Bullous Keratopathy, Fuchs' Dystrophy
Conditions
Keywords
DMEK, Rejection, Corticosteroid
Brief summary
The purpose of this study is to compare two different commonly used steroid dosing regimens after Descemet's membrane endothelial keratoplasty (DMEK) transplant surgery. The investigators hope to determine if one is more effective at preventing rejection or if both are equally effective.
Detailed description
Graft rejection is one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used after transplant surgery. The steroid eye drop dosing regimen varies from surgeon to surgeon, because no studies have been done to determine the optimum dosing regimen.
Interventions
DRUGPrednisolone acetate
Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
DRUGFluorometholone
Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.
Sponsors
Price Vision Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The following are requirements for inclusion in the study: * Male or female patient, at least 18 years of age, who is a candidate for DMEK due to corneal endothelial dysfunction or who has undergone DMEK within the last 7 weeks * Patient is able and willing to administer eye drops. * Patient is able to comprehend and has signed the Informed Consent form. * Patient is likely to complete the entire one-year course of the study. * Patient has best corrected visual acuity (BCVA) of at least 20/200 in the fellow eye. * Corneal neovascularization will not be judged as an
Exclusion criteria
for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Eyes With Immunologic Graft Rejection Episodes | Within 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With Intraocular Pressure (IOP) Elevation | one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK | Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading. |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluorometholone 0.1% Solution Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.
Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study. | 161 |
| Prednisolone Acetate 1% Solution Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study. | 164 |
| Total | 325 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 10 |
| Overall Study | Lost to Follow-up | 12 | 10 |
| Overall Study | Protocol Violation | 1 | 2 |
Baseline characteristics
| Characteristic | Fluorometholone 0.1% Solution | Prednisolone Acetate 1% Solution | Total |
|---|---|---|---|
| Age, Continuous | 69 years | 67 years | 68 years |
| Sex: Female, Male Female | 107 Participants | 105 Participants | 212 Participants |
| Sex: Female, Male Male | 54 Participants | 59 Participants | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 130 | 13 / 134 |
| serious Total, serious adverse events | 0 / 130 | 0 / 134 |
Outcome results
Primary
Number of Eyes With Immunologic Graft Rejection Episodes
Time frame: Within 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluorometholone 0.1% Solution | Number of Eyes With Immunologic Graft Rejection Episodes | 2 eyes |
| Prednisolone Acetate 1% Solution | Number of Eyes With Immunologic Graft Rejection Episodes | 0 eyes |
p-value: 0.17Log Rank
Secondary
Number of Eyes With Intraocular Pressure (IOP) Elevation
Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading.
Time frame: one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluorometholone 0.1% Solution | Number of Eyes With Intraocular Pressure (IOP) Elevation | 9 eyes |
| Prednisolone Acetate 1% Solution | Number of Eyes With Intraocular Pressure (IOP) Elevation | 32 eyes |
p-value: 0.0005Log Rank