Trial · NCT02373137
Descemet Endothelial Thickness Comparison Trial
NCT02373137, Phase 4, Unknown, Oregon Health and Science University; results first posted 2019-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Descemet Endothelial Thickness Comparison Trial. Trials, record NCT02373137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02373137
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Descemet Endothelial Thickness Comparison Trial
- NCT number
- NCT02373137
- Status
- Unknown
- Phases
- Phase 4
- Enrollment
- 38 participants, actual
- Lead sponsor
- Oregon Health and Science University
- Conditions
- Keratoplasty, Grafting, Corneal, Transplantation, Corneal, Transplantation, Cornea, Keratoplasty, Lamellar
- Interventions
- DSAEK, DMEK, Endoserter, Prednisolone, Ofloxacin, Tropicamide, Phenylephrine, Jones Tube
- First posted
- 2015-02-26
- Last updated
- 2020-11-25
- Results first posted
- 2019-07-02
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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). |
| Secondary | Best Spectacle-Corrected Visual Acuity | 24 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 | Endothelial Cell Count | 3, 6, 12 months | |
| Secondary | Endothelial Cell Count | 24 months | |
| Secondary | 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. |
| Secondary | Corneal Higher-Order Aberrations | 24 months | As measured by Pentacam |
| Secondary | Interface Haze | 3, 6, 12 months | As measured by Pentacam densitometry |
| Secondary | Interface Haze | 24 months | As measured by Pentacam densitometry |
| Secondary | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Spectacle-Corrected Visual Acuity | 6 months | One patient lost to followup | logMAR | MEAN |
| SECONDARY | Best Spectacle-Corrected Visual Acuity | 3 and 12 months | logMAR | MEAN | |
| SECONDARY | Best Spectacle-Corrected Visual Acuity | 24 Months | LogMar | MEAN | |
| SECONDARY | Endothelial Cell Count | 3, 6, 12 months | cells/mm^2 | MEAN | |
| SECONDARY | Endothelial Cell Count | 24 months | cells/mm^2 | MEAN | |
| SECONDARY | Corneal Higher-Order Aberrations | 3, 6, 12 months | root mean square in micrometers | MEAN | |
| SECONDARY | Corneal Higher-Order Aberrations | 24 months | root mean square in micrometers | MEAN | |
| SECONDARY | Interface Haze | 3, 6, 12 months | eyes | NUMBER | |
| SECONDARY | Interface Haze | 24 months | eyes | NUMBER | |
| SECONDARY | National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ) | Baseline, 12 months | 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. | Composite scores on a scale | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Spectacle-Corrected Visual Acuity | UT-DSAEK | 0.22 | Standard Deviation 0.16 | logMAR | |
| Best Spectacle-Corrected Visual Acuity | DMEK | 0.05 | Standard Deviation 0.11 | logMAR | |
| Best Spectacle-Corrected Visual Acuity | UT-DSAEK | 3 Months | 0.24 | Standard Deviation 0.21 | logMAR |
| Best Spectacle-Corrected Visual Acuity | DMEK | 3 Months | 0.11 | Standard Deviation 0.13 | logMAR |
| Best Spectacle-Corrected Visual Acuity | UT-DSAEK | 12 Months | 0.16 | Standard Deviation 0.18 | logMAR |
| Best Spectacle-Corrected Visual Acuity | DMEK | 12 Months | 0.04 | Standard Deviation 0.12 | logMAR |
| Best Spectacle-Corrected Visual Acuity | UT-DSAEK | 0.15 | Standard Deviation 0.15 | LogMar | |
| Best Spectacle-Corrected Visual Acuity | DMEK | 0.09 | Standard Deviation 0.16 | LogMar | |
| Endothelial Cell Count | UT-DSAEK | 3 Months | 2114 | Standard Deviation 357 | cells/mm^2 |
| Endothelial Cell Count | DMEK | 3 Months | 2037 | Standard Deviation 495 | cells/mm^2 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | UT-DSAEK | 19 | 25 |
| Overall Study | STARTED | DMEK | 19 | 25 |
| Overall Study | 3-Month Follow-Up | UT-DSAEK | 19 | 25 |
| Overall Study | 3-Month Follow-Up | DMEK | 19 | 25 |
| Overall Study | 6-Month Follow-Up | UT-DSAEK | 19 | 25 |
| Overall Study | 6-Month Follow-Up | DMEK | 18 | 24 |
| Overall Study | 12-Month Follow-Up | UT-DSAEK | 19 | 25 |
| Overall Study | 12-Month Follow-Up | DMEK | 19 | 25 |
| Overall Study | COMPLETED | UT-DSAEK | 18 | 24 |
| Overall Study | COMPLETED | DMEK | 18 | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Glaucoma (nonsurgical) | Eye disorders | UT-DSAEK | 2 | 25 | |
| other | Glaucoma (nonsurgical) | Eye disorders | DMEK | 2 | 25 | |
| other | Glaucoma (surgical) | Eye disorders | UT-DSAEK | 1 | 25 | |
| other | Glaucoma (surgical) | Eye disorders | DMEK | 1 | 25 | |
| other | Graft displacement | Eye disorders | UT-DSAEK | 1 | 25 | |
| other | Graft displacement | Eye disorders | DMEK | 0 | 25 | |
| other | Graft failure | Eye disorders | UT-DSAEK | 1 | 25 | |
| other | Graft failure | Eye disorders | DMEK | 1 | 25 | |
| other | Graft rejection | Eye disorders | UT-DSAEK | 0 | 25 | |
| other | Graft rejection | Eye disorders | DMEK | 0 | 25 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | UT-DSAEK | 0 | 25 |
| Total, all-cause mortality | DMEK | 0 | 25 |
| Total, other adverse events | UT-DSAEK | 9 | 25 |
| Total, other adverse events | DMEK | 7 | 25 |
| Total, serious adverse events | UT-DSAEK | 0 | 25 |
| Total, serious adverse events | DMEK | 0 | 25 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| UT-DSAEK vs DMEK: deaths from any cause | Trial comparisons |
| UT-DSAEK vs DMEK: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02373137
GET https://conductscience.org/api/trials/v1/NCT02373137/results?page=2