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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
Sponsor:
Collaborators:
National Eye Institute (NEI)
Jaeb Center for Health Research
Information provided by (Responsible Party):
Jonathan Lass, MD, Case Western Reserve University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Cornea Preservation Time
Endothelial Keratoplasty
Transplant Success
Endothelial Cell Density
Intervention: Biological: Cornea tissue transplant

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization was at eye level. When both eyes of a participant were included, the eye undergoing surgery 1st was assigned randomly to a PT group and the 2nd eye to the other group. 2 eyes had their assigned donor corneas inadvertently switched, and resulted in 1 of these participants receiving both study eyes from 8-14d group.

Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (eyes)

Reporting Groups
  Description
0-7d Preservation Time (PT) Group

Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.

Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.

8-14d Preservation Time (PT) Group

Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.

Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.


Participant Flow:   Overall Study
    0-7d Preservation Time (PT) Group   8-14d Preservation Time (PT) Group
Participants Units (eyes) Participants Units (eyes)
STARTED [1]   707   707   698   699 
COMPLETED [2]   553   553   507   508 
NOT COMPLETED   154      191    
Exclude prior to study                32                                44                 
Death                20                                32                 
Withdrawal by Subject                18                                17                 
Lost to Follow-up                53                                48                 
Failure - Regrafted                28                                43                 
Failure - Not regrafted                2                                6                 
Censored (severe event unrelated to PT)                1                                1                 
[1] 1046 eyes from 1151 participants randomized
[2] Study eyes with 3-year visit completed



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analyses conducted at eye level. 1330 study eyes of 1090 participants underwent descemet stripping automated endothelial keratoplasty. 480 eyes completed bilateral surgery (240 participants), 1 participant had both eyes received cornea in 8-14 days group. 435 and 414 participants underwent unilateral surgery in 0-7 and 8-14 days groups.

Reporting Groups
  Description
Preservation Time Group 1

Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.

Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.

Preservation Time Group 2

Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.

Cornea tissue transplant: Cornea tissue preserved either 7 or less days or 8 to 14 days.

Total Total of all reporting groups

Baseline Measures
   Preservation Time Group 1   Preservation Time Group 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 675   654   1090 
Overall Units Analyzed (Eyes) 
[Units: Eyes]
 675   655   1330 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 70 
 (64 to 76) 
 70 
 (64 to 77) 
 70 
 (64 to 76) 
Sex: Female, Male 
[Units: Eyes]
Count of Units
     
Female      409  60.6%      392  59.8%      801  60.2% 
Male      266  39.4%      263  40.2%      529  39.8% 
Race/Ethnicity, Customized 
[Units: Eyes]
Count of Units
     
White      613  90.8%      594  90.7%      1207  90.8% 
African American      26   3.9%      21   3.2%      47   3.5% 
Hispanic or Latino      19   2.8%      25   3.8%      44   3.3% 
Asian      7   1.0%      5   0.8%      12   0.9% 
American India or Alaskan Native      1   0.1%      2   0.3%      3   0.2% 
More than 1 race      6   0.9%      3   0.5%      9   0.7% 
Unknown or not reported      3   0.4%      5   0.8%      8   0.6% 
History of Diabetes 
[Units: Eyes]
Count of Units
 116   126   242 
Current cigarette smoker 
[Units: Eyes]
Count of Units
 45   45   90 
Received any immunizations or vaccinations in last 3 mo 
[Units: Eyes]
Count of Units
 92   81   173 
Prior glaucoma surgery 
[Units: Eyes]
Count of Units
 18   13   31 
Glaucoma medication currently being used 
[Units: Eyes]
Count of Units
 45   54   99 
Diagnosis 
[Units: Eyes]
Count of Units
     
Pseudophakic corneal edema without FECD      44   6.5%      29   4.4%      73   5.5% 
Aphakic corneal edema without FECD      0   0.0%      2   0.3%      2   0.2% 
Fuchs endothelial corneal dystrophy (FECD)      631  93.5%      624  95.3%      1255  94.4% 
Corneal Dystrophy other than FECD (Fuchs endothelial corneal dystrophy)) [1] 
[Units: Eyes]
Count of Units
     
No      630  93.3%      623  95.1%      1253  94.2% 
Keratoconus      1   0.1%      0   0.0%      1   0.1% 
EBMD (epithelial basement membrane dystrophy)      38   5.6%      29   4.4%      67   5.0% 
Other      6   0.9%      3   0.5%      9   0.7% 
[1] During the slit lamp exam performed using the investigator's usual routine, the presence of other corneal dystrophies was recorded; EBMD=epithelial basement membrane dystrophy
Stromal corneal vessels present (but not visually significant) 
[Units: Eyes]
Count of Units
 4   1   5 
Central subepithelial/stromal scarring present (not affect postoperative stromal clarity assessment) 
[Units: Eyes]
Count of Units
 37   48   85 
Peripheral anterior synechiae present (nongonioscopic) 
[Units: Eyes]
Count of Units
 4   2   6 
Preoperative lens status [1] 
[Units: Eyes]
Count of Units
     
Phakic      341  50.5%      351  53.6%      692  52.0% 
Aphakic      0   0.0%      2   0.3%      2   0.2% 
Pseudophakic posterior chamber intraocular lens      334  49.5%      302  46.1%      636  47.8% 
[1] During the slit lamp exam performed using the investigator's usual routine, the state of the crystalline lens was described as phakic (present), aphakic (removed), or pseudophakic (removed with posterior chamber intraocular lens inserted)
Postoperative lens status 
[Units: Eyes]
Count of Units
     
Phakic      4   0.6%      6   0.9%      10   0.8% 
Pseudophakic posterior chamber intraocular lens      671  99.4%      649  99.1%      1320  99.2% 
Intraocular pressure (IOP) 
[Units: Mm Hg]
Median (Inter-Quartile Range)
 15 
 (12 to 17) 
 15 
 (12 to 17) 
 15 
 (12 to 17) 


  Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Endothelial Cell Density (ECD)   [ Time Frame: 3 years from surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jonathan Lass
Organization: CaseWestern
phone: 2168448368
e-mail: Jonathan.Lass@UHhospitals.org


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jonathan Lass, MD, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01537393     History of Changes
Other Study ID Numbers: CPTS
1U10EY020798-01A1 ( U.S. NIH Grant/Contract )
1U10EY020797-01A1 ( U.S. NIH Grant/Contract )
First Submitted: February 15, 2012
First Posted: February 23, 2012
Results First Submitted: March 14, 2018
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018