Trial Outcomes & Findings for Descemet Endothelial Thickness Comparison Trial (NCT NCT02373137)

Last Updated: 2020-11-25

Results Overview

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).

Recruitment status

UNKNOWN

Study phase

PHASE4

Target enrollment

38 participants

Primary outcome timeframe

6 months

Results posted on

2020-11-25

Participant Flow

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	19 25	19 25
Overall Study 3-Month Follow-Up	19 25	19 25
Overall Study 6-Month Follow-Up	19 25	18 24
Overall Study 12-Month Follow-Up	19 25	19 25
Overall Study COMPLETED	18 24	18 23
Overall Study NOT COMPLETED	1 1	1 2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

missing one value

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UT-DSAEK n=25 eyes 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.	DMEK n=25 eyes 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.	Total n=50 eyes Total of all reporting groups
Age, Continuous	68 years n=25 eyes	68 years n=25 eyes	68 years n=50 eyes
Sex: Female, Male Female	16 eyes n=25 eyes	13 eyes n=25 eyes	29 eyes n=50 eyes
Sex: Female, Male Male	9 eyes n=25 eyes	12 eyes n=25 eyes	21 eyes n=50 eyes
Race (NIH/OMB) American Indian or Alaska Native	0 eyes n=25 eyes	0 eyes n=25 eyes	0 eyes n=50 eyes
Race (NIH/OMB) Asian	1 eyes n=25 eyes	1 eyes n=25 eyes	2 eyes n=50 eyes
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 eyes n=25 eyes	0 eyes n=25 eyes	0 eyes n=50 eyes
Race (NIH/OMB) Black or African American	0 eyes n=25 eyes	0 eyes n=25 eyes	0 eyes n=50 eyes
Race (NIH/OMB) White	24 eyes n=25 eyes	24 eyes n=25 eyes	48 eyes n=50 eyes
Race (NIH/OMB) More than one race	0 eyes n=25 eyes	0 eyes n=25 eyes	0 eyes n=50 eyes
Race (NIH/OMB) Unknown or Not Reported	0 eyes n=25 eyes	0 eyes n=25 eyes	0 eyes n=50 eyes
Region of Enrollment United States	25 eyes n=25 eyes	25 eyes n=25 eyes	50 eyes n=50 eyes
Diagnosis Fuch's Dystrophy	24 eyes n=25 eyes	24 eyes n=25 eyes	48 eyes n=50 eyes
Diagnosis Pseudophakic Bullous Keratopathy	1 eyes n=25 eyes	1 eyes n=25 eyes	2 eyes n=50 eyes
Best Spectacle-Corrected Visual Acuity (logMAR)	0.27 logMAR STANDARD_DEVIATION 0.21 • n=25 eyes	0.34 logMAR STANDARD_DEVIATION 0.29 • n=25 eyes	0.30 logMAR STANDARD_DEVIATION 0.25 • n=50 eyes
Surgery Pseudophakic Endothelial Keratoplasty	8 eyes n=25 eyes	7 eyes n=25 eyes	15 eyes n=50 eyes
Surgery Triple Endothelial Keratoplasty	17 eyes n=25 eyes	18 eyes n=25 eyes	35 eyes n=50 eyes
Donor Age	64 years n=25 eyes	62 years n=25 eyes	63 years n=50 eyes
Donor Sex Female	8 eyes n=25 eyes	5 eyes n=25 eyes	13 eyes n=50 eyes
Donor Sex Male	17 eyes n=25 eyes	20 eyes n=25 eyes	37 eyes n=50 eyes
Donor Death to Preservation Time	9 hours STANDARD_DEVIATION 4 • n=25 eyes	9 hours STANDARD_DEVIATION 3 • n=25 eyes	9 hours STANDARD_DEVIATION 4 • n=50 eyes
Donor Death to Surgery Time	6 days STANDARD_DEVIATION 1 • n=25 eyes	6 days STANDARD_DEVIATION 1 • n=25 eyes	6 days STANDARD_DEVIATION 1 • n=50 eyes
Donor Endothelial Cell Count (pre-processing)	2792 cells/mm^2 STANDARD_DEVIATION 210 • n=25 eyes	2797 cells/mm^2 STANDARD_DEVIATION 222 • n=25 eyes	2795 cells/mm^2 STANDARD_DEVIATION 214 • n=50 eyes
Donor Endothelial Cell Count (post-processing)	2796 cells/mm^2 STANDARD_DEVIATION 238 • n=25 eyes	2771 cells/mm^2 STANDARD_DEVIATION 150 • n=25 eyes	2783 cells/mm^2 STANDARD_DEVIATION 197 • n=50 eyes
Donor Central Graft Thickness (UT-DSAEK only)	73 mm n=25 eyes	NA mm n=25 eyes	73 mm n=50 eyes
Central Corneal Thickness	610 microns STANDARD_DEVIATION 44 • n=24 eyes • missing one value	608 microns STANDARD_DEVIATION 52 • n=25 eyes • missing one value	609 microns STANDARD_DEVIATION 48 • n=49 eyes • missing one value
Spherical Equivalent	-0.4 diopters STANDARD_DEVIATION 1.9 • n=25 eyes	-0.8 diopters STANDARD_DEVIATION 2.2 • n=25 eyes	-0.6 diopters STANDARD_DEVIATION 2.0 • n=50 eyes

PRIMARY outcome

Timeframe: 6 months

Population: One patient lost to followup

Outcome measures

Outcome measures
Measure	UT-DSAEK n=25 eyes 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.	DMEK n=24 eyes 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.
Best Spectacle-Corrected Visual Acuity	0.22 logMAR Standard Deviation 0.16	0.05 logMAR Standard Deviation 0.11

SECONDARY outcome

Timeframe: 3 and 12 months

Outcome measures

Outcome measures
Measure	UT-DSAEK n=25 eyes 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.	DMEK n=25 eyes 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.
Best Spectacle-Corrected Visual Acuity 3 Months	0.24 logMAR Standard Deviation 0.21	0.11 logMAR Standard Deviation 0.13
Best Spectacle-Corrected Visual Acuity 12 Months	0.16 logMAR Standard Deviation 0.18	0.04 logMAR Standard Deviation 0.12

SECONDARY outcome

Timeframe: 24 Months

Outcome measures

Outcome measures
Measure	UT-DSAEK n=25 eyes 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.	DMEK n=25 eyes 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.
Best Spectacle-Corrected Visual Acuity	0.15 LogMar Standard Deviation 0.15	0.09 LogMar Standard Deviation 0.16

SECONDARY outcome

Timeframe: 3, 6, 12 months

Outcome measures

Outcome measures
Measure	UT-DSAEK n=25 eyes 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.	DMEK n=25 eyes 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.
Endothelial Cell Count 3 Months	2114 cells/mm^2 Standard Deviation 357	2037 cells/mm^2 Standard Deviation 495
Endothelial Cell Count 6 Months	2113 cells/mm^2 Standard Deviation 301	1963 cells/mm^2 Standard Deviation 425
Endothelial Cell Count 12 Months	2070 cells/mm^2 Standard Deviation 292	1855 cells/mm^2 Standard Deviation 448

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Outcome measures
Measure	UT-DSAEK n=25 eyes 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.	DMEK n=25 eyes 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.
Endothelial Cell Count	1626 cells/mm^2 Standard Deviation 362	1400 cells/mm^2 Standard Deviation 498

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	UT-DSAEK n=19 Participants 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.	DMEK n=25 eyes 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.
Corneal Higher-Order Aberrations 3 Months Anterior Cornea 4.0-mm	0.274 root mean square in micrometers Standard Deviation 0.223	0.288 root mean square in micrometers Standard Deviation 0.104
Corneal Higher-Order Aberrations 3 Months Posterior Cornea 4.0-mm	0.217 root mean square in micrometers Standard Deviation 0.110	0.116 root mean square in micrometers Standard Deviation 0.056
Corneal Higher-Order Aberrations 3 Months Anterior Cornea 6.0-mm	0.897 root mean square in micrometers Standard Deviation 0.800	0.829 root mean square in micrometers Standard Deviation 0.367
Corneal Higher-Order Aberrations 3 Months Posterior Cornea 6.0-mm	0.621 root mean square in micrometers Standard Deviation 0.308	0.346 root mean square in micrometers Standard Deviation 0.153
Corneal Higher-Order Aberrations 6 Months Anterior Cornea 4.0-mm	0.230 root mean square in micrometers Standard Deviation 0.110	0.243 root mean square in micrometers Standard Deviation 0.100
Corneal Higher-Order Aberrations 6 Months Posterior Cornea 4.0-mm	0.179 root mean square in micrometers Standard Deviation 0.067	0.095 root mean square in micrometers Standard Deviation 0.031
Corneal Higher-Order Aberrations 6 Months Anterior Cornea 6.0-mm	0.739 root mean square in micrometers Standard Deviation 0.371	0.724 root mean square in micrometers Standard Deviation 0.337
Corneal Higher-Order Aberrations 6 Months Posterior Cornea 6.0-mm	0.505 root mean square in micrometers Standard Deviation 0.217	0.288 root mean square in micrometers Standard Deviation 0.089
Corneal Higher-Order Aberrations 12 Months Anterior Cornea 4.0-mm	0.228 root mean square in micrometers Standard Deviation 0.108	0.241 root mean square in micrometers Standard Deviation 0.100
Corneal Higher-Order Aberrations 12 Months Posterior Cornea 4.0-mm	0.159 root mean square in micrometers Standard Deviation 0.068	0.098 root mean square in micrometers Standard Deviation 0.028
Corneal Higher-Order Aberrations 12 Months Anterior Cornea 6.0-mm	0.725 root mean square in micrometers Standard Deviation 0.344	0.723 root mean square in micrometers Standard Deviation 0.328
Corneal Higher-Order Aberrations 12 Months Posterior Cornea 6.0-mm	0.459 root mean square in micrometers Standard Deviation 0.206	0.284 root mean square in micrometers Standard Deviation 0.073

SECONDARY outcome

Timeframe: 24 months

As measured by Pentacam

Outcome measures

Outcome measures
Measure	UT-DSAEK n=25 eyes 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.	DMEK n=25 eyes 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.
Corneal Higher-Order Aberrations 24 Months Anterior Cornea 4.0-mm	0.215 root mean square in micrometers Standard Deviation 0.136	0.211 root mean square in micrometers Standard Deviation 0.008
Corneal Higher-Order Aberrations 24 Months Posterior Cornea 4.0-mm	0.155 root mean square in micrometers Standard Deviation 0.075	0.086 root mean square in micrometers Standard Deviation 0.029
Corneal Higher-Order Aberrations 24 Months Anterior Cornea 6.0-mm	0.707 root mean square in micrometers Standard Deviation 0.389	0.679 root mean square in micrometers Standard Deviation 0.314
Corneal Higher-Order Aberrations 24 Months Posterior Cornea 6.0-mm	0.450 root mean square in micrometers Standard Deviation 0.216	0.260 root mean square in micrometers Standard Deviation 0.008

SECONDARY outcome

Timeframe: 3, 6, 12 months

As measured by Pentacam densitometry

Outcome measures

Outcome measures
Measure	UT-DSAEK n=25 eyes 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.	DMEK n=25 eyes 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.
Interface Haze Mild Interface Haze at 3 months	2 eyes	1 eyes
Interface Haze Moderate Interface Haze at 3 months	0 eyes	0 eyes
Interface Haze Severe Interface Haze at 3 months	0 eyes	0 eyes
Interface Haze Mild Interface Haze at 6 months	2 eyes	1 eyes
Interface Haze oderate Interface Haze at 6 months	1 eyes	0 eyes
Interface Haze Severe Interface Haze at 6 months	0 eyes	0 eyes
Interface Haze Mild Interface Haze at 12 months	0 eyes	0 eyes
Interface Haze oderate Interface Haze at 12 months	0 eyes	0 eyes
Interface Haze Severe Interface Haze at 12 months	0 eyes	0 eyes

SECONDARY outcome

Timeframe: 24 months

As measured by Pentacam densitometry

Outcome measures

Outcome measures
Measure	UT-DSAEK n=25 eyes 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.	DMEK n=25 eyes 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.
Interface Haze Moderate Interface Haze at 24 months	1 eyes	0 eyes
Interface Haze Severe Interface Haze at 24 months	0 eyes	0 eyes
Interface Haze Mild Interface Haze at 24 months	0 eyes	0 eyes

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	UT-DSAEK n=19 eyes 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.	DMEK n=19 eyes 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.
National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ) Baseline	72.5 Composite scores on a scale Standard Deviation 13.4	72.3 Composite scores on a scale Standard Deviation 15.2
National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ) 12 Months	85.9 Composite scores on a scale Standard Deviation 9.1	87.3 Composite scores on a scale Standard Deviation 9.5

SECONDARY outcome

Timeframe: Baseline 12 months

Outcome measures

Outcome measures
Measure	UT-DSAEK n=25 eyes 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.	DMEK n=25 eyes 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.
Graft Failure/Graft Rejection Graft Rejection	0 eyes	0 eyes
Graft Failure/Graft Rejection Graft Failure	1 eyes	1 eyes

SECONDARY outcome

Timeframe: Baseline to 24 months

Outcome measures

Outcome measures
Measure	UT-DSAEK n=25 eyes 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.	DMEK n=25 eyes 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.
Graft Failure/Graft Rejection Graft Rejection	0 eyes	0 eyes
Graft Failure/Graft Rejection Graft Failure	1 eyes	1 eyes
Graft Failure/Graft Rejection Eyes with No Graft Failure or Rejection	24 eyes	24 eyes

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 12, 24 months

Manifest refraction using phoropter

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 12, 24 months

As measured by Optical coherence tomography (OCT) and Pachymetry

Outcome measures

Outcome measures
Measure	UT-DSAEK n=25 eyes 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.	DMEK n=25 eyes 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.
Graft Thickness 3 months	589.36 root mean square in micrometers Interval 568.4 to 614.5	516.5 root mean square in micrometers Interval 499.4 to 533.35
Graft Thickness 6 months	592.24 root mean square in micrometers Interval 573.92 to 612.84	519.67 root mean square in micrometers Interval 504.75 to 533.88
Graft Thickness 12 months	585.96 root mean square in micrometers Interval 569.32 to 603.12	521.36 root mean square in micrometers Interval 506.28 to 536.32
Graft Thickness 24 months	593.67 root mean square in micrometers Interval 577.08 to 612.21	526.88 root mean square in micrometers Interval 512.2 to 541.28

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3, 6, 12, 24 months

composite measure

Outcome measures

Outcome measures
Measure	UT-DSAEK n=25 eyes 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.	DMEK n=25 eyes 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.
Adverse Events/Complication Rates Adverse Events at 3 months	4 new adverse events reported	6 new adverse events reported
Adverse Events/Complication Rates Adverse Events at 6 months	4 new adverse events reported	5 new adverse events reported
Adverse Events/Complication Rates Adverse Events at 12 months	1 new adverse events reported	4 new adverse events reported
Adverse Events/Complication Rates Adverse Events at 24 months	0 new adverse events reported	0 new adverse events reported

Adverse Events

UT-DSAEK

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

DMEK

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Jennifer Rose-Nussbaumer

Kaiser Permanente / University of California, San Francisco

Phone: 650-299-2111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	UT-DSAEK n=25 participants at risk 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.	DMEK n=25 participants at risk 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.
Eye disorders Glaucoma (nonsurgical)	8.0% 2/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	8.0% 2/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).
Eye disorders Glaucoma (surgical)	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).
Eye disorders Graft displacement	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	0.00% 0/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).
Eye disorders Graft failure	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).
Eye disorders Graft rejection	0.00% 0/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	0.00% 0/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).
Eye disorders Infectious keratitis	0.00% 0/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	0.00% 0/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).
Eye disorders Posterior synechiae	0.00% 0/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).
Eye disorders Re-bubble	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	24.0% 6/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).
Eye disorders Retinal tear	0.00% 0/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).
Eye disorders Visually significant central epithelial opacity	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	0.00% 0/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).
Eye disorders Intralocular lens repositioning	0.00% 0/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).
Eye disorders Epiretinal membrane and lamellar hole	0.00% 0/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).
Eye disorders Cystoid macular edema	0.00% 0/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).
Eye disorders Visual disturbance	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).
Eye disorders Postoperative day 1 pupillary block	4.0% 1/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).	0.00% 0/25 • 24 months Adverse events are reported by eye (N = 50), not by participant (N = 38).