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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eyes undergoing LASIK enhancement | Other | Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tissue sealant | Drug | Application of tissue sealant on eyes undergoing LASIK enhancement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap | The number of eyes that developed epithelial ingrowth under LASIK flap | At post-operative month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Refraction | Number of eyes within 0.5 diopters of the intended correction | At post-operative month 3 |
| Best-corrected Visual Acuity | Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward E Manche, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford | Palo Alto | California | 94303 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eyes Undergoing LASIK Enhancement | Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eyes Undergoing LASIK Enhancement | Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth |
| 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 | Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap | The number of eyes that developed epithelial ingrowth under LASIK flap | Posted | Count of Units | Eyes | At post-operative month 3 | Eyes | Eyes |
|
|
3 months
Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treated eye.
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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 | Eyes Undergoing LASIK Enhancement | Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth. |
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The study did not meet its planned enrollment number
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward E. Manche | Stanford University School of Medicine | 6507255765 | edward.manche@stanford.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 | Sep 20, 2016 | Nov 10, 2021 | Prot_SAP_000.pdf |
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| At post-operative month 3 |
| Uncorrected Visual Acuity | Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts | At post-operative month 3 |
| Eyes |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
| Eyes |
|
|
| Secondary | Change in Refraction | Number of eyes within 0.5 diopters of the intended correction | Posted | Count of Units | Eyes | At post-operative month 3 | Eyes | Eyes |
|
|
|
| Secondary | Best-corrected Visual Acuity | Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts | Posted | Count of Units | Eyes | At post-operative month 3 | Eyes | Eyes |
|
|
|
| Secondary | Uncorrected Visual Acuity | Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts | Posted | Count of Units | Eyes | At post-operative month 3 | Eyes | Eyes |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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