Intraocular Pressure, Corneal Opacity
Conditions
Keywords
Photorefractive keratectomy
Brief summary
Corneal haze, in which the cornea becomes cloudy, is a well-known and a potentially vision-threatening postoperative complication of photorefractive keratectomy (PRK). Topical ophthalmic corticosteroids are routinely prescribed by most surgeons postoperatively to help prevent this complication. Goals of topical steroids use after PRK include effective modulation of the healing response to prevent corneal haze while at the same time minimizing side effects, such as intraocular pressure elevation or cataract formation. Loteprednol etabonate is a corticosteroid that exerts its therapeutic effects and is then quickly changed into inactive metabolites. This relatively fast metabolism of loteprednol gives it a lower side effect profile than other steroids, including a smaller effect on intraocular pressure. In the ophthalmic literature, there is currently no consensus on a standard regimen or which type of corticosteroid should be used after PRK. Investigators are conducting a prospective, randomized trial to compare the incidence of intraocular pressure rise and visually significant postoperative corneal haze after PRK with the use of loteprednol 0.5% gel compared to the use of earlier generation steroids, prednisolone acetate 1% suspension and fluorometholone 0.1% suspension.
Interventions
DRUGLoteprednol Etabonate 0.5% Oph Gel
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Examiners are masked to the treatment arm when obtaining measurements of intraocular pressure (IOP) and grading corneal haze.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All subjects who are deemed suitable candidates for PRK after routine refractive surgery screening will be considered eligible for participation in this study. * Subjects must be at least 21 years of age and not pregnant or nursing (due to fluctuations in visual parameters during pregnancy).
Exclusion criteria
* Selection will be consistent with the current standard of care for PRK. Any patient that is not a suitable candidate for PRK will not be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure (IOP) From Baseline Through Month 3 | Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op | Intraocular pressure will be measured by applanation tonometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With Corneal Haze | 12 months | As determined by slit lamp examination |
| Uncorrected Visual Acuity | 3 months | Best uncorrected visual acuity will be measured at 3 months |
| Best Corrected Visual Acuity at 3 Months | 3 months | Best uncorrected visual acuity will be measured at 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Loteprednol Etabonate 0.5% Oph Gel Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response.
Loteprednol Etabonate 0.5% Oph Gel | 57 |
| Prednisolone Acetate 1% Oph Susp Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response.
Prednisolone Acetate 1% Oph Susp | 74 |
| Total | 131 |
Baseline characteristics
| Characteristic | Loteprednol Etabonate 0.5% Oph Gel | Prednisolone Acetate 1% Oph Susp | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 74 Participants | 131 Participants |
| Age, Continuous | 34.6 years STANDARD_DEVIATION 8.8 | 35.3 years STANDARD_DEVIATION 6.2 | 35.0 years STANDARD_DEVIATION 7.3 |
| Intraocular Pressure | 14.38 mmHg STANDARD_DEVIATION 2.11 | 14.30 mmHg STANDARD_DEVIATION 2.13 | 14.34 mmHg STANDARD_DEVIATION 2.12 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 57 Participants | 74 Participants | 131 Participants |
| Sex: Female, Male Female | 24 Participants | 36 Participants | 60 Participants |
| Sex: Female, Male Male | 33 Participants | 38 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 74 |
| other Total, other adverse events | 3 / 57 | 7 / 74 |
| serious Total, serious adverse events | 0 / 57 | 0 / 74 |
Outcome results
Primary
Change in Intraocular Pressure (IOP) From Baseline Through Month 3
Intraocular pressure will be measured by applanation tonometry
Time frame: Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loteprednol Etabonate 0.5% Oph Gel | Change in Intraocular Pressure (IOP) From Baseline Through Month 3 | IOP 1 week postop | 13.67 mmHg | Standard Deviation 2.34 |
| Loteprednol Etabonate 0.5% Oph Gel | Change in Intraocular Pressure (IOP) From Baseline Through Month 3 | IOP 2 months postop | 13.36 mmHg | Standard Deviation 2.53 |
| Loteprednol Etabonate 0.5% Oph Gel | Change in Intraocular Pressure (IOP) From Baseline Through Month 3 | IOP 1 month postop | 14.15 mmHg | Standard Deviation 2.88 |
| Loteprednol Etabonate 0.5% Oph Gel | Change in Intraocular Pressure (IOP) From Baseline Through Month 3 | IOP 3 months postop | 13.15 mmHg | Standard Deviation 2.43 |
| Loteprednol Etabonate 0.5% Oph Gel | Change in Intraocular Pressure (IOP) From Baseline Through Month 3 | Baseline intraocular pressure (IOP) | 14.38 mmHg | Standard Deviation 2.11 |
| Prednisolone Acetate 1% Oph Susp | Change in Intraocular Pressure (IOP) From Baseline Through Month 3 | IOP 3 months postop | 12.22 mmHg | Standard Deviation 2.38 |
| Prednisolone Acetate 1% Oph Susp | Change in Intraocular Pressure (IOP) From Baseline Through Month 3 | Baseline intraocular pressure (IOP) | 14.30 mmHg | Standard Deviation 2.13 |
| Prednisolone Acetate 1% Oph Susp | Change in Intraocular Pressure (IOP) From Baseline Through Month 3 | IOP 1 week postop | 13.28 mmHg | Standard Deviation 3.37 |
| Prednisolone Acetate 1% Oph Susp | Change in Intraocular Pressure (IOP) From Baseline Through Month 3 | IOP 1 month postop | 14.60 mmHg | Standard Deviation 4.2 |
| Prednisolone Acetate 1% Oph Susp | Change in Intraocular Pressure (IOP) From Baseline Through Month 3 | IOP 2 months postop | 13.16 mmHg | Standard Deviation 2.8 |
Secondary
Best Corrected Visual Acuity at 3 Months
Best uncorrected visual acuity will be measured at 3 months
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loteprednol Etabonate 0.5% Oph Gel | Best Corrected Visual Acuity at 3 Months | -0.120 logMAR | Standard Deviation 0.059 |
| Prednisolone Acetate 1% Oph Susp | Best Corrected Visual Acuity at 3 Months | -0.114 logMAR | Standard Deviation 0.03 |
Secondary
Number of Eyes With Corneal Haze
As determined by slit lamp examination
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Loteprednol Etabonate 0.5% Oph Gel | Number of Eyes With Corneal Haze | 3 Eyes |
| Prednisolone Acetate 1% Oph Susp | Number of Eyes With Corneal Haze | 7 Eyes |
Secondary
Uncorrected Visual Acuity
Best uncorrected visual acuity will be measured at 3 months
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loteprednol Etabonate 0.5% Oph Gel | Uncorrected Visual Acuity | -0.078 logMAR | Standard Deviation 0.1 |
| Prednisolone Acetate 1% Oph Susp | Uncorrected Visual Acuity | -0.075 logMAR | Standard Deviation 0.09 |