Pain, Vision Nearsighted
Conditions
Keywords
Corneal shield, PRK, Myopia, Pain, Vision
Brief summary
The purpose of this research is to determine if an investigational thin shield over the cornea can safely and effectively reduce or eliminate pain following Post Photorefractive Keratectomy (PRK). The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye.
Detailed description
See above
Interventions
DEVICEEye Shield
The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
. * Subjects age 18 and older with healthy eyes. * Nearsightedness between -0.50 diopters and -11.00 diopters with or without astigmatism of up to 3.50 diopters.
Exclusion criteria
. * Subjects under the age of 18. * Patients with excessively thin corneas. * Patients with topographic evidence of keratoconus. * Patients with ectactic eye disorders. * Patients with autoimmune diseases. * Patients who are pregnant or nursing. * Any other anterior segment abnormality other than that associated with PRK * Any abnormalities associated with the eye lids * Uncontrolled blepharitis or dry eye * Prior laser treatment of the retina * Any ophthalmic surgery performed within three (3) months prior to study excluding PRK or LASIK * Diagnosis of glaucoma * Active diabetic retinopathy * Clinically significant inflammation or infection within six (6) months prior to study * Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator * Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational material * Intolerance or hypersensitivity to topical anesthetics, antibiotics, steroids or any other pharmaceuticals that may be used pre and post surgically Specifically known intolerance or hypersensitivity to contact lenses or any component of the investigative material * A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up * Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Pain Score of Four or Greater. Score Range: 0-10, Higher Score Corresponds to More Pain. | Day 30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Uncorrected Visual Acuity | Six months | LogMAR uncorrected visual acuity. Values closer to zero indicate improved vision |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eye Shield Participants receive eye shield during PRK surgery | 30 |
| Eye Shield Participants receive eye shield during PRK surgery | 45 |
| Total | 75 |
Baseline characteristics
| Characteristic | Eye Shield |
|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Number of Participants With Pain Score of Four or Greater. Score Range: 0-10, Higher Score Corresponds to More Pain.
Time frame: Day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eye Shield | Number of Participants With Pain Score of Four or Greater. Score Range: 0-10, Higher Score Corresponds to More Pain. | 0 Participants |
Secondary
Mean Change in Uncorrected Visual Acuity
LogMAR uncorrected visual acuity. Values closer to zero indicate improved vision
Time frame: Six months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eye Shield | Mean Change in Uncorrected Visual Acuity | Baseline | 1.34 logMAR | Standard Deviation 0.55 |
| Eye Shield | Mean Change in Uncorrected Visual Acuity | Month six | -0.06 logMAR | Standard Deviation 0.11 |