Tissue Sealant Use in LASIK Enhancement Surgery
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - 99 |
| Updated: | 4/26/2018 |
| Start Date: | October 2016 |
| End Date: | January 2020 |
| Contact: | Edward E Manche, MD |
| Email: | lasik.manche@stanford.edu |
| Phone: | 650 498-7020 |
A Prospective Evaluation of Tissue Sealant to Prevent Epithelial Ingrowth in Repeat LASIK Surgery
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
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.
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.
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.
We found this trial at
1
site
Palo Alto, California 94303
Principal Investigator: Edward E Manche, MD
Phone: 650-498-7020
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