Refractive Surgery Clinical Trial
— AtLASOfficial title:
DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK
Verified date | February 2020 |
Source | Vance Thompson Vision |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral LASIK surgery.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 1, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Any adult patient who is planned to undergo bilateral LASIK surgery. - Refractive error between the 2 eyes of 2 Diopters or less - Willing and able to comply with clinic visits and study related procedures - Willing and able to sign the informed consent form Exclusion Criteria: - Patients under the age of 18. - Patients who choose to have monovision after LASIK - Patients with corneal pathology that may interfere with LASIK outcomes - Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test). - Active infectious ocular or systemic disease. - Patients with active infectious ocular or extraocular disease. - Patients actively treated with local or systemic immunosuppression including systemic corticosteroids. - Patients with known hypersensitivity to Dexamethasone. - Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator. - Patients with a history of ocular inflammation or macular edema. - Patients with allergy or inability to receive topical antibiotic. - Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day - Patients with a corticosteroid implant (i.e. Ozurdex). - Active or history of chronic or recurrent inflammatory eye disease in either eye - Ocular pain in either eye - Proliferative diabetic retinopathy in either eye - Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye - Laser or incisional ocular surgery during the study period and 6 months prior in either eye - History of cauterization of the punctum |
Country | Name | City | State |
---|---|---|---|
United States | Vance Thompson Vision ND | W. Fargo | North Dakota |
Lead Sponsor | Collaborator |
---|---|
Vance Thompson Vision |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety Endpoints | As measured by intraocular pressure increase of 10 mm Hg or greater from baseline. | Through Month 1 (Day 28 +/- 3 days) | |
Other | Safety Endpoints | As measured by proportion of eyes rescued with additional topical prednisolone treatment or increased frequency of dosing. | Through Month 1 (Day 28 +/- 3 days) | |
Other | Safety Endpoints | As measured by occurrence of adverse events. | Through Month 1 (Day 28 +/- 3 days) | |
Primary | Patient Preference | As measured by COMTOL adapted survey. | Through Month 1 (Day 28 +/- 3 days) | |
Primary | Patient Comfort | As measured by SPEED Questionnaire. | Through Month 1 (Day 28 +/- 3 days) | |
Secondary | Ocular Surface Health | As measured by corneal staining. | Through Month 1 (Day 28 +/- 3 days) | |
Secondary | Visual Outcomes | As measured by uncorrected Visual Acuity. | Through Month 1 (Day 28 +/- 3 days) | |
Secondary | Ocular Pain | As measured by Ocular Pain Assessment. | Through Month 1 (Day 28 +/- 3 days) |
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