Epithelial Ingrowth
Conditions
Keywords
LASIK, Ingrowth, Tissue sealant
Brief summary
The purpose of the study is to evaluate the use of prophylactic tissue sealant to prevent epithelial ingrowth from gaining access under a LASIK flap with repeat LASIK surgery
Detailed description
Participants will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the participant from the study, then the participant will be informed and given an appropriate referral. If the participant is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The participant will undergo LASIK flap lift eye surgery. Tissue sealant will be applied at to the edge of the LASIK flap at the conclusion of the surgery. A bandage contact lens will also be placed. The bandage contact lens is used in the usual and customary fashion as in non-study LASIK flap lift surgery. The participants will be seen on the day of surgery, post op day one, one month, and three months. The participant will receive topical antibiotics in each eye for one week following the procedure. The participant will receive pred forte 1% ophthalmic drops for one week after treatment. The participant will also receive vigamox ophthalmic drops for seven days after treatment. All of this is within the usual and customary standard of care for the treatment of participants undergoing LASIK surgery.
Interventions
DRUGTissue sealant
Application of tissue sealant on eyes undergoing LASIK enhancement
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects age 21 and older * Subjects with healthy eyes * Subjects who have previously undergone LASIK surgery * Subjects with residual refractive error.
Exclusion criteria
* Subjects under the age of 21. * Subjects with excessively thin corneas. * Subjects with topographic evidence of keratoconus. * Subjects with ectatic eye disorders. * Subjects with autoimmune diseases. * Subjects who are pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap | At post-operative month 3 | The number of eyes that developed epithelial ingrowth under LASIK flap |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Refraction | At post-operative month 3 | Number of eyes within 0.5 diopters of the intended correction |
| Best-corrected Visual Acuity | At post-operative month 3 | Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts |
| Uncorrected Visual Acuity | At post-operative month 3 | Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eyes Undergoing LASIK Enhancement Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth | 2 |
| Eyes Undergoing LASIK Enhancement Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Eyes Undergoing LASIK Enhancement |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Region of Enrollment United States | 2 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap
The number of eyes that developed epithelial ingrowth under LASIK flap
Time frame: At post-operative month 3
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Eyes Undergoing LASIK Enhancement | Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap | 0 Eyes |
Secondary
Best-corrected Visual Acuity
Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts
Time frame: At post-operative month 3
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Eyes Undergoing LASIK Enhancement | Best-corrected Visual Acuity | 0 Eyes |
Secondary
Change in Refraction
Number of eyes within 0.5 diopters of the intended correction
Time frame: At post-operative month 3
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Eyes Undergoing LASIK Enhancement | Change in Refraction | 2 Eyes |
Secondary
Uncorrected Visual Acuity
Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts
Time frame: At post-operative month 3
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Eyes Undergoing LASIK Enhancement | Uncorrected Visual Acuity | 2 Eyes |