Cornea Preservation Time Study (CPTS)
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ClinicalTrials.gov Identifier: NCT01537393 |
Recruitment Status :
Completed
First Posted : February 23, 2012
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
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Condition or disease | Intervention/treatment | Phase |
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Cornea Preservation Time Endothelial Keratoplasty Transplant Success Endothelial Cell Density | Biological: Cornea tissue transplant | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1174 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of Corneal Preservation Time on Long-Term Graft Success |
Actual Study Start Date : | April 16, 2012 |
Actual Primary Completion Date : | June 30, 2017 |
Actual Study Completion Date : | June 30, 2017 |

Arm | Intervention/treatment |
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0-7d Preservation Time Group
Subjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 0 to 7 days prior to transplant.
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Biological: Cornea tissue transplant
Cornea tissue preserved 0 to 7 days |
8-14d Preservation Time Group
Subjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 8 to 14 days prior to transplant.
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Biological: Cornea tissue transplant
Cornea tissue preserved 8 to 14 days. |
- Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery [ Time Frame: Study eye will be assessed for this outcome for 3 years following surgery ]
Graft failure, defined as the occurrence of one of the following within 3 years of surgery:
- Regrafting of the study eye for any reason
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Cornea which remains cloudy without clearing, according to the following:
- cloudy cornea on the first postoperative day which does not clear within 8 weeks OR
- cloudy cornea which was initially clear postoperatively but becomes and remains cloudy for 3 months without clearing.
- Endothelial Cell Density (ECD) [ Time Frame: 3 years from surgery ]Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Study Participant Eligibility Criteria
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Study Participant Inclusion Criteria
- Age range 30-<91 years with minimum life expectancy of at least 3 years.
- Willingness to return for follow-up study visits at 1 day, 1 week, 1 month, 6 months, 1 year, 2 years and 3 years.
- Fluent in English or Spanish.
- Study Participant Exclusion Criteria 1) Decisionally and/or cognitively impaired
Study Eye Eligibility Criteria
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Study Eye Inclusion Criteria
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Endothelial keratoplasty (EK) is scheduled between 10 and 60 days after enrollment
- The 10-day requirement relates to the need to be able to randomly assign the eye to either intervention group.
- The 60-day requirement relates to the need to have current eligibility and enrollment data at the time of surgery. If surgery is postponed to >60 days after the initial enrollment visit, a new Baseline Visit and eligibility assessment will have to be performed.
- Presence of a condition related to endothelial dysfunction which will be treated by EK.
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Eligible indications for EK include:
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Presence of Fuchs endothelial corneal dystrophy (FECD) meeting at least one of the following:
- Phakic FECD
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Phakic FECD with cataract
- Triple procedure including EK for FECD, cataract extraction and posterior chamber intraocular lens implantation (IOL) is allowed
- Aphakic FECD
- Pseudophakic FECD with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber IOL
- Aphakic or pseudophakic corneal edema with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber IOL without FECD
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Study Eye Exclusion Criteria
- Prior EK
- Indication for surgery that is not suitable for EK (e.g, keratoconus, stromal dystrophies and scars)
- Presence of a condition that has a very high probability for failure (e.g., failed EK or Penetrating Keratoplasty (PKP), heavily vascularized cornea, uncontrolled uveitis)
- Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy
- Anterior chamber IOL in study eye prior to or anticipated during EK
- Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber IOL in study eye at time of study EK
- Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment
- Stromal vascularization that is visually significant (by investigator's judgment)
- Presence of anterior synechiae (iris to cornea)
- Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
- Hypotony (Intraocular pressure <10 mm Hg)
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Uncontrolled (defined as intraocular pressure > 25mm Hg) glaucoma with or without prior filtering surgery or shunt or mini-shunt placement.
- A shunt or mini-shunt is any device implanted to lower intraocular pressure through an external route (e.g Ahmed) or internal route (e.g. Glaukos) that is present in the anterior chamber angle or extends into the anterior chamber.
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Controlled glaucoma with prior shunt or mini-shunt placement for glaucoma
- Note: FECD or pseudophakic/aphakic corneal edema with posterior chamber IOL that also have undergone filtering surgery (without shunt or mini-shunt) in which glaucoma is currently considered under control will be eligible
- Fellow eye visual acuity < 20/200 that is not correctable with EK
Eligibility Criteria for Second Study Eye
- Study participant has already enrolled one eye
- The second eye meets all study eye inclusion and exclusion criteria (2.2.2 and 2.2.3)
- EK surgery in second eye is not planned within 6 weeks of EK on first study eye

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537393

Study Chair: | Jonathan Lass, MD | Case Western Reserve University | |
Principal Investigator: | Allison Ayala, MS | Jaeb Center for Health Research |
Documents provided by Jonathan Lass, MD, Case Western Reserve University:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jonathan Lass, MD, Charles I Thomas Professor, Dept. of Ophthalmology & Visual Sciences,, Case Western Reserve University |
ClinicalTrials.gov Identifier: | NCT01537393 |
Other Study ID Numbers: |
CPTS 1U10EY020798-01A1 ( U.S. NIH Grant/Contract ) 1U10EY020797-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | February 23, 2012 Key Record Dates |
Results First Posted: | April 23, 2018 |
Last Update Posted: | April 23, 2018 |
Last Verified: | April 2018 |
cornea transplant preservation endothelial keratoplasty |
Corneal Diseases Eye Diseases |