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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| Stanford University | OTHER |
Not provided
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSAEK | Other | 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. |
|
| DMEK | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSAEK | Procedure |
| ||
| DMEK |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Refraction | Manifest refraction using phoropter | 3, 6, 12, 24 months |
| Graft Thickness | As measured by Optical coherence tomography (OCT) and Pachymetry |
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Winston Chamberlain, MD, PhD | Oregon Health and Science University | Principal Investigator |
| Jennifer Rose-Nussbaumer, MD | University of California, San Francisco | Principal Investigator |
| Charles Lin, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute, Stanford University | Palo Alto | California | 94303 | United States | ||
| F. I. Proctor Foundation, University of California, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24104929 | Background | Price FW Jr, Price MO. Evolution of endothelial keratoplasty. Cornea. 2013 Nov;32 Suppl 1:S28-32. doi: 10.1097/ICO.0b013e3182a0a307. | |
| 18520497 | Background | Chen ES, Terry MA, Shamie N, Hoar KL, Friend DJ. Descemet-stripping automated endothelial keratoplasty: six-month results in a prospective study of 100 eyes. Cornea. 2008 Jun;27(5):514-20. doi: 10.1097/ICO.0b013e3181611c50. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | One patient lost to followup | Posted | Mean | Standard Deviation | logMAR | 6 months | eyes | eyes |
|
24 months
Adverse events are reported by eye (N = 50), not by participant (N = 38).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glaucoma (nonsurgical) | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Rose-Nussbaumer | Kaiser Permanente / University of California, San Francisco | 650-299-2111 | Jennifer.Rose-Nussbaumer@kp.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 2, 2017 | Mar 26, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2017 | Mar 26, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D008775 | Methylprednisolone |
| D015242 | Ofloxacin |
| D014331 | Tropicamide |
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Endoserter | Device | 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 | Drug | Prednisolone is a corticosteroid used to alleviate swelling post-surgery. |
|
|
| Ofloxacin | Drug | Ofloxacin is an antibiotic used to treat bacterial infections of the eye. |
|
|
| Tropicamide | Drug | Tropicamide is a prescription drug used to dilate pupils during an eye exam. |
|
|
| Phenylephrine | Drug | Phenylephrine is a prescription drug used to dilate pupils during an eye exam. |
|
| Jones Tube | Device | 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 | 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). | 24 Months |
| Endothelial Cell Count | 3, 6, 12 months |
| Endothelial Cell Count | 24 months |
| 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. | 3, 6, 12 months |
| Corneal Higher-Order Aberrations | As measured by Pentacam | 24 months |
| Interface Haze | As measured by Pentacam densitometry | 3, 6, 12 months |
| Interface Haze | As measured by Pentacam densitometry | 24 months |
| 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. | Baseline, 12 months |
| Graft Failure/Graft Rejection | Baseline 12 months |
| Graft Failure/Graft Rejection | Baseline to 24 months |
| 3, 6, 12, 24 months |
| Operative Times | Baseline |
| Adverse Events/Complication Rates | composite measure | 3, 6, 12, 24 months |
| San Francisco |
| California |
| 94143 |
| United States |
| Casey Eye Institute, Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| 19182768 | Background | Ham L, Dapena I, van Luijk C, van der Wees J, Melles GR. Descemet membrane endothelial keratoplasty (DMEK) for Fuchs endothelial dystrophy: review of the first 50 consecutive cases. Eye (Lond). 2009 Oct;23(10):1990-8. doi: 10.1038/eye.2008.393. Epub 2009 Jan 30. |
| 22084160 | Background | Dirisamer M, van Dijk K, Dapena I, Ham L, Oganes O, Frank LE, Melles GR. Prevention and management of graft detachment in descemet membrane endothelial keratoplasty. Arch Ophthalmol. 2012 Mar;130(3):280-91. doi: 10.1001/archophthalmol.2011.343. Epub 2011 Nov 14. |
| 21598430 | Background | Kruse FE, Laaser K, Cursiefen C, Heindl LM, Schlotzer-Schrehardt U, Riss S, Bachmann BO. A stepwise approach to donor preparation and insertion increases safety and outcome of Descemet membrane endothelial keratoplasty. Cornea. 2011 May;30(5):580-7. doi: 10.1097/ico.0b013e3182000e2e. |
| 22197439 | Background | Rudolph M, Laaser K, Bachmann BO, Cursiefen C, Epstein D, Kruse FE. Corneal higher-order aberrations after Descemet's membrane endothelial keratoplasty. Ophthalmology. 2012 Mar;119(3):528-35. doi: 10.1016/j.ophtha.2011.08.034. Epub 2011 Dec 22. |
| 23466268 | Background | Busin M, Madi S, Santorum P, Scorcia V, Beltz J. Ultrathin descemet's stripping automated endothelial keratoplasty with the microkeratome double-pass technique: two-year outcomes. Ophthalmology. 2013 Jun;120(6):1186-94. doi: 10.1016/j.ophtha.2012.11.030. Epub 2013 Mar 1. |
| 21872938 | Background | Guerra FP, Anshu A, Price MO, Giebel AW, Price FW. Descemet's membrane endothelial keratoplasty: prospective study of 1-year visual outcomes, graft survival, and endothelial cell loss. Ophthalmology. 2011 Dec;118(12):2368-73. doi: 10.1016/j.ophtha.2011.06.002. Epub 2011 Aug 27. |
| 31046075 | Derived | Ang MJ, Chamberlain W, Lin CC, Pickel J, Austin A, Rose-Nussbaumer J. Effect of Unilateral Endothelial Keratoplasty on Vision-Related Quality-of-Life Outcomes in the Descemet Endothelial Thickness Comparison Trial (DETECT): A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2019 Jul 1;137(7):747-754. doi: 10.1001/jamaophthalmol.2019.0877. |
| 29945801 | Derived | Chamberlain W, Lin CC, Austin A, Schubach N, Clover J, McLeod SD, Porco TC, Lietman TM, Rose-Nussbaumer J. Descemet Endothelial Thickness Comparison Trial: A Randomized Trial Comparing Ultrathin Descemet Stripping Automated Endothelial Keratoplasty with Descemet Membrane Endothelial Keratoplasty. Ophthalmology. 2019 Jan;126(1):19-26. doi: 10.1016/j.ophtha.2018.05.019. Epub 2018 Jun 23. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| eyes |
|
| years |
| eyes |
|
|
| Sex: Female, Male | Count of Units | eyes | eyes |
|
|
| Race (NIH/OMB) | Count of Units | eyes | eyes |
|
|
| Region of Enrollment | Number | eyes | eyes |
|
|
| Diagnosis | Count of Units | eyes | eyes |
|
|
| Best Spectacle-Corrected Visual Acuity (logMAR) | ETDRS Best spectacle-corrected visual acuity in logarithm of the minimum angle of resolution (logMAR) units | Mean | Standard Deviation | logMAR | eyes |
|
|
| Surgery | Count of Units | eyes | eyes |
|
|
| Donor Age | Mean | Full Range | years | eyes |
|
|
| Donor Sex | Count of Units | eyes | eyes |
|
|
| Donor Death to Preservation Time | Mean | Standard Deviation | hours | eyes |
|
|
| Donor Death to Surgery Time | Mean | Standard Deviation | days | eyes |
|
|
| Donor Endothelial Cell Count (pre-processing) | Mean | Standard Deviation | cells/mm^2 | eyes |
|
|
| Donor Endothelial Cell Count (post-processing) | Mean | Standard Deviation | cells/mm^2 | eyes |
|
|
| Donor Central Graft Thickness (UT-DSAEK only) | Mean | Full Range | mm | eyes |
|
|
| Central Corneal Thickness | missing one value | Mean | Standard Deviation | microns | eyes |
|
|
| Spherical Equivalent | Mean | Standard Deviation | diopters | eyes |
|
|
| OG001 | 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. |
|
|
|
| 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). | Posted | Mean | Standard Deviation | logMAR | 3 and 12 months | eyes | eyes |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | LogMar | 24 Months | eyes | eyes |
|
|
|
| Secondary | Endothelial Cell Count | Posted | Mean | Standard Deviation | cells/mm^2 | 3, 6, 12 months | eyes | eyes |
|
|
|
|
| Secondary | Endothelial Cell Count | Posted | Mean | Standard Deviation | cells/mm^2 | 24 months | eyes | eyes |
|
|
|
| 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. | Posted | Mean | Standard Deviation | root mean square in micrometers | 3, 6, 12 months | eyes | eyes |
|
|
|
| Secondary | Corneal Higher-Order Aberrations | As measured by Pentacam | Posted | Mean | Standard Deviation | root mean square in micrometers | 24 months | eyes | eyes |
|
|
|
| Secondary | Interface Haze | As measured by Pentacam densitometry | Posted | Number | eyes | 3, 6, 12 months | eyes | eyes |
|
|
|
| Secondary | Interface Haze | As measured by Pentacam densitometry | Posted | Number | eyes | 24 months | eyes | 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. | 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. | Posted | Mean | Standard Deviation | Composite scores on a scale | Baseline, 12 months | eyes | eyes |
|
|
|
|
| Secondary | Graft Failure/Graft Rejection | Posted | Count of Units | eyes | Baseline 12 months | eyes | eyes |
|
|
|
| Secondary | Graft Failure/Graft Rejection | Posted | Count of Units | eyes | Baseline to 24 months | eyes | eyes |
|
|
|
| Other Pre-specified | Refraction | Manifest refraction using phoropter | Not Posted | 3, 6, 12, 24 months | Participants |
| Other Pre-specified | Graft Thickness | As measured by Optical coherence tomography (OCT) and Pachymetry | Posted | Mean | 95% Confidence Interval | root mean square in micrometers | 3, 6, 12, 24 months | eyes | eyes |
|
|
|
| Other Pre-specified | Operative Times | Not Posted | Baseline | Participants |
| Other Pre-specified | Adverse Events/Complication Rates | composite measure | Posted | Number | new adverse events reported | 3, 6, 12, 24 months | eyes | eyes |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 9 |
| 25 |
| EG001 | 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. | 0 | 25 | 0 | 25 | 7 | 25 |
| Glaucoma (surgical) | Eye disorders | Systematic Assessment |
|
| Graft displacement | Eye disorders | Systematic Assessment |
|
| Graft failure | Eye disorders | Systematic Assessment |
|
| Graft rejection | Eye disorders | Systematic Assessment |
|
| Infectious keratitis | Eye disorders | Systematic Assessment |
|
| Posterior synechiae | Eye disorders | Systematic Assessment |
|
| Re-bubble | Eye disorders | Systematic Assessment |
|
| Retinal tear | Eye disorders | Systematic Assessment |
|
| Visually significant central epithelial opacity | Eye disorders | Systematic Assessment |
|
| Intralocular lens repositioning | Eye disorders | Systematic Assessment |
|
| Epiretinal membrane and lamellar hole | Eye disorders | Systematic Assessment |
|
| Cystoid macular edema | Eye disorders | Systematic Assessment |
|
| Visual disturbance | Eye disorders | Systematic Assessment |
|
| Postoperative day 1 pupillary block | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
Comparison of 12 Month Visual Acuity Between Groups |
| Regression, Linear |
Multiple linear regression model with a covariate for baseline visual acuity |
| <0.001 |
| Coefficient |
| -1.4 |
| 2-Sided |
| 95 |
| -2.2 |
| -0.7 |
Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.4 lines better vision at 12 months. |
| Superiority |
| 12 Months |
|
| 0.17 |
| Coefficient |
| -150 |
| 2-Sided |
| 95 |
| -356 |
| 66 |
Comparing DMEK to UT-DSAEK at 6 months. |
| Superiority |
| t-test, 2 sided | 0.051 | Coefficient | -215 | 2-Sided | 95 | -430 | -0.4 | Comparing DMEK to UT-DSAEK at 12 months. | Superiority |
| 3 Months Anterior Cornea 6.0-mm |
|
| 3 Months Posterior Cornea 6.0-mm |
|
| 6 Months Anterior Cornea 4.0-mm |
|
| 6 Months Posterior Cornea 4.0-mm |
|
| 6 Months Anterior Cornea 6.0-mm |
|
| 6 Months Posterior Cornea 6.0-mm |
|
| 12 Months Anterior Cornea 4.0-mm |
|
| 12 Months Posterior Cornea 4.0-mm |
|
| 12 Months Anterior Cornea 6.0-mm |
|
| 12 Months Posterior Cornea 6.0-mm |
|
| 24 Months Anterior Cornea 6.0-mm |
|
| 24 Months Posterior Cornea 6.0-mm |
|
| Severe Interface Haze at 3 months |
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| Mild Interface Haze at 6 months |
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| oderate Interface Haze at 6 months |
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| Severe Interface Haze at 6 months |
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| Mild Interface Haze at 12 months |
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| oderate Interface Haze at 12 months |
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| Severe Interface Haze at 12 months |
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| Severe Interface Haze at 24 months |
|
|
| 12 Months |
|
|
| Eyes with No Graft Failure or Rejection |
|
| 12 months |
|
| 24 months |
|
| Adverse Events at 12 months |
|
| Adverse Events at 24 months |
|