 2016 Jan;123(1):165-77. PubMed: PM26545318

2. Al Arfaj K. Boston keratoprosthesis - clinical outcomes with wider geographic use and

expanding indications - a systematic review. Saudi J Ophthalmol [Internet]. 2015 Jul [cited 2016 Feb 5];29(3):212-21. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4487949 PubMed: PM26155082

3. Akpek EK, Alkharashi M, Hwang FS, Ng SM, Lindsley K. Artificial corneas versus donor corneas for repeat corneal transplants. Cochrane Database Syst Rev [Internet]. 2014 Nov 5 [cited 2016 Feb 5];11:CD009561. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4270365 PubMed: PM25372407

Randomized Controlled Trials

No literature identified. Non-Randomized Studies

Auro Keratoprosthesis 4. Sharma N, Falera R, Arora T, Agarwal T, Bandivadekar P, Vajpayee RB. Evaluation of a

low-cost design keratoprosthesis in end-stage corneal disease: a preliminary study. Br J Ophthalmol. 2015 Aug 13. [Epub ahead of print] PubMed: PM26271267

Boston Type I or II Keratoprosthesis 5. Wagoner MD, Welder JD, Goins KM, Greiner MA. Microbial keratitis and endophthalmitis

after the Boston type 1 keratoprosthesis. Cornea. 2016 Jan 13. [Epub ahead of print] PubMed: PM26764885

6. Duignan ES, Ni Dhubhghaill S, Malone C, Power W. Long-term visual acuity, retention

and complications observed with the type-I and type-II Boston keratoprostheses in an Irish population. Br J Ophthalmol. 2015 Dec 1. [Epub ahead of print] PubMed: PM26628625

http://www.ncbi.nlm.nih.gov/pubmed/26545318http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4487949http://www.ncbi.nlm.nih.gov/pubmed/26155082http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4270365http://www.ncbi.nlm.nih.gov/pubmed/25372407http://www.ncbi.nlm.nih.gov/pubmed/26271267http://www.ncbi.nlm.nih.gov/pubmed/26764885http://www.ncbi.nlm.nih.gov/pubmed/26628625


7. Hager JL, Phillips DL, Goins KM, Kitzmann AS, Greiner MA, Cohen AW, et al. Boston type 1 keratoprosthesis for failed keratoplasty. Int Ophthalmol. 2015 May 16. [Epub ahead of print]. PubMed: PM25975459

8. Kosker M, Suri K, Rapuano CJ, Ayres BD, Nagra PK, Raber IM, et al. Long-term results of

the Boston keratoprosthesis for unilateral corneal disease. Cornea. 2015 Sep;34(9):1057-62. PubMed: PM26114818

9. Phillips DL, Goins KM, Greiner MA, Alward WL, Kwon YH, Wagoner MD. Boston type 1

keratoprosthesis for iridocorneal endothelial syndromes. Cornea. 2015 Nov;34(11):1383-6. PubMed: PM26398156

10. Rudnisky CJ, Belin MW, Guo R, Ciolino JB, Boston Type 1 Keratoprosthesis Study Group.

Visual acuity outcomes of the Boston keratoprosthesis type 1: multicenter study results. Am J Ophthalmol. 2015 Nov 10. [Epub ahead of print]. PubMed: PM26550696

11. Brown CR, Wagoner MD, Welder JD, Cohen AW, Goins KM, Greiner MA, et al. Boston

keratoprosthesis type 1 for herpes simplex and herpes zoster keratopathy. Cornea. 2014 Aug;33(8):801-5. PubMed: PM24932767

12. de Oliveira LA, Pedreira Magalhães F, Hirai FE, de Sousa LB. Experience with Boston

keratoprosthesis type 1 in the developing world. Can J Ophthalmol. 2014 Aug;49(4):351-7. PubMed: PM25103652

13. de Rezende Couto Nascimento V, de la Paz MF, Rosandic J, Stoiber J, Seyeddain O,

Grabner G, et al. Influence of primary diagnosis and complications on visual outcome in patients receiving a Boston type 1 keratoprosthesis. Ophthalmic Res. 2014;52(1):9-16. PubMed: PM24853485

14. Phillips DL, Hager JL, Goins KM, Kitzmann AS, Greiner MA, Cohen AW, et al. Boston type

1 keratoprosthesis for chemical and thermal injury. Cornea. 2014 Sep;33(9):905-9. PubMed: PM25055151

15. Ciolino JB, Belin MW, Todani A, Al-Arfaj K, Rudnisky CJ, Boston Keratoprosthesis Type 1 Study Group. Retention of the Boston keratoprosthesis type 1: multicenter study results. Ophthalmology [Internet]. 2013 Jun [cited 2016 Feb 5];120(6):1195-200. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3674188 PubMed: PM23499061

16. Goldman DR, Hubschman JP, Aldave AJ, Chiang A, Huang JS, Bourges JL, et al.

Postoperative posterior segment complications in eyes treated with the Boston type I keratoprosthesis. Retina. 2013 Mar;33(3):532-41. PubMed: PM23073339

http://www.ncbi.nlm.nih.gov/pubmed/25975459http://www.ncbi.nlm.nih.gov/pubmed/26114818http://www.ncbi.nlm.nih.gov/pubmed/26398156http://www.ncbi.nlm.nih.gov/pubmed/26550696http://www.ncbi.nlm.nih.gov/pubmed/24932767http://www.ncbi.nlm.nih.gov/pubmed/25103652http://www.ncbi.nlm.nih.gov/pubmed/24853485http://www.ncbi.nlm.nih.gov/pubmed/25055151http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3674188http://www.ncbi.nlm.nih.gov/pubmed/23499061http://www.ncbi.nlm.nih.gov/pubmed/23073339


17. Magalhães FP, Hirai FE, de Sousa LB, de Oliveira LA. Boston type 1 keratoprosthesis outcomes in ocular burns. Acta Ophthalmol. 2013 Sep;91(6):e432-e436. PubMed: PM23406295

18. Muñoz-Gutierrez G, Alvarez de Toldeo J, Barraquer RI, Vera L, Couto Valeria R, Nadal J,

et al. Post-surgical visual outcome and complications in Boston type 1 keratoprosthesis. Arch Soc Esp Oftalmol. 2013 Feb;88(2):56-63. PubMed: PM23433193

19. Palioura S, Kim B, Dohlman CH, Chodosh J. The Boston keratoprosthesis type I in

mucous membrane pemphigoid. Cornea. 2013 Jul;32(7):956-61. PubMed: PM23538625

20. Chan CC, Holland EJ. Infectious keratitis after Boston type 1 keratoprosthesis

implantation. Cornea. 2012 Oct;31(10):1128-34. PubMed: PM22960647

21. Patel AP, Wu EI, Ritterband DC, Seedor JA. Boston type 1 keratoprosthesis: the New

York Eye and Ear experience. Eye (Lond) [Internet]. 2012 Mar [cited 2016 Feb 5];26(3):418-25. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3298984 PubMed: PM22173079

22. Ramchandran RS, Diloreto DA Jr, Chung MM, Kleinman DM, Plotnik RP, Graman P, et al. Infectious endophthalmitis in adult eyes receiving Boston type I keratoprosthesis. Ophthalmology. 2012 Apr;119(4):674-81. PubMed: PM22266108

23. Shihadeh WA, Mohidat HM. Outcomes of the Boston keratoprosthesis in Jordan. Middle East Afr J Ophthalmol [Internet]. 2012 Jan [cited 2016 Feb 5];19(1):97-100. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3277032 PubMed: PM22346122

24. Greiner MA, Li JY, Mannis MJ. Longer-term vision outcomes and complications with the Boston type 1 keratoprosthesis at the University of California, Davis. Ophthalmology. 2011 Aug;118(8):1543-50. PubMed: PM21397948

25. Sejpal K, Yu F, Aldave AJ. The Boston keratoprosthesis in the management of corneal limbal stem cell deficiency. Cornea. 2011 Nov;30(11):1187-94. PubMed: PM21885964

26. Verdejo-Gómez L, Peláez N, Gris O, Güell JL. The Boston Type I keratoprosthesis: an assessment of its efficacy and safety. Ophthalmic Surg Lasers Imaging. 2011 Nov;42(6):446-52. PubMed: PM21919432

http://www.ncbi.nlm.nih.gov/pubmed/23406295http://www.ncbi.nlm.nih.gov/pubmed/23433193http://www.ncbi.nlm.nih.gov/pubmed/23538625http://www.ncbi.nlm.nih.gov/pubmed/22960647http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3298984http://www.ncbi.nlm.nih.gov/pubmed/22173079http://www.ncbi.nlm.nih.gov/pubmed/22266108http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3277032http://www.ncbi.nlm.nih.gov/pubmed/22346122http://www.ncbi.nlm.nih.gov/pubmed/21397948http://www.ncbi.nlm.nih.gov/pubmed/21885964http://www.ncbi.nlm.nih.gov/pubmed/21919432


KeraKlear Kpro 27. Alio JL, Abdelghany AA, Abu-Mustafa SK, Zein G. A new epidescemetic keratoprosthesis:

pilot investigation and proof of concept of a new alternative solution for corneal blindness. Br J Ophthalmol. 2015 Nov;99(11):1483-7. PubMed: PM25868791

Osteo-Odonto-Keratoprosthesis 28. Lee RM, Ong GL, Lam FC, White J, Crook D, Liu CS, et al. Optical functional performance

of the osteo-odonto-keratoprosthesis. Cornea. 2014 Oct;33(10):1038-45. PubMed: PM25127188

29. Narayanan V, Nirvikalpa N, Rao SK. Osteo-odonto-keratoprosthesis - a maxillofacial

perspective. J Craniomaxillofac Surg. 2012 Dec;40(8):e426-e431. PubMed: PM22425501

30. de la Paz MF, de Toledo JA, Charoenrook V, Sel S, Temprano J, Barraquer RI, et al.

Impact of clinical factors on the long-term functional and anatomic outcomes of osteo-odonto-keratoprosthesis and tibial bone keratoprosthesis. Am J Ophthalmol. 2011 May;151(5):829-39. PubMed: PM21310387

Economic Evaluations

31. Ament JD, Stryjewski TP, Pujari S, Siddique S, Papaliodis GN, Chodosh J, et al. Cost

effectiveness of the type II Boston keratoprosthesis. Eye (Lond) [Internet]. 2011 Mar [cited 2016 Feb 5];25(3):342-9. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3178310 PubMed: PM21183944

Guidelines and Recommendations

32. American Academy of Ophthalmology Cornea/External Disease Panel. Corneal edema

and opacification [Internet]. San Francisco: American Academy of Ophthalmology; 2013 [cited 2016 Feb 5]. (Preferred Practice Pattern® guideline). Available from: http://www.aao.org/preferred-practice-pattern/corneal-edema-opacification-ppp--2013 See: Keratoprosthesis

PREPARED BY:

Canadian Agency for Drugs and Technologies in Health Tel: 1-866-898-8439 www.cadth.ca

http://www.ncbi.nlm.nih.gov/pubmed/25868791http://www.ncbi.nlm.nih.gov/pubmed/25127188http://www.ncbi.nlm.nih.gov/pubmed/22425501http://www.ncbi.nlm.nih.gov/pubmed/21310387http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3178310http://www.ncbi.nlm.nih.gov/pubmed/21183944http://www.aao.org/preferred-practice-pattern/corneal-edema-opacification-ppp--2013http://www.cadth.ca/


APPENDIX – FURTHER INFORMATION:

Non-Randomized Studies - Alternate Comparator

33. Fadous R, Levallois-Gignac S, Vaillancourt L, Robert MC, Harissi-Dagher M. The Boston

Keratoprosthesis type 1 as primary penetrating corneal procedure. Br J Ophthalmol. 2015 Dec;99(12):1664-8. PubMed: PM26034079

Review Articles

34. Avadhanam VS, Liu CS. A brief review of Boston type-1 and osteo-odonto

keratoprostheses. Br J Ophthalmol. 2015 Jul;99(7):878-87. PubMed: PM25349081

35. Avadhanam VS, Smith HE, Liu C. Keratoprostheses for corneal blindness: a review of

contemporary devices. Clin Ophthalmol [Internet]. 2015 [cited 2016 Feb 5];9:697-720. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4406263 PubMed: PM25945031

36. Klufas MA, Yannuzzi NA, D'Amico DJ, Kiss S. Vitreoretinal aspects of permanent keratoprosthesis. Surv Ophthalmol. 2015 May;60(3):216-28. PubMed: PM25890625

37. Lee WB, Shtein RM, Kaufman SC, Deng SX, Rosenblatt MI. Boston keratoprosthesis:

outcomes and complications: a report by the American Academy of Ophthalmology. Ophthalmology. 2015 Jul;122(7):1504-11. PubMed: PM25934510

38. Odorcic S, Haas W, Gilmore MS, Dohlman CH. Fungal infections after Boston type 1

keratoprosthesis implantation: literature review and in vitro antifungal activity of hypochlorous acid. Cornea. 2015 Dec;34(12):1599-605. PubMed: PM26488624

39. Behlau I, Martin KV, Martin JN, Naumova EN, Cadorette JJ, Sforza JT, et al. Infectious endophthalmitis in Boston keratoprosthesis: incidence and prevention. Acta Ophthalmol. 2014 Nov;92(7):e546-e555. PubMed: PM24460594

40. Modjtahedi BS, Eliott D. Vitreoretinal complications of the Boston Keratoprosthesis. Semin

Ophthalmol. 2014 Sep;29(5-6):338-48. PubMed: PM25325859

41. Robert MC, Dohlman CH. A review of corneal melting after Boston Keratoprosthesis.

Semin Ophthalmol. 2014 Sep;29(5-6):349-57. PubMed: PM25325860

http://www.ncbi.nlm.nih.gov/pubmed/26034079http://www.ncbi.nlm.nih.gov/pubmed/25349081http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4406263http://www.ncbi.nlm.nih.gov/pubmed/25945031http://www.ncbi.nlm.nih.gov/pubmed/25890625http://www.ncbi.nlm.nih.gov/pubmed/25934510http://www.ncbi.nlm.nih.gov/pubmed/26488624http://www.ncbi.nlm.nih.gov/pubmed/24460594http://www.ncbi.nlm.nih.gov/pubmed/25325859http://www.ncbi.nlm.nih.gov/pubmed/25325860


Additional References

42. Keratoprosthesis algorithm [Internet]. San Francisco: American Academy of

Ophthalmology; c2016 [cited 2016 Feb 5]. Available from: http://www.aao.org/image/keratoprosthesis-algorithm

http://www.aao.org/image/keratoprosthesis-algorithm

Research questionSkey FINDINGSMethodsResultsOverall summary of findingsReferences summarizedAppendix – Further information:Review Articles

title: artificial keratoprosthesis for corneal transplant ... · 2016 5 retrospective chart review...

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