Collecting data using Kera Sol tear usage during the initial two-week post-operative period after Laser-Assisted In Situ Keratomileusis (LASIK) has on the signs and symptoms of surgical temporary ocular discomfort syndrome (STODS)
Prospective, single-site, two-arm randomized study evaluating the impact of, Kera Sol tears on the signs and symptoms of STODS in 60 patients who underwent bilateral LASIK. Both groups will be prescribed the standard of care post-operative prescription combination steroid and antibiotic drop. Additionally, subjects will be randomized to administer the study drop (Kera Sol) dosed QID for 14 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
Eye drops
Vance Thompson Vision Clinic, Prof. LLC
Sioux Falls, South Dakota, United States
RECRUITINGChange in Baseline of Corneal Staining
Using the National Eye Institute (NEI) scale system. The NEI scale system for grading fluorescein staining divides the corneal and conjunctival surfaces. The conjunctival surface is divided into 6 areas and the corneal surface is divided into 5 areas. A standardized grading system of 0 to 3 is used for each of areas on cornea and conjunctiva. The maximum staining score for the cornea is 15, and for conjunctiva, the maximum score is 18. The values above 3 is considered abnormal for cornea or conjunctiva in each eye. Grade 0 (i.e., no staining) indicates normal cornea or normal conjunctiva Grade 3 (i.e., highest severity staining) indicates severe ocular surface damage NEI Scale ranges from 0-4. Grade 0 = no dots; Grade 1 = 1-15 dots; Grade 2 = 16-30 dots, and Grade 3 = 31 or \> dots.
Time frame: 14 days
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