Corneal Edema Secondary to Corneal Endothelial Dystrophy
Conditions
Keywords
Endothelial Dystrophy, Fuchs' Endothelial Corneal Dystrophy
Brief summary
The purpose of this study is to report the early clinical outcomes in patients undergoing Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) for corneal edema secondary to corneal endothelial cell dysfunction, and to correlate this clinical data with the latest generation of imaging modalities available for the anterior segment.
Detailed description
A concurrent study for retrospective as well as prospective cases of patients undergoing DSAEK procedures for indication of corneal endothelial cell dysfunction. For the retrospective study, all cases of DSAEK procedures performed at UT-Southwestern for corneal edema secondary to endothelial cell dysfunction will be considered. The clinical outcomes of these surgeries will be analyzed and correlated with the anterior segment imaging from each case. Statistical analysis will then be performed on the data collected. For the prospective arm of this trial, we propose to recruit up to 200 current patient cases of corneal edema second corneal endothelial cell dysfunction. These patients will undergo ocular imaging studies in addition to routine ocular exams performed before surgery and at the discretion of the investigational physician at 3 to 6-months and 6 to 9-months after surgical treatment. Various imaging modalities would include corneal topography, pentacam, anterior segment OCT, wavefront measurement and Tandem Scanning Confocal Microscopy (TSCM). The patients who have already had the DSAEK procedure done in the past will undergo ocular examination as well as various imaging studies at their post op follow up visits. All these modalities are routinely used as standard of care practice and are non-invasive. The data from the ocular examination and various imaging techniques will be pooled and analyzed at the end of the study in order to identify the factors that influence the visual outcome. We believe this will help us learn more about this interesting and innovative technique while at the same time help us improve the method further in order to obtain better results in future patients.
Interventions
PROCEDUREDSAEK
Endothelial Keratoplasty
DIAGNOSTIC_TESTAnterior Segment Optical Coherence Topography (OCT)
Non-contact, high resolution, cross sectional imaging of the anterior segment of the eye.
DIAGNOSTIC_TESTBest Spectacle Corrected Visual Acuity (BSCVA)
Visual acuity determined using a combination of detecting hand motion, counting fingers displayed and reading Snellen charts at specific distances.
Sponsors
University of Texas Southwestern Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 18 and up, where any age over 89 will be recorded as 'greater than 89', who have reviewed and understood the study consent form will be invited to participate in this study. * They will be recruited based on diagnosis of corneal edema secondary to endothelial cell dysfunction undergoing DSAEK either alone or in conjunction with phacoemulsification and intraocular lens implantation at the University of Texas Southwestern Medical Center at Dallas.
Exclusion criteria
* Patients younger than 18 years will not be considered for this trial. * The study will include all patients (no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Spectacle Corrected Visual Acuity (BSCVA) | 6-9 months Post-Operative | Best spectacle corrected visual acuity determined using detection of hand motion, counting of displayed fingers and accuracy of Snellen chart reading at specified distances. |
| Central Corneal Thickness | 6 to 9 Months Post-Operative | The central corneal thickness was determined manually by a single investigator from optical coherence tomography (OCT) measurements. A horizontal cross-sectional image with good central reflective light representing the anterior corneal vertex was used. |
| Peripheral Corneal Thickness | 6 to 9 Months Post-Operative | Peripheral corneal thickness was determined manually by a single investigator using the mean of 2 measurements taken by OCT 3.5 mm from the center of the cornea. |
Countries
United States
Participant flow
Recruitment details
Twenty one patients from UT Southwestern Medical Center's Ophthalmology clinic were included.
Participants by arm
| Arm | Count |
|---|---|
| DSAEK Group Patients who have corneal dystrophy and have elected to have DSAEK performed on his/her eye(s). | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Post-Operative 6-9 Months | Lost to Follow-up | 12 |
Baseline characteristics
| Characteristic | DSAEK Group |
|---|---|
| Age, Customized <=18 years | 0 Participants |
| Age, Customized >=65 years | 17 Participants |
| Age, Customized Between 18 and 65 years | 4 Participants |
| Best-Spectacle Corrected Visual Acuity (BSCVA) Finger Count only | 3 Participants |
| Best-Spectacle Corrected Visual Acuity (BSCVA) Hand Motion only | 1 Participants |
| Best-Spectacle Corrected Visual Acuity (BSCVA) Snellen fraction < or = 20/200 | 0 Participants |
| Best-Spectacle Corrected Visual Acuity (BSCVA) Snellen fraction < or = 20/20 and >20/50 | 12 Participants |
| Best-Spectacle Corrected Visual Acuity (BSCVA) Snellen fraction < or = 20/50 and >20/200 | 5 Participants |
| Sex/Gender, Customized Female | 9 Participants |
| Sex/Gender, Customized Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Best Spectacle Corrected Visual Acuity (BSCVA)
Best spectacle corrected visual acuity determined using detection of hand motion, counting of displayed fingers and accuracy of Snellen chart reading at specified distances.
Time frame: 6-9 months Post-Operative
Population: The number of participant, for analysis, were determined per protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSAEK Group | Best Spectacle Corrected Visual Acuity (BSCVA) | finger count only | 3 Participants |
| DSAEK Group | Best Spectacle Corrected Visual Acuity (BSCVA) | Snellen fraction < or = 20/200 | 7 Participants |
| DSAEK Group | Best Spectacle Corrected Visual Acuity (BSCVA) | Snellen fraction < or = 20/50 and >20/200 | 9 Participants |
| DSAEK Group | Best Spectacle Corrected Visual Acuity (BSCVA) | Snellen fraction < or = 20/20 and >20/50 | 1 Participants |
| DSAEK Group | Best Spectacle Corrected Visual Acuity (BSCVA) | hand motion only | 1 Participants |
Primary
Central Corneal Thickness
The central corneal thickness was determined manually by a single investigator from optical coherence tomography (OCT) measurements. A horizontal cross-sectional image with good central reflective light representing the anterior corneal vertex was used.
Time frame: 6 to 9 Months Post-Operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DSAEK Group | Central Corneal Thickness | 686.6 micrometer | Standard Deviation 72 |
Primary
Peripheral Corneal Thickness
Peripheral corneal thickness was determined manually by a single investigator using the mean of 2 measurements taken by OCT 3.5 mm from the center of the cornea.
Time frame: 6 to 9 Months Post-Operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DSAEK Group | Peripheral Corneal Thickness | 710 micrometer | Standard Deviation 105 |