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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loteprednol Etabonate 0.5% Oph Gel | Active Comparator | 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. |
|
| Prednisolone acetate 1% Oph Susp | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loteprednol Etabonate 0.5% Oph Gel | Drug |
| ||
| Prednisolone Acetate 1% Oph Susp |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure (IOP) From Baseline Through Month 3 | Intraocular pressure will be measured by applanation tonometry | Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eyes With Corneal Haze | As determined by slit lamp examination | 12 months |
| Uncorrected Visual Acuity | Best uncorrected visual acuity will be measured at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Mifflin, MD | University of Utah Moran Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moran Eye Center - Midvalley Location | Murray | Utah | 84107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Prednisolone Acetate 1% Oph Susp |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Intraocular Pressure (IOP) From Baseline Through Month 3 | Intraocular pressure will be measured by applanation tonometry | Posted | Mean | Standard Deviation | mmHg | Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op |
|
3 years and 10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-visually significant corneal haze | Eye disorders | Non-systematic Assessment | Cornea haze |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Mifflin, MD | University of Utah Moran Eye Center | 801-213-4152 | Mark.Mifflin@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2018 | Jun 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003318 | Corneal Opacity |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| C009935 | prednisolone acetate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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Examiners are masked to the treatment arm when obtaining measurements of intraocular pressure (IOP) and grading corneal haze.
| Drug |
|
| 3 months |
| Best Corrected Visual Acuity at 3 Months | Best uncorrected visual acuity will be measured at 3 months | 3 months |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Intraocular Pressure | Mean | Standard Deviation | mmHg |
|
|
|
| Secondary | Number of Eyes With Corneal Haze | As determined by slit lamp examination | Posted | Count of Units | Eyes | 12 months | Eyes | Eyes |
|
|
|
| Secondary | Uncorrected Visual Acuity | Best uncorrected visual acuity will be measured at 3 months | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
|
| Secondary | Best Corrected Visual Acuity at 3 Months | Best uncorrected visual acuity will be measured at 3 months | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 3 |
| 57 |
| EG001 | 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 | 0 | 74 | 0 | 74 | 7 | 74 |
|
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |