Trial Outcomes & Findings for Tissue Sealant Use in LASIK Enhancement Surgery (NCT NCT02952365)

Results Overview

The number of eyes that developed epithelial ingrowth under LASIK flap

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

At post-operative month 3

Results posted on

2021-12-14

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Eyes Undergoing LASIK Enhancement Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
Overall Study STARTED	2 2
Overall Study COMPLETED	2 2
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tissue Sealant Use in LASIK Enhancement Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eyes Undergoing LASIK Enhancement n=2 Eyes Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: At post-operative month 3

The number of eyes that developed epithelial ingrowth under LASIK flap

Outcome measures

Outcome measures
Measure	Eyes Undergoing LASIK Enhancement n=2 Eyes Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap	0 Eyes

SECONDARY outcome

Timeframe: At post-operative month 3

Number of eyes within 0.5 diopters of the intended correction

Outcome measures

Outcome measures
Measure	Eyes Undergoing LASIK Enhancement n=2 Eyes Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
Change in Refraction	2 Eyes

SECONDARY outcome

Timeframe: At post-operative month 3

Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts

Outcome measures

Outcome measures
Measure	Eyes Undergoing LASIK Enhancement n=2 Eyes Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
Best-corrected Visual Acuity	0 Eyes

SECONDARY outcome

Timeframe: At post-operative month 3

Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts

Outcome measures

Outcome measures
Measure	Eyes Undergoing LASIK Enhancement n=2 Eyes Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
Uncorrected Visual Acuity	2 Eyes

Adverse Events

Eyes Undergoing LASIK Enhancement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Edward E. Manche

Stanford University School of Medicine

Phone: 6507255765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place