Epithelium, Corneal
Conditions
Keywords
Removal of corneal epithelium followed by excimer laser treatment during prk
Brief summary
The purpose of this study is a prospective,double-blinded, randomized trial to compare the rate of healing following PRK after the use of two commercially available 4th generation fluoroquinolones, moxifloxacin and gatifloxacin.
Interventions
DRUGMoxifloxacin
1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
DRUGGatifloxacin
1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
Sponsors
Walter Reed Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Manifest refraction spherical equivalent (MSE) of up to -6.00 diopters (D) at the spectacle plane with refractive cylinder up to 3.00D.
Exclusion criteria
* Concurrent topical or systemic medications that may impair healing including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin. * Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course. * Anterior basement membrane dystrophy. * History of recurrent epithelial erosion. * Significant dry eye (symptomatic sith Schirmer \<5mm at 5 minutes) * Other corneal epithelial disorder or healing abnormality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Epithelial Healing Time | 3 to 4 days after surgery | patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Moxifloxacin/Gatifloxacin Treatment Both eyes were treated. Each participant was randomly assigned to either:
Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye
Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye
Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Moxifloxacin/Gatifloxacin Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Age Continuous | 33.7 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Corneal Epithelial Healing Time
patients' eyes will be observed daily after surgery until the corneal epithelium has completely healed (usually 3 to 4 days)
Time frame: 3 to 4 days after surgery
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Moxifloxacin | Corneal Epithelial Healing Time | 4 days to complete epithelial healing | Full Range 1 |
| Gatifloxacin | Corneal Epithelial Healing Time | 4 days to complete epithelial healing | Full Range 1.4 |