Hyperopia, Myopia
Conditions
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.
Interventions
DEVICEFemtosecond Laser System
Used for the creation of a corneal flap in patients undergoing LASIK surgery
PROCEDURELASIK surgery
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 2 sites located in the US.
Pre-assignment details
Of the 34 enrolled, 4 participants were exited as screen failures prior to surgery. This reporting group includes all treated participants (30).
Participants by arm
| Arm | Count |
|---|---|
| LenSx LASIK surgery in both eyes using LenSx® Femtosecond Laser System | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | LenSx |
|---|---|
| Age, Continuous | 34.5 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 60 |
| other Total, other adverse events | 0 / 68 | 7 / 60 |
| serious Total, serious adverse events | 0 / 68 | 1 / 60 |
Outcome results
Primary
Flap Thickness Accuracy Within the Central Zone at 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.
Time frame: Month 3 postoperative
Population: This analysis population includes the number of eyes treated with surgery and data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LenSx | Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative | 125.8 micrometers | Standard Deviation 4.8 |
Secondary
Best Corrected Distance Visual Acuity (BCDVA) by 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.
Time frame: Baseline, Month 1, Month 3 postoperative
Population: This analysis population includes total number of eyes in specified category at visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LenSx | Best Corrected Distance Visual Acuity (BCDVA) by Visit | 20/25 | 8.3 percentage of eyes |
| LenSx | Best Corrected Distance Visual Acuity (BCDVA) by Visit | ≤ 20/15 | 0.0 percentage of eyes |
| LenSx | Best Corrected Distance Visual Acuity (BCDVA) by Visit | 20/30 | 0.0 percentage of eyes |
| LenSx | Best Corrected Distance Visual Acuity (BCDVA) by Visit | >20/40 | 0.0 percentage of eyes |
| LenSx | Best Corrected Distance Visual Acuity (BCDVA) by Visit | 20/40 | 0.0 percentage of eyes |
| LenSx | Best Corrected Distance Visual Acuity (BCDVA) by Visit | 20/20 | 91.7 percentage of eyes |
| LenSx - Month 3 Postoperative | Best Corrected Distance Visual Acuity (BCDVA) by Visit | 20/20 | 91.4 percentage of eyes |
| LenSx - Month 3 Postoperative | Best Corrected Distance Visual Acuity (BCDVA) by Visit | ≤ 20/15 | 1.7 percentage of eyes |
| LenSx - Month 3 Postoperative | Best Corrected Distance Visual Acuity (BCDVA) by Visit | 20/25 | 3.4 percentage of eyes |
| LenSx - Month 3 Postoperative | Best Corrected Distance Visual Acuity (BCDVA) by Visit | 20/30 | 0.0 percentage of eyes |
| LenSx - Month 3 Postoperative | Best Corrected Distance Visual Acuity (BCDVA) by Visit | 20/40 | 1.7 percentage of eyes |
| LenSx - Month 3 Postoperative | Best Corrected Distance Visual Acuity (BCDVA) by Visit | >20/40 | 1.7 percentage of eyes |
| LenSx - Month 3 Postoperative | Best Corrected Distance Visual Acuity (BCDVA) by Visit | ≤ 20/15 | 0.0 percentage of eyes |
| LenSx - Month 3 Postoperative | Best Corrected Distance Visual Acuity (BCDVA) by Visit | >20/40 | 0.0 percentage of eyes |
| LenSx - Month 3 Postoperative | Best Corrected Distance Visual Acuity (BCDVA) by Visit | 20/40 | 0.0 percentage of eyes |
| LenSx - Month 3 Postoperative | Best Corrected Distance Visual Acuity (BCDVA) by Visit | 20/25 | 1.7 percentage of eyes |
| LenSx - Month 3 Postoperative | Best Corrected Distance Visual Acuity (BCDVA) by Visit | 20/20 | 98.3 percentage of eyes |
| LenSx - Month 3 Postoperative | Best Corrected Distance Visual Acuity (BCDVA) by Visit | 20/30 | 0.0 percentage of eyes |
Secondary
Ease of Flap Dissection at 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.
Time frame: Day 0, operative day
Population: Safety Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LenSx | Ease of Flap Dissection at Day 0, Operative Day | 4.7 units on a scale | Standard Deviation 0.5 |
Secondary
Flap Thickness Accuracy Within the Central Zone at 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.
Time frame: Month 1 postoperative
Population: This analysis population includes the number of eyes treated with surgery and data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LenSx | Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative | 127.8 micrometers | Standard Deviation 3.7 |
Secondary
Flap Thickness Precision Within the Central Zone at Month 1 and 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.
Time frame: Month 1, Month 3 postoperative
Population: This analysis population includes the number of eyes treated with surgery and data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LenSx | Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative | Month 1 postoperative | 127.8 micrometers | Standard Deviation 3.7 |
| LenSx | 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
Manifest Refraction Spherical Equivalent (MRSE)
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
Population: This analysis population includes number of eyes in specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LenSx | Manifest Refraction Spherical Equivalent (MRSE) | Baseline | -2.846 diopter | Standard Deviation 2.09 |
| LenSx | Manifest Refraction Spherical Equivalent (MRSE) | Month 1 postoperative | -0.194 diopter | Standard Deviation 0.329 |
| LenSx | Manifest Refraction Spherical Equivalent (MRSE) | Month 3 postoperative | -0.166 diopter | Standard Deviation 0.307 |
Secondary
Opaque Bubble Layer (OBL) at 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.
Time frame: Day 0, operative day
Population: Safety Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LenSx | Opaque Bubble Layer (OBL) at Day 0, Operative Day | 0.3 units on a scale | Standard Deviation 0.4 |
Secondary
Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op
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
Population: This analysis population includes the number of eyes treated with surgery and data available at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LenSx | Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op | 0.5 diopter (D) | 93.1 percentage of eyes |
| LenSx | Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op | 1.0 D | 98.3 percentage of eyes |
| LenSx - Month 3 Postoperative | Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op | 0.5 diopter (D) | 91.4 percentage of eyes |
| LenSx - Month 3 Postoperative | Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op | 1.0 D | 100.0 percentage of eyes |
Secondary
Stromal Bed Quality at 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.
Time frame: Day 0, operative day
Population: Safety Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LenSx | Stromal Bed Quality at Day 0, Operative Day | 5.0 units on a scale | Standard Deviation 0 |
Secondary
Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and 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.
Time frame: Month 1, Month 3 postoperative
Population: This analysis population includes the number of eyes treated with surgery and data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LenSx | Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative | ≤ 20/15 | 0.0 percentage of eyes |
| LenSx | Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative | 20/20 | 81.0 percentage of eyes |
| LenSx | Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative | 20/25 | 8.6 percentage of eyes |
| LenSx | Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative | 20/30 | 5.2 percentage of eyes |
| LenSx | Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative | 20/40 | 0.0 percentage of eyes |
| LenSx | Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative | >20/40 | 5.2 percentage of eyes |
| LenSx - Month 3 Postoperative | Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative | 20/40 | 3.4 percentage of eyes |
| LenSx - Month 3 Postoperative | Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative | ≤ 20/15 | 0.0 percentage of eyes |
| LenSx - Month 3 Postoperative | Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative | 20/30 | 3.4 percentage of eyes |
| LenSx - Month 3 Postoperative | Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative | 20/20 | 84.5 percentage of eyes |
| LenSx - Month 3 Postoperative | Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative | >20/40 | 1.7 percentage of eyes |
| LenSx - Month 3 Postoperative | Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative | 20/25 | 6.9 percentage of eyes |