Fuchs' Endothelial Corneal DystrophyNCT00800111
Study of Endothelial Keratoplasty Outcomes
A study testing endothelial keratoplasty in people with Fuchs' Endothelial Corneal Dystrophy and Bullous Keratopathy, run by Cornea Research Foundation of America at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs' Endothelial Corneal Dystrophy, Bullous Keratopathy, Iridocorneal Endothelial Syndrome
- What is being tested?
- endothelial keratoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,593 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 or older
- Scheduled to undergo endothelial keratoplasty
- Able to provide written informed consent.
Who cannot join
- Age less than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes
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.
- Conditions
- Fuchs' Endothelial Corneal Dystrophy, Bullous Keratopathy, Iridocorneal Endothelial Syndrome, Posterior Polymorphous Dystrophy
- Being tested
- endothelial keratoplasty
- Keywords
- failed penetrating keratoplasty
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Iridocorneal Endothelial Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endothelial keratoplastyProcedure or surgery
Also called Descemet stripping endothelial keratoplasty, Descemet stripping automated endothelial keratoplasty, Descemet membrane endothelial keratoplasty, DSEK
Endothelial keratoplasty is surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea).
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Endothelial keratoplasty procedure is performed. Receives: Procedure: endothelial keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 1, 3, 6, and 12 months and annually
Secondary outcomes (4)
Endothelial cell density
Measured: 6 months, 12 months and annually
Intraocular pressure
Measured: 1, 3, 6, 12 months and annually
Manifest refraction
Measured: 1, 3, 6, 12 months and annually
corneal pachymetry
Measured: 1, 3, 6, 12 months and annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Fuchs' Endothelial Corneal DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,593 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornea Research Foundation of America
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis W Price, Jr., MD, Principal investigator, Cornea Research Foundation of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800111
- Sponsor's protocol ID
- CRFA2008-01
- Status last verified
- Jan 2019
- First submitted
- 26 Nov 2008
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18329627Allan 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.
PubMed 17893530Price 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.
PubMed 17868873Price MO, Price FW. Descemet's stripping endothelial keratoplasty. Curr Opin Ophthalmol. 2007 Jul;18(4):290-4. doi: 10.1097/ICU.0b013e3281a4775b.
PubMed 17568204Price 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.
PubMed 17321384Price 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.
PubMed 17102663Price 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.
PubMed 16935344Price 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.
PubMed 16631048Price 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.
PubMed 16128330Guerra 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.
PubMed 21872938Pereira 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.
PubMed 21183511McCauley 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.
PubMed 21099412Guerra 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.
PubMed 21993468Kwon 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.
PubMed 20166622Price 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.
PubMed 19875170
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes
- ClinicalTrials.gov ID
- NCT00800111
- Acronym / sponsor ID
- CRFA2008-01
- Conditions
- Fuchs' Endothelial Corneal Dystrophy, Bullous Keratopathy, Iridocorneal Endothelial Syndrome, Posterior Polymorphous Dystrophy
- Keywords
- failed penetrating keratoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,593 participants (actual)
- Lead sponsor
- Cornea Research Foundation of AmericaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 1 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Procedure: endothelial keratoplastyEndothelial keratoplasty procedure is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 18 or older
- Scheduled to undergo endothelial keratoplasty
- Able to provide written informed consent.
Key exclusion criteria (1 listed)
- Age less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endothelial keratoplastyAlso: Descemet stripping endothelial keratoplasty, Descemet stripping automated endothelial keratoplasty, Descemet membrane endothelial keratoplasty, DSEKEndothelial keratoplasty is surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea). | Procedure or surgery | Treatment |
Primary outcome
Visual acuity
Time frame: 1, 3, 6, and 12 months and annually
4 secondary outcomes
Endothelial cell density
Time frame: 6 months, 12 months and annually
Intraocular pressure
Time frame: 1, 3, 6, 12 months and annually
Manifest refraction
Time frame: 1, 3, 6, 12 months and annually
corneal pachymetry
Time frame: 1, 3, 6, 12 months and annually
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Background: PubMed 18329627Vajaranant 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.
- Background: PubMed 17893530Allan 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.
- Background: PubMed 17868873Price 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.
- Background: PubMed 17568204Price MO, Price FW. Descemet's stripping endothelial keratoplasty. Curr Opin Ophthalmol. 2007 Jul;18(4):290-4. doi: 10.1097/ICU.0b013e3281a4775b.
- Background: PubMed 17321384Price 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.
- Background: PubMed 17102663Price 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.
- Background: PubMed 16935344Price 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.
- Background: PubMed 16631048Price 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.
- Background: PubMed 16128330Price 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 publication: PubMed 21872938Guerra 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 publication: PubMed 21183511Pereira 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 publication: PubMed 21099412McCauley 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.
- Cornea Research Foundation of America websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis W Price, Jr., MD principal investigator
Cornea Research Foundation of America
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endothelial keratoplasty in people with Fuchs' Endothelial Corneal Dystrophy and Bullous Keratopathy, run by Cornea Research Foundation of America at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 1, 3, 6, and 12 months and annually). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00800111, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.