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Study of Endothelial Keratoplasty Outcomes

Primary Purpose

Fuchs' Endothelial Corneal Dystrophy, Bullous Keratopathy, Iridocorneal Endothelial Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

endothelial keratoplasty

About this trial

This is an interventional treatment trial for Fuchs' Endothelial Corneal Dystrophy focused on measuring failed penetrating keratoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female aged 18 or older
Scheduled to undergo endothelial keratoplasty
Able to provide written informed consent.

Exclusion Criteria:

Age less than 18 years

Sites / Locations

Price Vision Group

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

Endothelial keratoplasty procedure is performed.

Outcomes

Primary Outcome Measures

Visual acuity

Secondary Outcome Measures

Endothelial cell density

Intraocular pressure

Manifest refraction

corneal pachymetry

Full Information

NCT ID

NCT00800111

First Posted

November 26, 2008

Last Updated

January 21, 2019

Sponsor

Cornea Research Foundation of America

1. Study Identification

Unique Protocol Identification Number

NCT00800111

Brief Title

Study of Endothelial Keratoplasty Outcomes

Official Title

Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

February 2018 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cornea Research Foundation of America

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Endothelial keratoplasty is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. This technique offers many advantages compared with traditional full-thickness cornea transplants. Patients experience minimal change in glasses prescription and usually recover useful vision within weeks. Visual fluctuations are minimal during the healing process. The patient's cornea remains structurally intact and is more resistant to injury. Endothelial keratoplasty is undergoing rapid and widespread adoption. Between 2005 and 2007, the number of corneas placed by US eye banks for endothelial keratoplasty increased ten-fold (2007 Eye Bank Association of America Annual Report). However, the procedure is less than 10 years old, and little is known about long term outcomes. Endothelial keratoplasty candidates at our center are invited to participate in an open enrollment, prospective study of the long-term outcomes of this procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fuchs' Endothelial Corneal Dystrophy, Bullous Keratopathy, Iridocorneal Endothelial Syndrome, Posterior Polymorphous Dystrophy

Keywords

failed penetrating keratoplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2593 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Other

Arm Description

Endothelial keratoplasty procedure is performed.

Intervention Type

Procedure

Intervention Name(s)

endothelial keratoplasty

Other Intervention Name(s)

Descemet stripping endothelial keratoplasty, Descemet stripping automated endothelial keratoplasty, Descemet membrane endothelial keratoplasty, DSEK, DSAEK, DMEK

Intervention Description

Endothelial keratoplasty is surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea).

Primary Outcome Measure Information:

Title

Visual acuity

Time Frame

1, 3, 6, and 12 months and annually

Secondary Outcome Measure Information:

Title

Endothelial cell density

Time Frame

6 months, 12 months and annually

Title

Intraocular pressure

Time Frame

1, 3, 6, 12 months and annually

Title

Manifest refraction

Time Frame

1, 3, 6, 12 months and annually

Title

corneal pachymetry

Time Frame

1, 3, 6, 12 months and annually

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female aged 18 or older Scheduled to undergo endothelial keratoplasty Able to provide written informed consent. Exclusion Criteria: Age less than 18 years

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francis W Price, Jr., MD

Organizational Affiliation

Cornea Research Foundation of America

Official's Role

Principal Investigator

Facility Information:

Facility Name

Price Vision Group

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18329627

Citation

Vajaranant TS, Price MO, Price FW, Wilensky JT, Edward DP. Intraocular pressure measurements following Descemet stripping endothelial keratoplasty. Am J Ophthalmol. 2008 May;145(5):780-6. doi: 10.1016/j.ajo.2008.01.010. Epub 2008 Mar 10.

Results Reference

background

PubMed Identifier

17893530

Citation

Allan BD, Terry MA, Price FW Jr, Price MO, Griffin NB, Claesson M. Corneal transplant rejection rate and severity after endothelial keratoplasty. Cornea. 2007 Oct;26(9):1039-42. doi: 10.1097/ICO.0b013e31812f66e5.

Results Reference

background

PubMed Identifier

17868873

Citation

Price MO, Price FW Jr. Endothelial cell loss after descemet stripping with endothelial keratoplasty influencing factors and 2-year trend. Ophthalmology. 2008 May;115(5):857-65. doi: 10.1016/j.ophtha.2007.06.033. Epub 2007 Sep 14.

Results Reference

background

PubMed Identifier

17568204

Citation

Price MO, Price FW. Descemet's stripping endothelial keratoplasty. Curr Opin Ophthalmol. 2007 Jul;18(4):290-4. doi: 10.1097/ICU.0b013e3281a4775b.

Results Reference

background

PubMed Identifier

17321384

Citation

Price MO, Price FW Jr, Trespalacios R. Endothelial keratoplasty technique for aniridic aphakic eyes. J Cataract Refract Surg. 2007 Mar;33(3):376-9. doi: 10.1016/j.jcrs.2006.10.052.

Results Reference

background

PubMed Identifier

17102663

Citation

Price FW Jr, Price MO. Endothelial keratoplasty to restore clarity to a failed penetrating graft. Cornea. 2006 Sep;25(8):895-9. doi: 10.1097/01.ico.0000227888.03877.22.

Results Reference

background

PubMed Identifier

16935344

Citation

Price MO, Price FW Jr. Descemet's stripping with endothelial keratoplasty: comparative outcomes with microkeratome-dissected and manually dissected donor tissue. Ophthalmology. 2006 Nov;113(11):1936-42. doi: 10.1016/j.ophtha.2006.05.034. Epub 2006 Aug 28.

Results Reference

background

PubMed Identifier

16631048

Citation

Price FW Jr, Price MO. Descemet's stripping with endothelial keratoplasty in 200 eyes: Early challenges and techniques to enhance donor adherence. J Cataract Refract Surg. 2006 Mar;32(3):411-8. doi: 10.1016/j.jcrs.2005.12.078.

Results Reference

background

PubMed Identifier

16128330

Citation

Price FW Jr, Price MO. Descemet's stripping with endothelial keratoplasty in 50 eyes: a refractive neutral corneal transplant. J Refract Surg. 2005 Jul-Aug;21(4):339-45. doi: 10.3928/1081-597X-20050701-07.

Results Reference

background

PubMed Identifier

21872938

Citation

Guerra FP, Anshu A, Price MO, Giebel AW, Price FW. Descemet's membrane endothelial keratoplasty: prospective study of 1-year visual outcomes, graft survival, and endothelial cell loss. Ophthalmology. 2011 Dec;118(12):2368-73. doi: 10.1016/j.ophtha.2011.06.002. Epub 2011 Aug 27.

Results Reference

result

PubMed Identifier

21183511

Citation

Pereira Cda R, Guerra FP, Price FW Jr, Price MO. Descemet's membrane automated endothelial keratoplasty (DMAEK): visual outcomes and visual quality. Br J Ophthalmol. 2011 Jul;95(7):951-4. doi: 10.1136/bjo.2010.191494. Epub 2010 Dec 22.

Results Reference

result

PubMed Identifier

21099412

Citation

McCauley MB, Price MO, Fairchild KM, Price DA, Price FW Jr. Prospective study of visual outcomes and endothelial survival with Descemet membrane automated endothelial keratoplasty. Cornea. 2011 Mar;30(3):315-9. doi: 10.1097/ICO.0b013e3181eeb71b.

Results Reference

result

PubMed Identifier

21993468

Citation

Guerra FP, Anshu A, Price MO, Price FW. Endothelial keratoplasty: fellow eyes comparison of Descemet stripping automated endothelial keratoplasty and Descemet membrane endothelial keratoplasty. Cornea. 2011 Dec;30(12):1382-6. doi: 10.1097/ICO.0b013e31821ddd25.

Results Reference

result

PubMed Identifier

20166622

Citation

Kwon RO, Price MO, Price FW Jr, Ambrosio R Jr, Belin MW. Pentacam characterization of corneas with Fuchs dystrophy treated with Descemet membrane endothelial keratoplasty. J Refract Surg. 2010 Dec;26(12):972-9. doi: 10.3928/1081597X-20100212-08. Epub 2010 Feb 15.

Results Reference

result

PubMed Identifier

19875170

Citation

Price MO, Giebel AW, Fairchild KM, Price FW Jr. Descemet's membrane endothelial keratoplasty: prospective multicenter study of visual and refractive outcomes and endothelial survival. Ophthalmology. 2009 Dec;116(12):2361-8. doi: 10.1016/j.ophtha.2009.07.010. Epub 2009 Oct 28.

Results Reference

result

PubMed Identifier

19781456

Citation

McCauley MB, Price FW Jr, Price MO. Descemet membrane automated endothelial keratoplasty: hybrid technique combining DSAEK stability with DMEK visual results. J Cataract Refract Surg. 2009 Oct;35(10):1659-64. doi: 10.1016/j.jcrs.2009.05.034.

Results Reference

result

PubMed Identifier

23635858

Citation

Feng MT, Burkhart ZN, Price FW Jr, Price MO. Effect of donor preparation-to-use times on Descemet membrane endothelial keratoplasty outcomes. Cornea. 2013 Aug;32(8):1080-2. doi: 10.1097/ICO.0b013e318292a7e5.

Results Reference

result

PubMed Identifier

22710494

Citation

Anshu A, Price MO, Price FW Jr. Descemet stripping automated endothelial keratoplasty for Fuchs endothelial dystrophy-influence of graft diameter on endothelial cell loss. Cornea. 2013 Jan;32(1):5-8. doi: 10.1097/ICO.0b013e318247311a.

Results Reference

result

PubMed Identifier

22710497

Citation

Anshu A, Price MO, Price FW Jr. Descemet membrane endothelial keratoplasty and hybrid techniques for managing failed penetrating grafts. Cornea. 2013 Jan;32(1):1-4. doi: 10.1097/ICO.0b013e3182488888.

Results Reference

result

PubMed Identifier

22705345

Citation

Anshu A, Price MO, Price FW. Descemet's stripping endothelial keratoplasty: long-term graft survival and risk factors for failure in eyes with preexisting glaucoma. Ophthalmology. 2012 Oct;119(10):1982-7. doi: 10.1016/j.ophtha.2012.04.031. Epub 2012 Jun 15.

Results Reference

result

PubMed Identifier

22218143

Citation

Anshu A, Price MO, Price FW Jr. Risk of corneal transplant rejection significantly reduced with Descemet's membrane endothelial keratoplasty. Ophthalmology. 2012 Mar;119(3):536-40. doi: 10.1016/j.ophtha.2011.09.019. Epub 2012 Jan 3.

Results Reference

result

PubMed Identifier

24488132

Citation

Chaurasia S, Price MO, McKee Y, Price FW Jr. Descemet membrane endothelial keratoplasty combined with epithelial debridement and mitomycin-C application for fuchs dystrophy with preoperative subepithelial fibrosis or anterior basement membrane dystrophy. Cornea. 2014 Apr;33(4):335-9. doi: 10.1097/ICO.0000000000000078.

Results Reference

result

PubMed Identifier

24252821

Citation

Chaurasia S, Price FW Jr, Gunderson L, Price MO. Descemet's membrane endothelial keratoplasty: clinical results of single versus triple procedures (combined with cataract surgery). Ophthalmology. 2014 Feb;121(2):454-8. doi: 10.1016/j.ophtha.2013.09.032. Epub 2013 Nov 16.

Results Reference

result

PubMed Identifier

24957432

Citation

Feng MT, Price MO, Miller JM, Price FW Jr. Air reinjection and endothelial cell density in Descemet membrane endothelial keratoplasty: five-year follow-up. J Cataract Refract Surg. 2014 Jul;40(7):1116-21. doi: 10.1016/j.jcrs.2014.04.023.

Results Reference

result

PubMed Identifier

24417895

Citation

Burkhart ZN, Feng MT, Price FW Jr, Price MO. One-year outcomes in eyes remaining phakic after Descemet membrane endothelial keratoplasty. J Cataract Refract Surg. 2014 Mar;40(3):430-4. doi: 10.1016/j.jcrs.2013.08.047. Epub 2014 Jan 11.

Results Reference

result

PubMed Identifier

26096520

Citation

Schoenberg ED, Price FW Jr, Miller J, McKee Y, Price MO. Refractive outcomes of Descemet membrane endothelial keratoplasty triple procedures (combined with cataract surgery). J Cataract Refract Surg. 2015 Jun;41(6):1182-9. doi: 10.1016/j.jcrs.2014.09.042. Epub 2015 Jun 19.

Results Reference

result

PubMed Identifier

26050537

Citation

Price MO, Feng MT, McKee Y, Price FW Jr. Repeat Descemet Membrane Endothelial Keratoplasty: Secondary Grafts with Early Intervention Are Comparable with Fellow-Eye Primary Grafts. Ophthalmology. 2015 Aug;122(8):1639-44. doi: 10.1016/j.ophtha.2015.04.037. Epub 2015 Jun 6.

Results Reference

result

PubMed Identifier

24452215

Citation

Tenkman LR, Price FW, Price MO. Descemet membrane endothelial keratoplasty donor preparation: navigating challenges and improving efficiency. Cornea. 2014 Mar;33(3):319-25. doi: 10.1097/ICO.0000000000000045.

Results Reference

result

PubMed Identifier

28749899

Citation

Price MO, Lisek M, Feng MT, Price FW Jr. Effect of Donor and Recipient Diabetes Status on Descemet Membrane Endothelial Keratoplasty Adherence and Survival. Cornea. 2017 Oct;36(10):1184-1188. doi: 10.1097/ICO.0000000000001305.

Results Reference

result

PubMed Identifier

27560030

Citation

Gonzalez A, Price FW Jr, Price MO, Feng MT. Prevention and Management of Pupil Block After Descemet Membrane Endothelial Keratoplasty. Cornea. 2016 Nov;35(11):1391-1395. doi: 10.1097/ICO.0000000000001015.

Results Reference

result

PubMed Identifier

27158810

Citation

Price DA, Price MO, Lopez A, Price FW Jr. Effect of Descemet Membrane Endothelial Keratoplasty on Color Vision in Patients With Fuchs Dystrophy. Cornea. 2016 Aug;35(8):1045-8. doi: 10.1097/ICO.0000000000000871.

Results Reference

result

PubMed Identifier

27108095

Citation

Price MO, Calhoun P, Kollman C, Price FW Jr, Lass JH. Descemet Stripping Endothelial Keratoplasty: Ten-Year Endothelial Cell Loss Compared with Penetrating Keratoplasty. Ophthalmology. 2016 Jul;123(7):1421-7. doi: 10.1016/j.ophtha.2016.03.011. Epub 2016 Apr 20.

Results Reference

result

PubMed Identifier

26983976

Citation

Price MO, Scanameo A, Feng MT, Price FW Jr. Descemet's Membrane Endothelial Keratoplasty: Risk of Immunologic Rejection Episodes after Discontinuing Topical Corticosteroids. Ophthalmology. 2016 Jun;123(6):1232-6. doi: 10.1016/j.ophtha.2016.02.001. Epub 2016 Mar 13.

Results Reference

result

PubMed Identifier

29525615

Citation

Crews JW, Price MO, Lautert J, Feng MT, Price FW Jr. Intraoperative hyphema in Descemet membrane endothelial keratoplasty alone or combined with phacoemulsification. J Cataract Refract Surg. 2018 Feb;44(2):198-201. doi: 10.1016/j.jcrs.2017.11.015. Epub 2018 Mar 7.

Results Reference

result

PubMed Identifier

29731147

Citation

Price DA, Kelley M, Price FW Jr, Price MO. Five-Year Graft Survival of Descemet Membrane Endothelial Keratoplasty (EK) versus Descemet Stripping EK and the Effect of Donor Sex Matching. Ophthalmology. 2018 Oct;125(10):1508-1514. doi: 10.1016/j.ophtha.2018.03.050. Epub 2018 May 3.

Results Reference

result

Links:

URL

http://www.cornea.org

Description

Cornea Research Foundation of America website

Learn more about this trial

Study of Endothelial Keratoplasty Outcomes

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