Phase 4 N=2 Prevention

Tissue Sealant Use in LASIK Enhancement Surgery

Epithelial Ingrowth

Bottom Line

View on ClinicalTrials.gov: NCT02952365 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2021

Primary outcome: Primary: Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap — 0 Eyes

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tissue sealant (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: May 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap	—	—
SECONDARY Change in Refraction	2	—
SECONDARY Best-corrected Visual Acuity	—	—
SECONDARY Uncorrected Visual Acuity	2	—

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02952365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.