Trial Outcomes & Findings for Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study (NCT NCT02575911)

NCT ID: NCT02575911

Last Updated: 2018-07-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: Month 3 postoperative
• Results posted on: 2018-07-02

Participant Flow

Participants were recruited from 2 sites located in the US.

Of the 34 enrolled, 4 participants were exited as screen failures prior to surgery. This reporting group includes all treated participants (30).

Participant milestones

Measure	LenSx LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	LenSx LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	LenSx n=30 Participants LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Age, Continuous	34.5 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 3 postoperative

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

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.

Outcome measures

Measure	LenSx n=58 Eyes LASIK surgery in both eyes using LenSx® Femtosecond Laser System	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative	125.8 micrometers Standard Deviation 4.8	—	—

SECONDARY outcome

Timeframe: Month 1 postoperative

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

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.

Outcome measures

Measure	LenSx n=58 Eyes LASIK surgery in both eyes using LenSx® Femtosecond Laser System	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative	127.8 micrometers Standard Deviation 3.7	—	—

SECONDARY outcome

Timeframe: Month 1, Month 3 postoperative

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

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.

Outcome measures

Measure	LenSx n=58 Eyes LASIK surgery in both eyes using LenSx® Femtosecond Laser System	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative Month 1 postoperative	127.8 micrometers Standard Deviation 3.7	—	—
Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative Month 3 postoperative	125.8 micrometers Standard Deviation 4.8	—	—

SECONDARY outcome

Timeframe: Day 0, operative day

Population: Safety Analysis Set

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.

Outcome measures

Measure	LenSx n=60 Eyes LASIK surgery in both eyes using LenSx® Femtosecond Laser System	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
Ease of Flap Dissection at Day 0, Operative Day	4.7 units on a scale Standard Deviation 0.5	—	—

SECONDARY outcome

Timeframe: Day 0, operative day

Population: Safety Analysis Set

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.

Outcome measures

Measure	LenSx n=60 Eyes LASIK surgery in both eyes using LenSx® Femtosecond Laser System	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
Stromal Bed Quality at Day 0, Operative Day	5.0 units on a scale Standard Deviation 0.0	—	—

SECONDARY outcome

Timeframe: Day 0, operative day

Population: Safety Analysis Set

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.

Outcome measures

Measure	LenSx n=60 Eyes LASIK surgery in both eyes using LenSx® Femtosecond Laser System	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
Opaque Bubble Layer (OBL) at Day 0, Operative Day	0.3 units on a scale Standard Deviation 0.4	—	—

SECONDARY outcome

Timeframe: Month 1, Month 3 postoperative

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

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.

Outcome measures

Measure	LenSx n=58 Eyes LASIK surgery in both eyes using LenSx® Femtosecond Laser System	LenSx - Month 3 Postoperative n=58 Eyes LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative ≤ 20/15	0.0 percentage of eyes	0.0 percentage of eyes	—
Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative 20/20	81.0 percentage of eyes	84.5 percentage of eyes	—
Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative 20/25	8.6 percentage of eyes	6.9 percentage of eyes	—
Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative 20/30	5.2 percentage of eyes	3.4 percentage of eyes	—
Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative 20/40	0.0 percentage of eyes	3.4 percentage of eyes	—
Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative >20/40	5.2 percentage of eyes	1.7 percentage of eyes	—

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 3 postoperative

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

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.

Outcome measures

Measure	LenSx n=60 Eyes LASIK surgery in both eyes using LenSx® Femtosecond Laser System	LenSx - Month 3 Postoperative n=58 Eyes LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative	LenSx - Month 3 Postoperative n=58 Eyes LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
Best Corrected Distance Visual Acuity (BCDVA) by Visit ≤ 20/15	0.0 percentage of eyes	1.7 percentage of eyes	0.0 percentage of eyes
Best Corrected Distance Visual Acuity (BCDVA) by Visit 20/20	91.7 percentage of eyes	91.4 percentage of eyes	98.3 percentage of eyes
Best Corrected Distance Visual Acuity (BCDVA) by Visit 20/25	8.3 percentage of eyes	3.4 percentage of eyes	1.7 percentage of eyes
Best Corrected Distance Visual Acuity (BCDVA) by Visit 20/30	0.0 percentage of eyes	0.0 percentage of eyes	0.0 percentage of eyes
Best Corrected Distance Visual Acuity (BCDVA) by Visit 20/40	0.0 percentage of eyes	1.7 percentage of eyes	0.0 percentage of eyes
Best Corrected Distance Visual Acuity (BCDVA) by Visit >20/40	0.0 percentage of eyes	1.7 percentage of eyes	0.0 percentage of eyes

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 3 postoperative

Population: This analysis population includes number of eyes in specified category.

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.

Outcome measures

Measure	LenSx n=60 Eyes LASIK surgery in both eyes using LenSx® Femtosecond Laser System	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
Manifest Refraction Spherical Equivalent (MRSE) Baseline	-2.846 diopter Standard Deviation 2.090	—	—
Manifest Refraction Spherical Equivalent (MRSE) Month 1 postoperative	-0.194 diopter Standard Deviation 0.329	—	—
Manifest Refraction Spherical Equivalent (MRSE) Month 3 postoperative	-0.166 diopter Standard Deviation 0.307	—	—

SECONDARY outcome

Timeframe: Month 1, Month 3 postoperative

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

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

Outcome measures

Measure	LenSx n=58 Eyes LASIK surgery in both eyes using LenSx® Femtosecond Laser System	LenSx - Month 3 Postoperative n=58 Eyes LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative	LenSx - Month 3 Postoperative LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op 0.5 diopter (D)	93.1 percentage of eyes	91.4 percentage of eyes	—
Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op 1.0 D	98.3 percentage of eyes	100.0 percentage of eyes	—

Adverse Events

Pre-treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LenSx

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pre-treatment n=68 participants at risk All who consented to participate in the study prior to the initiation of study treatment	LenSx n=60 participants at risk All subjects treated with LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Eye disorders Corneal striae	0.00% 0/68 • 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." 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.	1.7% 1/60 • 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." 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.

Other adverse events

Measure	Pre-treatment n=68 participants at risk All who consented to participate in the study prior to the initiation of study treatment	LenSx n=60 participants at risk All subjects treated with LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Eye disorders Punctate keratitis	0.00% 0/68 • 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." 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.	11.7% 7/60 • 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." 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.

Additional Information

Global Brand Med Affairs Lead, CDMA Surgical

Alcon, A Novartis Division

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
• Publication restrictions are in place

Restriction type: OTHER