Tissue Sealant Use in LASIK Enhancement Surgery

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02952365
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Epithelial Ingrowth	Drug: Tissue sealant	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Prospective Evaluation of Tissue Sealant to Prevent Epithelial Ingrowth in Repeat LASIK Surgery
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: May 22, 2017
• Actual Study Completion Date: May 22, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Eyes undergoing LASIK enhancement Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth	Drug: Tissue sealant; Application of tissue sealant on eyes undergoing LASIK enhancement; Other Names: ReSure sealant

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Change in Refraction [At post-operative month 3]

   Number of eyes within 0.5 diopters of the intended correction

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Byers Eye Institute at Stanford	Palo Alto	California	United States	94303

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Edward E Manche, MD, Stanford University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 20, 2016

More Information

Publications

None provided.

• Responsible Party: Edward E. Manche, Principal Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT02952365
• Other Study ID Numbers: IRB-38495
• First Posted: Nov 2, 2016
• Last Update Posted: Dec 14, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Edward E. Manche, Principal Investigator, Stanford University: LASIK, Ingrowth, Tissue sealant

Study Results

Participant Flow

Arm/Group Title	Eyes Undergoing LASIK Enhancement
Arm/Group Description	Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
Period Title: Overall Study
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Eyes Undergoing LASIK Enhancement
Arm/Group Description	Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
Overall Participants	2
Overall Eyes	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%
Race/Ethnicity, Customized (Count of Participants)
Asian	2 100%
Region of Enrollment (Count of Participants)
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	Slit Lamp Examination for Presence of Epithelial Ingrowth Under LASIK Flap
Description	The number of eyes that developed epithelial ingrowth under LASIK flap
Time Frame	At post-operative month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eyes Undergoing LASIK Enhancement
Arm/Group Description	Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
Measure Participants	2
Measure Eyes	2
Count of Units [Eyes]	0

2. Secondary Outcome

Title	Change in Refraction
Description	Number of eyes within 0.5 diopters of the intended correction
Time Frame	At post-operative month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eyes Undergoing LASIK Enhancement
Arm/Group Description	Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
Measure Participants	2
Measure Eyes	2
Count of Units [Eyes]	2

3. Secondary Outcome

Title	Best-corrected Visual Acuity
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eyes Undergoing LASIK Enhancement
Arm/Group Description	Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
Measure Participants	2
Measure Eyes	2
Count of Units [Eyes]	0

4. Secondary Outcome

Title	Uncorrected Visual Acuity
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eyes Undergoing LASIK Enhancement
Arm/Group Description	Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth
Measure Participants	2
Measure Eyes	2
Count of Units [Eyes]	2

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treated eye.
Arm/Group Title	Eyes Undergoing LASIK Enhancement
Arm/Group Description	Eyes undergoing LASIK enhancement will have tissue sealant applied to the eye to prevent epithelial ingrowth.
All Cause Mortality
	Eyes Undergoing LASIK Enhancement
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Eyes Undergoing LASIK Enhancement
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Eyes Undergoing LASIK Enhancement
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

The study did not meet its planned enrollment number

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.