Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02575911
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.4
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia	Device: Femtosecond Laser System; Procedure: LASIK surgery	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
• Actual Study Start Date: Oct 28, 2015
• Actual Primary Completion Date: Apr 9, 2016
• Actual Study Completion Date: Apr 9, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LenSx LASIK surgery in both eyes using LenSx® Femtosecond Laser System	Device: Femtosecond Laser System; Used for the creation of a corneal flap in patients undergoing LASIK surgery; Other Names: LenSx® ; Procedure: LASIK surgery

Outcome Measures

Primary Outcome Measures

1. Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative [Month 3 postoperative]

   Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.

Secondary Outcome Measures

1. Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative [Month 1 postoperative]

   Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.

2. Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative [Month 1, Month 3 postoperative]

   Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness precision (variability of the achieved flap thickness) was defined as the standard deviation of the flap thickness measurement. Each eye contributed separately to the analysis.

3. Ease of Flap Dissection at Day 0, Operative Day [Day 0, operative day]

   Ease of flap dissection (ease of lifting the flap during surgery) was assessed on a scale from 0 to 5 where 0 = Unable to lift flap and 5 = Able to lift flap without any resistance using blunt instrument. Each eye contributed separately to the analysis.

4. Stromal Bed Quality at Day 0, Operative Day [Day 0, operative day]

   Stromal bed quality was assessed by the investigator on a roughness scale from 0 to 5 where 0 = Very rough surface and 5 = Very smooth surface. Each eye contributed separately to the analysis.

5. Opaque Bubble Layer (OBL) at Day 0, Operative Day [Day 0, operative day]

   Opaque bubble layer was assessed by the investigator during the surgery on a scale from 0 to 5 where 0 = No OBL and 5 = 100% OBL in the stromal bed area. Each eye contributed separately to the analysis.

6. Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative [Month 1, Month 3 postoperative]

   UCDVA (measurement of uncorrected (without spectacles or other visual corrective devices) distance visual acuity) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.

7. Best Corrected Distance Visual Acuity (BCDVA) by Visit [Baseline, Month 1, Month 3 postoperative]

   BCDVA (measurement with the participant's best spectacle correction) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.

8. Manifest Refraction Spherical Equivalent (MRSE) [Baseline, Month 1, Month 3 postoperative]

   The participant was manually refracted to his/her best correction using a phoropter and standard Snellen eye charts. Each eye contributed separately to the analysis.

9. Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op [Month 1, Month 3 postoperative]

   Prediction error was summarized as a percentage of eyes within 0.5 D and 1.0 D of target at one and three months postoperative

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with myopia or hyperopia and eligible for femtosecond laser initiated LASIK surgery;

• Best corrected visual acuity (BCVA) correctable to at least 20/25 in each eye;

• If contact lens wearer, willing to discontinue contact lens wear prior to screening procedures;

• Willing and able to return for ALL scheduled follow-up examinations;

• Willing and able to provide written informed consent;

• Eligible for bilateral LASIK procedures to be done on the same day;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Previous corneal surgery, corneal lesions that will impede laser treatment, corneal edema, hypotony, glaucoma, existing corneal implant, or keratoconus;

• Known sensitivity to planned study concomitant medications;

• Participation in any other ophthalmic drug or device clinical study for 30 days prior to or during the time of participation in this study;

• Irregular astigmatism, based on the Investigator's judgement;

• Pregnant, lactating or planning to become pregnant during the course of the study;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Clinical Trial Manager, GCRA, Alcon, A Novartis Division

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02575911
• Other Study ID Numbers: CTJ121-P001
• First Posted: Oct 15, 2015
• Last Update Posted: Jul 2, 2018
• Last Verified: Apr 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Hyperopia

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 2 sites located in the US.
Pre-assignment Detail	Of the 34 enrolled, 4 participants were exited as screen failures prior to surgery. This reporting group includes all treated participants (30).

Arm/Group Title	LenSx
Arm/Group Description	LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Period Title: Overall Study
STARTED	30
COMPLETED	29
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	LenSx
Arm/Group Description	LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.5 (11.0)
Sex: Female, Male (Count of Participants)
Female	16 53.3%
Male	14 46.7%

Outcome Measures

1. Primary Outcome

Title	Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative
Description	Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.
Time Frame	Month 3 postoperative

Outcome Measure Data

Analysis Population Description

This analysis population includes the number of eyes treated with surgery and data available.

Arm/Group Title	LenSx
Arm/Group Description	LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Measure Participants	29
Measure Eyes	58
Mean (Standard Deviation) [micrometers]	125.8 (4.8)

2. Secondary Outcome

Title	Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative
Description	Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.
Time Frame	Month 1 postoperative

Outcome Measure Data

Analysis Population Description

This analysis population includes the number of eyes treated with surgery and data available.

Arm/Group Title	LenSx
Arm/Group Description	LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Measure Participants	29
Measure Eyes	58
Mean (Standard Deviation) [micrometers]	127.8 (3.7)

3. Secondary Outcome

Title	Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative
Description	Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness precision (variability of the achieved flap thickness) was defined as the standard deviation of the flap thickness measurement. Each eye contributed separately to the analysis.
Time Frame	Month 1, Month 3 postoperative

Outcome Measure Data

Analysis Population Description

This analysis population includes the number of eyes treated with surgery and data available.

Arm/Group Title	LenSx
Arm/Group Description	LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Measure Participants	29
Measure Eyes	58
Month 1 postoperative	127.8 (3.7)
Month 3 postoperative	125.8 (4.8)

4. Secondary Outcome

Title	Ease of Flap Dissection at Day 0, Operative Day
Description	Ease of flap dissection (ease of lifting the flap during surgery) was assessed on a scale from 0 to 5 where 0 = Unable to lift flap and 5 = Able to lift flap without any resistance using blunt instrument. Each eye contributed separately to the analysis.
Time Frame	Day 0, operative day

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	LenSx
Arm/Group Description	LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Measure Participants	30
Measure Eyes	60
Mean (Standard Deviation) [units on a scale]	4.7 (0.5)

5. Secondary Outcome

Title	Stromal Bed Quality at Day 0, Operative Day
Description	Stromal bed quality was assessed by the investigator on a roughness scale from 0 to 5 where 0 = Very rough surface and 5 = Very smooth surface. Each eye contributed separately to the analysis.
Time Frame	Day 0, operative day

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	LenSx
Arm/Group Description	LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Measure Participants	30
Measure Eyes	60
Mean (Standard Deviation) [units on a scale]	5.0 (0.0)

6. Secondary Outcome

Title	Opaque Bubble Layer (OBL) at Day 0, Operative Day
Description	Opaque bubble layer was assessed by the investigator during the surgery on a scale from 0 to 5 where 0 = No OBL and 5 = 100% OBL in the stromal bed area. Each eye contributed separately to the analysis.
Time Frame	Day 0, operative day

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	LenSx
Arm/Group Description	LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Measure Participants	30
Measure Eyes	60
Mean (Standard Deviation) [units on a scale]	0.3 (0.4)

7. Secondary Outcome

Title	Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative
Description	UCDVA (measurement of uncorrected (without spectacles or other visual corrective devices) distance visual acuity) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.
Time Frame	Month 1, Month 3 postoperative

Outcome Measure Data

Analysis Population Description

This analysis population includes the number of eyes treated with surgery and data available.

Arm/Group Title	LenSx - Month 1 Postoperative	LenSx - Month 3 Postoperative
Arm/Group Description	LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative	LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
Measure Participants	29	29
Measure Eyes	58	58
≤ 20/15	0.0	0.0
20/20	81.0	84.5
20/25	8.6	6.9
20/30	5.2	3.4
20/40	0.0	3.4
>20/40	5.2	1.7

8. Secondary Outcome

Title	Best Corrected Distance Visual Acuity (BCDVA) by Visit
Description	BCDVA (measurement with the participant's best spectacle correction) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.
Time Frame	Baseline, Month 1, Month 3 postoperative

Outcome Measure Data

Analysis Population Description

This analysis population includes total number of eyes in specified category at visit.

Arm/Group Title	Baseline	LenSx - Month 1 Postoperative	LenSx - Month 3 Postoperative
Arm/Group Description	Prior to LASIK surgery	LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative	LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
Measure Participants	30	29	29
Measure Eyes	60	58	58
≤ 20/15	0.0	1.7	0.0
20/20	91.7	91.4	98.3
20/25	8.3	3.4	1.7
20/30	0.0	0.0	0.0
20/40	0.0	1.7	0.0
>20/40	0.0	1.7	0.0

9. Secondary Outcome

Title	Manifest Refraction Spherical Equivalent (MRSE)
Description	The participant was manually refracted to his/her best correction using a phoropter and standard Snellen eye charts. Each eye contributed separately to the analysis.
Time Frame	Baseline, Month 1, Month 3 postoperative

Outcome Measure Data

Analysis Population Description

This analysis population includes number of eyes in specified category.

Arm/Group Title	LenSx
Arm/Group Description	LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Measure Participants	30
Measure Eyes	60
Baseline	-2.846 (2.090)
Month 1 postoperative	-0.194 (0.329)
Month 3 postoperative	-0.166 (0.307)

10. Secondary Outcome

Title	Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op
Description	Prediction error was summarized as a percentage of eyes within 0.5 D and 1.0 D of target at one and three months postoperative
Time Frame	Month 1, Month 3 postoperative

Outcome Measure Data

Analysis Population Description

This analysis population includes the number of eyes treated with surgery and data available at the specified time point.

Arm/Group Title	LenSx - 1 Month Postoperative	LenSx - 3 Months Postoperative
Arm/Group Description	LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative	LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
Measure Participants	29	29
Measure Eyes	58	58
0.5 diopter (D)	93.1	91.4
1.0 D	98.3	100.0

Adverse Events

Time Frame	Adverse events (AEs) were collected from time of consent for the duration of participation in the study (up to 5 months). AEs are reported as pre-treatment and treatment-emergent. "At Risk" population for ocular AEs is included with unit of "eyes."
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device.
Arm/Group Title	Pre-treatment		LenSx
Arm/Group Description	All who consented to participate in the study prior to the initiation of study treatment		All subjects treated with LASIK surgery in both eyes using LenSx® Femtosecond Laser System
All Cause Mortality
	Pre-treatment		LenSx
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/60 (0%)
Serious Adverse Events
	Pre-treatment		LenSx
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		1/60 (1.7%)
Eye disorders
Corneal striae	0/68 (0%)		1/60 (1.7%)
Other (Not Including Serious) Adverse Events
	Pre-treatment		LenSx
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		7/60 (11.7%)
Eye disorders
Punctate keratitis	0/68 (0%)		7/60 (11.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.