Study

Study design

Study dates

Country

Follow‐up

Number of participants

Number with repeat PK

Funding source and declarations of interest

Boston Type 1 KPro Study

Multicenter retrospective and prospective case
series

2003‐2008

18 sites in the USA

Mean 17 (range 1 week to 6.1 years)

300 (300 eyes)

244/300 (81.3%)

"No surgeons in the study group have any proprietary interest in the Boston Type 1 keratoprosthesis."

Aldave 2012a

Retrospective case series

2004‐2011

USA (Jules Stein Eye Institute)

Mean 24 months (range 0 to 84 months)

94 (98 eyes, 110 devices)

82/98 (83.7%) eyes

"The author(s) have no proprietary or commercial interest in any materials discussed in this article."

Aldave 2012b

Retrospective case series

2004‐2011

Armenia, India, Indonesia, Nepal, Philippines, Russia, and Saudi Arabia

Mean 14.2 months (range 0 to 48 months)

100 (107 eyes, 113 devices)

74/107 (69.2%) eyes

"The author(s) have no proprietary or commercial interest in any materials discussed in this article."

Chew 2009

Retrospective case series

2005‐2007

USA (Wills Eye Institute)

Mean 16 months (range 6 to 28 months)

37 (37 eyes)

29/37 (78.4%)

"Dr. H. F. Chew was supported by the E. A. Baker Fellowship Fund Grant from the Canadian National Institute for the Blind."

Dunlap 2010

Retrospective case series

2004‐2008

USA (Wilmer Eye Institute and University of Rochester Eye Institute)

6 months

122 (126 eyes)

112/126 (88.9%) eyes

"The authors have no proprietary or commercial interest in any of the materials discussed in this article."

Greiner 2011

Retrospective case series

2004‐2008

USA (University of California, Davis)

Mean 19 months (range 1 to 48 months)

28 (30 eyes)

26/30 (86.7%) eyes

"The author(s) have no proprietary or commercial interest in any materials discussed in this article."

Guell 2011

Retrospective case series

2006‐2011

Spain (Instituto Microcirugia Ocular of Barcelona)

Mean 20 months (range 1 to 56 months)

53 (54 eyes)

49/54 (90.7%) eyes

"This work has been done with the help of the Ophthalmological Society of the Valencian Community, Valencia, Spain. The first author of the work has been awarded a fellowship for further study of residents at the Ocular Microsurgery Institute of Barcelona, sponsored by Pfizer."; "The authors have no financial or proprietary interest in the materials presented herein."

Kamyar 2012

Retrospective case series

2003‐2009

USA (Kellogg Eye Center, University of Michigan)

Mean 17 months (range 3 to 67 months)

29 (30 eyes)

23/30 (76.7%) eyes

"Supported in part by a departmental grant from the Research to Prevent Blindness (RPB), the RPB Lew R.Wasserman Merit Award, and the National Eye Institute K23 Mentored Clinician Scientist Award."

Koller 2012

Retrospective case series

2009‐2011

Germany (Neuhann & Colleagues)

Mean 9.1 months (range 1 to 21 months)

14 (14 eyes)

13/14 (92.9%)

"The corresponding author indicates no conflict of interests."

Patel 2012

Retrospective case series

2006‐2010

USA (New York Eye and Ear Infirmary)

Mean 21.5 months (range 3 to 47 months)

51 (58 eyes)

47/58 (81.0%) eyes

"The authors declare no conflict of interest."

Shihadeh 2012

Retrospective case series

2007‐2010

Jordan (King Abdullah University Hospital)

Mean 18 months (range 3 to 36 months)

19 (20 eyes)

19/20 (95%) eyes

"Source of Support: Nil, Conflict of Interest: None declared."

Talajic 2012

Retrospective case series

2008‐2009

Canada (Centre Hospitalier de l’Université de

Montréal, Hôpital Notre‐Dame),

Mean 16.5 months

38 (38 eyes)

25/38 (65.8%) eyes

"Supported by a research grant from the Fonds de Recherche en Ophthalmologie de l’Université de Montréal, Montreal, Canada; and a Resident Research Grant from Pfizer Canada (Kirkland, Canada)"; "The authors indicate no financial conflict of interest."

Early model of Boston keratoprosthesis (known as Dohlman‐Doane keratoprosthesis)

Aquavella 2005

Retrospective case series

2003‐2005

USA (University of Rochester Eye Institute)

12 months

25 (25 eyes)

22/25 (88%)

"The authors have no proprietary interest in any products mentioned in this article."

Harissi‐Dagher 2007

Retrospective case series

1990‐2004

USA (Massachusetts Eye and Ear Infirmary)

Mean 35 months (range 1 to 108 months)

128 (157 eyes)

157/157 (100%)

eyes

"Supported by a Massachusetts Eye and Ear Infirmary fund and the Alcon Research Institute award."

Study

Number with BCVA ≥ 20/100

Other visual acuity outcomes

Proportion of graft failures*

Number of device extrusions

1 year

2 years

5 years

1 year

2 years

5 years

Boston Type 1 KPro Study

29 of 62 (46.8%)

NR

NR

"The number of patients with best‐corrected VA (BCVA) 20/200 or better went from 3.6% preoperatively to 57% postoperatively. Nineteen percent had postoperative vision of 20/40 or better."

21/300 (7.0%) (12/244, 4.9% in participants with previous failed graft); failure rate 6% (n = 161 eyes)

NR; failure rate 11% (n = 91 eyes)

NR

4/300 (1.3%)

Aldave 2012a

42 of 77 (54.5%)

22 of 47 (46.8%)

5 of 7 (71.4%)

NR

22/110 (20.0%) devices failed at final follow‐up; failure rate 8.3% (n = 74)

NR; failure rate 21.6% (n = 45)

NR; failure rate

38.4% (n = 5)

NR

Aldave 2012b

33 of 65 (50.8%)

18 of 34 (52.9%)

0 of 1 (0%)

"In 82.2% (74/90) of the eyes in the international series in which the keratoprosthesis was retained at the final follow‐up visit, the final postoperative CDVA was better than the preoperative CDVA, and in 13.3% (12/90) of eyes, the preoperative and postoperative CDVAs were the same."

22/113 (19.5%) devices failed at final follow‐up; failure rate 20.8% (n = 58)

NR; failure rate 25.4% (n = 18)

NA

NR

Chew 2009

NR

NR

NA

The mean BCVA at any point postoperatively and at last follow‐up were 20/50 (range: 20/400 to 20/20; P < 0.001) and 20/90 (range: light perception to 20/25; P < 0.001), respectively. The mean BCVA over time at 6 ,12, and 18 months showed significant visual improvement (P < 0.001) compared with BCVA preoperatively.16 patients (43%) achieved a BCVA better than or equal to 20/50 at last follow‐up (time not specified); 23 of 30 patients (76.7%) with minimum follow‐up of 12 months had a BCVA better than or equal to 20/200)

1/30 (3%) (the type 2 model)

NA

NA

1/30 (3%) (the type 2 model)

Dunlap 2010

NA

NA

NA

"Of 126 eyes, 104 (82.5%) achieved improved vision within the first 6 months postoperatively."; "At the 3‐month follow‐up, 54% of eyes had 20/200 vision or better, and 18% were 20/40 or better. Twenty‐two of the eyes (22/126; 17.4%) did not have improved vision. Eight eyes lost vision"

NA

NA

NA

3/126 (2.4%) extrusion/corneal melt at 6 months

Greiner 2011

NR

NR

NA

In the subgroup of 16 eyes followed for at least 1 year after keratoprosthesis implantation (mean follow‐up, 28 months; range 12 to 48 months; SD 12.8 months; median 24 months), vision was ≥ 20/200 in 75% of eyes and ≥ 20/40 in 25% of eyes

5/30 (16.7%) at mean of 19 months follow‐up

NR

NR

NR

Guell 2011

12/54 eyes at final follow‐up

NR

NR

"The postoperative BCVA was 0.097 (SD 0.18). Thirty‐three (33%) achieved a BCVA ≥ 0.1 (18 eyes) and 7.4% achieved ≥ 0.4 (4 eyes). Rapid improvement in the BCVA was observed. The measurements obtained 3 months after the operation do not differ significantly from the final BCVA."

2/54 (3.7%); failure rate 4%

NR

NR

NR

Kamyar 2012

NR

NR

NR

Mean postoperative BCVA 20/390 (range 20/40 to LP; n = 16) at one year; "When comparing preoperative BCVA with final BCVA, vision improved in 19 of 30 eyes (63%) and was unchanged in 7 eyes (23%). Vision worsened in 4 eyes (13%) because of glaucoma in 3 eyes, 2 of which became no light perception, and retinal detachment occurred in 1 eye”

6/20 (30%)

NR

NR

NR

Koller 2012

2 of 4 (50%)

NA

NA

10 of 14 had BCVA ≥ 0.03, 1 had CF, and 3 had HM at the last follow‐up (mean 9; range 1 to 21 months)

failure rate 0% (n = 4)

NA

NA

None

Patel 2012

NR

NR

NA

"At the last follow‐up, 43.1% of eyes attained BCVA ≥ 20/200. By follow‐up, the percentage of eyes with BCVA ≥ 20/200 showed a decreasing trend with 74.5% (35/47) at 1 year, 50.0% (16/32) at 2 years, and 36.3% (4/11) at 3 years"; "At the last follow‐up, BCVA improved in 55.2% of eyes (32/58), remained the same in 27.6% of eyes (16/58), and worsened in 17.2% of eyes (10/58) because of postoperative complications."

7/58 (12.1%)

None

NA

4/58 (6.9%)

Shihadeh 2012

NR

NR

NA

"In the subgroup of 15 eyes followed for at least 1 year (median follow‐up: 20 months; range: 12–36 months) after KPro implantation, vision improved in 86.7% of eyes; it was 20/200 in 66.7% of eyes and 20/50 in 26.7% of eyes."

0/15; failure rate 0% (n = 15)

2 had extrusion (12 and 15 months)

NA

2/20 (10%)

Talajic 2012

11 of 32 (34.4%)

NR

NA

Thirty‐one eyes (82%) that underwent KPro surgery displayed postoperative BCVA improvement.

0/32; failure rate 0% (n = 32) with a mean follow‐up time of 16.5 (SD 4.7) months

NR

NA

None

Early model of Boston keratoprosthesis (known as Dohlman‐Doane keratoprosthesis)

Aquavella 2005

NR

NA

NA

12/25 with 20/200 or better; 3/25 with 20/40 or better

NR

NA

NA

None at one year

Harissi‐Dagher 2007

NR

NR

NR

NR

NR

NR

NR

NR

Study

Study design

Study dates

Country

Follow‐up

Number of participants

Number with repeat PK

Funding source and declarations of interest

Hicks 2006

Multicenter surveillance data

1998‐2006

11 countries, including Australia, Singapore, and USA

Mean 15.5 months (range 0.5 to 7.4 years)

302 (304 eyes, 322 devices implanted)

302 (304 eyes, 322 devices implanted)

"Hicks and Crawford have a financial interest with the manufacturer of AlphaCor, CooperVision Surgical, through support of departmental funding, travel and research."

Jiraskova 2011

Retrospective case series

NR

Germany/Czech Republic

Mean 38 months (range 12 to 67 months)

15 (15 eyes)

12/15 (80%)

"Supported in part by research project MZO 00179906
from the Ministry of Health, Prague, Czech Republic."

"The authors declare no conflict of interest."

Trichet 2013

Retrospective case series

2009‐2011

France

Mean 16 months (range 2 to 24 months)

14 (14 eyes)

10/14 (71%)

"Conference invitations as a speaker for Addition Technology, Inc."

Study

Number with BCVA ≥ 20/100

Other visual acuity outcomes

Number of graft failures

Number of device extrusions

1 year

2 years

5 years

1 year

2 years

5 years

Hicks 2006

"41.4% of all post–stage 2 cases achieved 20/200 or better", timing not specified by year

VA achieved postoperatively was LP to 20/20, mean 20/200; "mean improvement of 2 lines"; "6 eyes permanently lost vision over a summed 416 years of follow‐up. This finding equates to an annual risk per eye of 0.014."

NR; failure rate 20% for on‐label use

NR; failure rate 38% for on‐label use

110/322 devices at final follow‐up; failure rate 34.2%

NR

Jiraskova 2011

2 of 13 (15%)

2 of 7 (29%)

NR

NR

NR

NR

NR

NR

Trichet 2013

NR

NR

NA

"Postoperative mean visual acuity gain was 2.5 +/‐ 3.1 lines (from 0 to +11 lines). Visual acuity was superior or equal to 20/200 in 21% of cases."

NR; failure rate 28.6% with mean follow‐up of 15.6 months

NR

NA

1/14 (7%)

Study

Study design

Study dates

Country

Follow‐up

Number of participants

Number with repeat PK

Funding source and declarations of interest

Ghaffariyeh 2011

Retrospective case series of the Fyodorov‐Zuev KPro

2003‐2007

Iran (Dr. Khodadoust Eye Hospital)

Mean 52 months (range 28 to 84 months)

10 (10 eyes)

10/10 (100%)

"None of the authors have any financial or proprietary interest in any material or method mentioned."

Hille 2006

Retrospective case series the OOKP

1993‐2004

Germany (University of

Saarland)

Median 2.9 years

25 (25 eyes)

18/25 (72%)

NR

Study

Number with BCVA ≥ 20/100

Other visual acuity outcomes

Number of graft failures

Number of device extrusions

1 year

2 years

5 years

1 year

2 years

5 years

Ghaffariyeh 2011

8/10

8/10

2/4

"Patients retained BUVA of 20/200–20/50 in 50%, 20/60‐20/ 100 in 30%, 20/200 in 10% and 20/400 in 10% of cases. Overall, 90% had 1 year postoperative vision of 20/200 or better. Eyes had 20/200 or better in 70% of cases at the last follow‐up (average 52 months)."

1/10 (10%)

2/10 (20%)

3/10 (30%) at 3 years; failure rate 30% during follow‐up

3/10 (30%) during follow‐up

Hille 2006

11/20 (55%)

7/14 (50%)

2/5 (40%)

79% achieved ambulatory vision of 20/400 at last follow up

NR

NR

NR

None reported