Keratoplasty, Grafting, Corneal, Transplantation, Corneal, Transplantation, Cornea, Keratoplasty, Lamellar
Conditions
Brief summary
The purpose of this study is to compare visual acuity outcomes of two types of endothelial keratoplasty: 1) Ultrathin Descemet's Stripping Endothelial Keratoplasty (DSAEK) or 2) Descemet's Membrane Endothelial Keratoplasty (DMEK). Half of the participants will be randomized to have DSAEK and the other half will have DMEK.
Detailed description
Corneal transplantation has evolved rapidly in recent years. Lamellar keratoplasty to replace diseased endothelium has led to faster recovery times, fewer complications, and better visual acuity outcomes. Currently, Descemet's Stripping Endothelial Keratoplasty (DSAEK) is the most common procedure because of its relative ease and good outcomes. Newer techniques such as Descemet's Membrane Endothelial Keratoplasty (DMEK), where Descemet's membrane alone is transplanted, has the potential to further improve visual acuity outcomes, produce fewer higher-order corneal aberrations and decrease rejection rates. However, donor preparation, increased intra-operative times, and problems with donor attachment in DMEK are all important limitations. There are three potential mechanisms by which DMEK may provide better visual acuity outcomes than DSAEK; graft thickness, interface haze and corneal higher-order aberrations. Graft thickness has been correlated with best spectacle corrected visual acuity (BSCVA) outcomes among thinner grafts. One retrospective case series found that 71% of thin endothelial grafts (defined as \<131μm) had BSCVA of 20/25 or better while only 50% of thick grafts (defined as ≥131) achieved this. In addition, higher-order aberrations, in particular of the posterior cornea, are increased after DSAEK. Theoretically, given the decreased tissue transplanted after DMEK this would be lessened, however, one retrospective series looking at higher order aberrations in DMEK compared with DSAEK found no difference in posterior aberrations of the central 4.0 mm zone between the two groups. Finally, interface haze may be increased in DSAEK and has been correlated with BSCVA. Ultrathin DSAEK involves donor preparation with a deep microkeratome pass to produce donor grafts less than 100 um thick. This procedure may have similar results to DMEK but without the technical difficulties. Several large prospective series show similar visual outcome results and rates of immunologic rejection between ultrathin DSAEK and DMEK, however comparisons are difficult. This comparative effectiveness clinical trial could directly address these important issues. The investigators also anticipate that secondary analyses of the trial data will allow us to address several more.
Interventions
PROCEDUREDSAEK
PROCEDUREDMEK
DEVICEEndoserter
The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.
DRUGPrednisolone
Prednisolone is a corticosteroid used to alleviate swelling post-surgery.
DRUGOfloxacin
Ofloxacin is an antibiotic used to treat bacterial infections of the eye.
DRUGTropicamide
Tropicamide is a prescription drug used to dilate pupils during an eye exam.
DRUGPhenylephrine
Phenylephrine is a prescription drug used to dilate pupils during an eye exam.
DEVICEJones Tube
The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Sponsors
University of California, San Francisco
Stanford University
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Damaged or diseased endothelium from Fuchs or Pseudophakic Bullous Keratopathy * Good candidates for corneal transplantation for either DMEK or DSAEK * Willingness and ability to undergo a cornea transplantation * Willingness to participate in follow-up visits
Exclusion criteria
* Participants who are decisionally and/or cognitively impaired * Participants who are not suitable for the DMEK or DSAEK surgeries * Prior Endothelial Keratoplasty (EK) or any other ophthalmic surgery except uncomplicated cataract surgery * Indication for surgery that is not suitable for EK (e.g. keratoconus, stromal dystrophies and scars) * Presence of a condition that increases the probability for failure (e.g., heavily vascularized cornea, uncontrolled uveitis) * Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy * Aphakia, or anterior chamber intraocular lens (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 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 * Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours * Hypotony (Intraocular pressure \<10mmHg) * Uncontrolled (defined as intraocular pressure \>25mmHg) glaucoma Visually significant optic nerve or macular pathology * Visually significant optic nerve or macular pathology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Spectacle-Corrected Visual Acuity | 6 months | The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Spectacle-Corrected Visual Acuity | 3 and 12 months | The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL). |
| Endothelial Cell Count | 3, 6, 12 months | — |
| Corneal Higher-Order Aberrations | 3, 6, 12 months | Corneal anterior and posterior surface higher-order aberrations (HOA) were measured with Scheimpflug imaging (Pentacam) before surgery and at 3, 6, and 12 months post-operatively. Zernike orders 3-8 were calculated at 4.0- and 6.0-mm-diameter optical zones. The results reported here represent total HOA (Sum of Zernike orders 3-8). Note a single observation was not available for one eye in the DMEK group at 6 months, this was analyzed with last observation carried forward. |
| Interface Haze | 3, 6, 12 months | As measured by Pentacam densitometry |
| National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ) | Baseline, 12 months | The National Eye Institute has developed the validated Visual Functioning Questionnaire (NEI-VFQ) to assess the effect of ocular conditions and vision on patient quality of life. The answers to the questionnaire are transformed into sub-scales, including: general health, general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision. Participants are assigned a numerical value for each sub-scale based on their answers between 0-100, where higher numbers indicate better visual function. These sub-scales are then combined according to National Eye Institute guidelines into an overall composite score for each participant. This overall composite score is also on a scale of 0-100, where higher numbers indicate better visual function. Composite score based on National Eye Institute guidelines. |
| Graft Failure/Graft Rejection | Baseline 12 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Operative Times | Baseline | — |
| Adverse Events/Complication Rates | 3, 6, 12, 24 months | composite measure |
| Graft Thickness | 3, 6, 12, 24 months | As measured by Optical coherence tomography (OCT) and Pachymetry |
| Refraction | 3, 6, 12, 24 months | Manifest refraction using phoropter |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| UT-DSAEK Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose.
UT-DSAEK
Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.
Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery.
Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye.
Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam.
Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. | 19 |
| UT-DSAEK Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose.
UT-DSAEK
Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.
Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery.
Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye.
Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam.
Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. | 25 |
| DMEK Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft.
DMEK
Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery.
Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye.
Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam.
Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.
Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery. | 19 |
| DMEK Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft.
DMEK
Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery.
Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye.
Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam.
Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.
Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery. | 25 |
| Total | 88 |
Baseline characteristics
| Characteristic | UT-DSAEK | DMEK | Total |
|---|---|---|---|
| Age, Continuous | 68 years | 68 years | 68 years |
| Best Spectacle-Corrected Visual Acuity (logMAR) | 0.27 logMAR STANDARD_DEVIATION 0.21 | 0.34 logMAR STANDARD_DEVIATION 0.29 | 0.30 logMAR STANDARD_DEVIATION 0.25 |
| Central Corneal Thickness | 610 microns STANDARD_DEVIATION 44 | 608 microns STANDARD_DEVIATION 52 | 609 microns STANDARD_DEVIATION 48 |
| Diagnosis Fuch's Dystrophy | 24 eyes | 24 eyes | 48 eyes |
| Diagnosis Pseudophakic Bullous Keratopathy | 1 eyes | 1 eyes | 2 eyes |
| Donor Age | 64 years | 62 years | 63 years |
| Donor Central Graft Thickness (UT-DSAEK only) | 73 mm | NA mm | 73 mm |
| Donor Death to Preservation Time | 9 hours STANDARD_DEVIATION 4 | 9 hours STANDARD_DEVIATION 3 | 9 hours STANDARD_DEVIATION 4 |
| Donor Death to Surgery Time | 6 days STANDARD_DEVIATION 1 | 6 days STANDARD_DEVIATION 1 | 6 days STANDARD_DEVIATION 1 |
| Donor Endothelial Cell Count (post-processing) | 2796 cells/mm^2 STANDARD_DEVIATION 238 | 2771 cells/mm^2 STANDARD_DEVIATION 150 | 2783 cells/mm^2 STANDARD_DEVIATION 197 |
| Donor Endothelial Cell Count (pre-processing) | 2792 cells/mm^2 STANDARD_DEVIATION 210 | 2797 cells/mm^2 STANDARD_DEVIATION 222 | 2795 cells/mm^2 STANDARD_DEVIATION 214 |
| Donor Sex Female | 8 eyes | 5 eyes | 13 eyes |
| Donor Sex Male | 17 eyes | 20 eyes | 37 eyes |
| Race (NIH/OMB) American Indian or Alaska Native | 0 eyes | 0 eyes | 0 eyes |
| Race (NIH/OMB) Asian | 1 eyes | 1 eyes | 2 eyes |
| Race (NIH/OMB) Black or African American | 0 eyes | 0 eyes | 0 eyes |
| Race (NIH/OMB) More than one race | 0 eyes | 0 eyes | 0 eyes |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 eyes | 0 eyes | 0 eyes |
| Race (NIH/OMB) Unknown or Not Reported | 0 eyes | 0 eyes | 0 eyes |
| Race (NIH/OMB) White | 24 eyes | 24 eyes | 48 eyes |
| Region of Enrollment United States | 25 eyes | 25 eyes | 50 eyes |
| Sex: Female, Male Female | 16 eyes | 13 eyes | 29 eyes |
| Sex: Female, Male Male | 9 eyes | 12 eyes | 21 eyes |
| Spherical Equivalent | -0.4 diopters STANDARD_DEVIATION 1.9 | -0.8 diopters STANDARD_DEVIATION 2.2 | -0.6 diopters STANDARD_DEVIATION 2 |
| Surgery Pseudophakic Endothelial Keratoplasty | 8 eyes | 7 eyes | 15 eyes |
| Surgery Triple Endothelial Keratoplasty | 17 eyes | 18 eyes | 35 eyes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 9 / 25 | 7 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Best Spectacle-Corrected Visual Acuity
The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL).
Time frame: 6 months
Population: One patient lost to followup
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UT-DSAEK | Best Spectacle-Corrected Visual Acuity | 0.22 logMAR | Standard Deviation 0.16 |
| DMEK | Best Spectacle-Corrected Visual Acuity | 0.05 logMAR | Standard Deviation 0.11 |
p-value: <0.00195% CI: [-2.8, -1]Regression, Linear
Secondary
Best Spectacle-Corrected Visual Acuity
The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL).
Time frame: 24 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UT-DSAEK | Best Spectacle-Corrected Visual Acuity | 0.15 LogMar | Standard Deviation 0.15 |
| DMEK | Best Spectacle-Corrected Visual Acuity | 0.09 LogMar | Standard Deviation 0.16 |
Secondary
Best Spectacle-Corrected Visual Acuity
The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL).
Time frame: 3 and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UT-DSAEK | Best Spectacle-Corrected Visual Acuity | 3 Months | 0.24 logMAR | Standard Deviation 0.21 |
| UT-DSAEK | Best Spectacle-Corrected Visual Acuity | 12 Months | 0.16 logMAR | Standard Deviation 0.18 |
| DMEK | Best Spectacle-Corrected Visual Acuity | 3 Months | 0.11 logMAR | Standard Deviation 0.13 |
| DMEK | Best Spectacle-Corrected Visual Acuity | 12 Months | 0.04 logMAR | Standard Deviation 0.12 |
Comparison: Comparison of 3-Month Visual Acuity Between Groupsp-value: 0.00295% CI: [-2.5, -0.6]Regression, Linear
Comparison: Comparison of 12 Month Visual Acuity Between Groupsp-value: <0.00195% CI: [-2.2, -0.7]Regression, Linear
Secondary
Corneal Higher-Order Aberrations
Corneal anterior and posterior surface higher-order aberrations (HOA) were measured with Scheimpflug imaging (Pentacam) before surgery and at 3, 6, and 12 months post-operatively. Zernike orders 3-8 were calculated at 4.0- and 6.0-mm-diameter optical zones. The results reported here represent total HOA (Sum of Zernike orders 3-8). Note a single observation was not available for one eye in the DMEK group at 6 months, this was analyzed with last observation carried forward.
Time frame: 3, 6, 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UT-DSAEK | Corneal Higher-Order Aberrations | 3 Months Anterior Cornea 4.0-mm | 0.274 root mean square in micrometers | Standard Deviation 0.223 |
| UT-DSAEK | Corneal Higher-Order Aberrations | 6 Months Anterior Cornea 4.0-mm | 0.230 root mean square in micrometers | Standard Deviation 0.11 |
| UT-DSAEK | Corneal Higher-Order Aberrations | 12 Months Anterior Cornea 6.0-mm | 0.725 root mean square in micrometers | Standard Deviation 0.344 |
| UT-DSAEK | Corneal Higher-Order Aberrations | 3 Months Posterior Cornea 4.0-mm | 0.217 root mean square in micrometers | Standard Deviation 0.11 |
| UT-DSAEK | Corneal Higher-Order Aberrations | 3 Months Anterior Cornea 6.0-mm | 0.897 root mean square in micrometers | Standard Deviation 0.8 |
| UT-DSAEK | Corneal Higher-Order Aberrations | 3 Months Posterior Cornea 6.0-mm | 0.621 root mean square in micrometers | Standard Deviation 0.308 |
| UT-DSAEK | Corneal Higher-Order Aberrations | 6 Months Posterior Cornea 4.0-mm | 0.179 root mean square in micrometers | Standard Deviation 0.067 |
| UT-DSAEK | Corneal Higher-Order Aberrations | 6 Months Anterior Cornea 6.0-mm | 0.739 root mean square in micrometers | Standard Deviation 0.371 |
| UT-DSAEK | Corneal Higher-Order Aberrations | 6 Months Posterior Cornea 6.0-mm | 0.505 root mean square in micrometers | Standard Deviation 0.217 |
| UT-DSAEK | Corneal Higher-Order Aberrations | 12 Months Anterior Cornea 4.0-mm | 0.228 root mean square in micrometers | Standard Deviation 0.108 |
| UT-DSAEK | Corneal Higher-Order Aberrations | 12 Months Posterior Cornea 4.0-mm | 0.159 root mean square in micrometers | Standard Deviation 0.068 |
| UT-DSAEK | Corneal Higher-Order Aberrations | 12 Months Posterior Cornea 6.0-mm | 0.459 root mean square in micrometers | Standard Deviation 0.206 |
| DMEK | Corneal Higher-Order Aberrations | 12 Months Anterior Cornea 4.0-mm | 0.241 root mean square in micrometers | Standard Deviation 0.1 |
| DMEK | Corneal Higher-Order Aberrations | 3 Months Posterior Cornea 6.0-mm | 0.346 root mean square in micrometers | Standard Deviation 0.153 |
| DMEK | Corneal Higher-Order Aberrations | 6 Months Posterior Cornea 6.0-mm | 0.288 root mean square in micrometers | Standard Deviation 0.089 |
| DMEK | Corneal Higher-Order Aberrations | 6 Months Anterior Cornea 4.0-mm | 0.243 root mean square in micrometers | Standard Deviation 0.1 |
| DMEK | Corneal Higher-Order Aberrations | 12 Months Posterior Cornea 4.0-mm | 0.098 root mean square in micrometers | Standard Deviation 0.028 |
| DMEK | Corneal Higher-Order Aberrations | 6 Months Posterior Cornea 4.0-mm | 0.095 root mean square in micrometers | Standard Deviation 0.031 |
| DMEK | Corneal Higher-Order Aberrations | 12 Months Anterior Cornea 6.0-mm | 0.723 root mean square in micrometers | Standard Deviation 0.328 |
| DMEK | Corneal Higher-Order Aberrations | 3 Months Anterior Cornea 4.0-mm | 0.288 root mean square in micrometers | Standard Deviation 0.104 |
| DMEK | Corneal Higher-Order Aberrations | 12 Months Posterior Cornea 6.0-mm | 0.284 root mean square in micrometers | Standard Deviation 0.073 |
| DMEK | Corneal Higher-Order Aberrations | 3 Months Posterior Cornea 4.0-mm | 0.116 root mean square in micrometers | Standard Deviation 0.056 |
| DMEK | Corneal Higher-Order Aberrations | 6 Months Anterior Cornea 6.0-mm | 0.724 root mean square in micrometers | Standard Deviation 0.337 |
| DMEK | Corneal Higher-Order Aberrations | 3 Months Anterior Cornea 6.0-mm | 0.829 root mean square in micrometers | Standard Deviation 0.367 |
Secondary
Corneal Higher-Order Aberrations
As measured by Pentacam
Time frame: 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UT-DSAEK | Corneal Higher-Order Aberrations | 24 Months Anterior Cornea 4.0-mm | 0.215 root mean square in micrometers | Standard Deviation 0.136 |
| UT-DSAEK | Corneal Higher-Order Aberrations | 24 Months Posterior Cornea 4.0-mm | 0.155 root mean square in micrometers | Standard Deviation 0.075 |
| UT-DSAEK | Corneal Higher-Order Aberrations | 24 Months Anterior Cornea 6.0-mm | 0.707 root mean square in micrometers | Standard Deviation 0.389 |
| UT-DSAEK | Corneal Higher-Order Aberrations | 24 Months Posterior Cornea 6.0-mm | 0.450 root mean square in micrometers | Standard Deviation 0.216 |
| DMEK | Corneal Higher-Order Aberrations | 24 Months Posterior Cornea 6.0-mm | 0.260 root mean square in micrometers | Standard Deviation 0.008 |
| DMEK | Corneal Higher-Order Aberrations | 24 Months Anterior Cornea 4.0-mm | 0.211 root mean square in micrometers | Standard Deviation 0.008 |
| DMEK | Corneal Higher-Order Aberrations | 24 Months Anterior Cornea 6.0-mm | 0.679 root mean square in micrometers | Standard Deviation 0.314 |
| DMEK | Corneal Higher-Order Aberrations | 24 Months Posterior Cornea 4.0-mm | 0.086 root mean square in micrometers | Standard Deviation 0.029 |
Secondary
Endothelial Cell Count
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UT-DSAEK | Endothelial Cell Count | 1626 cells/mm^2 | Standard Deviation 362 |
| DMEK | Endothelial Cell Count | 1400 cells/mm^2 | Standard Deviation 498 |
Secondary
Endothelial Cell Count
Time frame: 3, 6, 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UT-DSAEK | Endothelial Cell Count | 3 Months | 2114 cells/mm^2 | Standard Deviation 357 |
| UT-DSAEK | Endothelial Cell Count | 6 Months | 2113 cells/mm^2 | Standard Deviation 301 |
| UT-DSAEK | Endothelial Cell Count | 12 Months | 2070 cells/mm^2 | Standard Deviation 292 |
| DMEK | Endothelial Cell Count | 3 Months | 2037 cells/mm^2 | Standard Deviation 495 |
| DMEK | Endothelial Cell Count | 6 Months | 1963 cells/mm^2 | Standard Deviation 425 |
| DMEK | Endothelial Cell Count | 12 Months | 1855 cells/mm^2 | Standard Deviation 448 |
p-value: 0.5395% CI: [-326, 172]t-test, 2 sided
p-value: 0.1795% CI: [-356, 66]t-test, 2 sided
p-value: 0.05195% CI: [-430, -0.4]t-test, 2 sided
Secondary
Graft Failure/Graft Rejection
Time frame: Baseline to 24 months
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| UT-DSAEK | Graft Failure/Graft Rejection | Graft Rejection | 0 eyes |
| UT-DSAEK | Graft Failure/Graft Rejection | Graft Failure | 1 eyes |
| UT-DSAEK | Graft Failure/Graft Rejection | Eyes with No Graft Failure or Rejection | 24 eyes |
| DMEK | Graft Failure/Graft Rejection | Graft Rejection | 0 eyes |
| DMEK | Graft Failure/Graft Rejection | Graft Failure | 1 eyes |
| DMEK | Graft Failure/Graft Rejection | Eyes with No Graft Failure or Rejection | 24 eyes |
Secondary
Graft Failure/Graft Rejection
Time frame: Baseline 12 months
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| UT-DSAEK | Graft Failure/Graft Rejection | Graft Rejection | 0 eyes |
| UT-DSAEK | Graft Failure/Graft Rejection | Graft Failure | 1 eyes |
| DMEK | Graft Failure/Graft Rejection | Graft Rejection | 0 eyes |
| DMEK | Graft Failure/Graft Rejection | Graft Failure | 1 eyes |
Secondary
Interface Haze
As measured by Pentacam densitometry
Time frame: 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UT-DSAEK | Interface Haze | Mild Interface Haze at 24 months | 0 eyes |
| UT-DSAEK | Interface Haze | Moderate Interface Haze at 24 months | 1 eyes |
| UT-DSAEK | Interface Haze | Severe Interface Haze at 24 months | 0 eyes |
| DMEK | Interface Haze | Mild Interface Haze at 24 months | 0 eyes |
| DMEK | Interface Haze | Moderate Interface Haze at 24 months | 0 eyes |
| DMEK | Interface Haze | Severe Interface Haze at 24 months | 0 eyes |
Secondary
Interface Haze
As measured by Pentacam densitometry
Time frame: 3, 6, 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UT-DSAEK | Interface Haze | Moderate Interface Haze at 3 months | 0 eyes |
| UT-DSAEK | Interface Haze | Severe Interface Haze at 6 months | 0 eyes |
| UT-DSAEK | Interface Haze | Mild Interface Haze at 6 months | 2 eyes |
| UT-DSAEK | Interface Haze | Mild Interface Haze at 12 months | 0 eyes |
| UT-DSAEK | Interface Haze | Severe Interface Haze at 3 months | 0 eyes |
| UT-DSAEK | Interface Haze | oderate Interface Haze at 12 months | 0 eyes |
| UT-DSAEK | Interface Haze | oderate Interface Haze at 6 months | 1 eyes |
| UT-DSAEK | Interface Haze | Severe Interface Haze at 12 months | 0 eyes |
| UT-DSAEK | Interface Haze | Mild Interface Haze at 3 months | 2 eyes |
| DMEK | Interface Haze | Severe Interface Haze at 12 months | 0 eyes |
| DMEK | Interface Haze | Mild Interface Haze at 3 months | 1 eyes |
| DMEK | Interface Haze | Moderate Interface Haze at 3 months | 0 eyes |
| DMEK | Interface Haze | Severe Interface Haze at 3 months | 0 eyes |
| DMEK | Interface Haze | Mild Interface Haze at 6 months | 1 eyes |
| DMEK | Interface Haze | oderate Interface Haze at 6 months | 0 eyes |
| DMEK | Interface Haze | Severe Interface Haze at 6 months | 0 eyes |
| DMEK | Interface Haze | Mild Interface Haze at 12 months | 0 eyes |
| DMEK | Interface Haze | oderate Interface Haze at 12 months | 0 eyes |
Secondary
National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ)
The National Eye Institute has developed the validated Visual Functioning Questionnaire (NEI-VFQ) to assess the effect of ocular conditions and vision on patient quality of life. The answers to the questionnaire are transformed into sub-scales, including: general health, general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision. Participants are assigned a numerical value for each sub-scale based on their answers between 0-100, where higher numbers indicate better visual function. These sub-scales are then combined according to National Eye Institute guidelines into an overall composite score for each participant. This overall composite score is also on a scale of 0-100, where higher numbers indicate better visual function. Composite score based on National Eye Institute guidelines.
Time frame: Baseline, 12 months
Population: For this analysis, all second eyes (enrolled eyes belonging to a patient that had enrolled their other eye and already had surgery on that eye as part of this study) were removed. For this reason the total number of eyes equals the total number of participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UT-DSAEK | National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ) | Baseline | 72.5 Composite scores on a scale | Standard Deviation 13.4 |
| UT-DSAEK | National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ) | 12 Months | 85.9 Composite scores on a scale | Standard Deviation 9.1 |
| DMEK | National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ) | Baseline | 72.3 Composite scores on a scale | Standard Deviation 15.2 |
| DMEK | National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ) | 12 Months | 87.3 Composite scores on a scale | Standard Deviation 9.5 |
p-value: 0.7t-test, 2 sided
Other Pre-specified
Adverse Events/Complication Rates
composite measure
Time frame: 3, 6, 12, 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UT-DSAEK | Adverse Events/Complication Rates | Adverse Events at 3 months | 4 new adverse events reported |
| UT-DSAEK | Adverse Events/Complication Rates | Adverse Events at 24 months | 0 new adverse events reported |
| UT-DSAEK | Adverse Events/Complication Rates | Adverse Events at 6 months | 4 new adverse events reported |
| UT-DSAEK | Adverse Events/Complication Rates | Adverse Events at 12 months | 1 new adverse events reported |
| DMEK | Adverse Events/Complication Rates | Adverse Events at 3 months | 6 new adverse events reported |
| DMEK | Adverse Events/Complication Rates | Adverse Events at 12 months | 4 new adverse events reported |
| DMEK | Adverse Events/Complication Rates | Adverse Events at 6 months | 5 new adverse events reported |
| DMEK | Adverse Events/Complication Rates | Adverse Events at 24 months | 0 new adverse events reported |
Other Pre-specified
Graft Thickness
As measured by Optical coherence tomography (OCT) and Pachymetry
Time frame: 3, 6, 12, 24 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| UT-DSAEK | Graft Thickness | 3 months | 589.36 root mean square in micrometers |
| UT-DSAEK | Graft Thickness | 6 months | 592.24 root mean square in micrometers |
| UT-DSAEK | Graft Thickness | 12 months | 585.96 root mean square in micrometers |
| UT-DSAEK | Graft Thickness | 24 months | 593.67 root mean square in micrometers |
| DMEK | Graft Thickness | 24 months | 526.88 root mean square in micrometers |
| DMEK | Graft Thickness | 3 months | 516.5 root mean square in micrometers |
| DMEK | Graft Thickness | 12 months | 521.36 root mean square in micrometers |
| DMEK | Graft Thickness | 6 months | 519.67 root mean square in micrometers |
Other Pre-specified
Operative Times
Time frame: Baseline
Other Pre-specified
Refraction
Manifest refraction using phoropter
Time frame: 3, 6, 12, 24 months