Astigmatism, Myopia
Conditions
Brief summary
The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for the treatment of myopia with astigmatism.
Interventions
PROCEDURETopography Guided LASIK
Corneal surgery for refractive error correction
PROCEDURESmall Incision Lenticular Extraction
Refractive surgical procedure for the correction of myopia with or without astigmatism
As used for corneal stroma ablation (refractive error correction). The treatment is intended to last the subject's lifetime.
DEVICEVisuMax Surgical Laser
As used for lenticule creation/removal (refractive error correction). The treatment is intended to last the subject's lifetime.
Sponsors
Alcon, a Novartis Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects in Singapore must be 21 years of age or older and subjects in Korea must be upon completion of 19 years of age or older due to local regulations; * Able to comprehend and sign an informed consent form; * Willing and able to complete all postoperative visits; * Myopia requiring (a) refractive error correction of -0.5 to -8.0 D optical infinity adjusted manifest refraction sphere with (b) astigmatism correction of -0.75 to -5.0 D manifest refraction cylinder and (c) at least 0.75 D of corneal astigmatism. * Intended treatment targeted for emmetropia; * Preoperative best-corrected visual acuity (BCVA) of 0 logMAR or better; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Pregnant or lactating, current or planned, during the course of the study; * Dry eye; * Corneal disease; * Diagnosis of advanced glaucoma; * Uncontrolled diabetes; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months | Month 3 | Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Manifest Refraction Cylinder at 3 Months | Month 3 | Manifest refraction cylinder was measured monocularly at 3 or 4 meters under photopic lighting conditions using a phoropter and ETDRS chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed. |
| Mean Uncorrected Visual Acuity (UCVA) at 3 Months | Month 3 | Uncorrected (without spectacles or other visual corrective devices) Visual Acuity (UCVA) testing was conducted monocularly in photopic conditions without glare at 3 or 4 meters. Visual Acuity (VA) is measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity. The Precision Vision illuminator cabinets and ETDRS charts were used. For subjects who could not read English letters, a numerical, Tumbling E logMAR chart was used. Since the study was terminated early, inferential statistics could not be completed. |
Countries
France
Participant flow
Recruitment details
Subjects were recruited from 1 study center located in France.
Pre-assignment details
Of the 21 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (20).
Participants by arm
| Arm | Count |
|---|---|
| LASIK Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery | 10 |
| SMILE Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated by sponsor | 10 | 10 |
Baseline characteristics
| Characteristic | LASIK | SMILE | Total |
|---|---|---|---|
| Age, Customized < 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Customized ≥ 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 5 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months
Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.
Time frame: Month 3
Population: ITT with non-missing data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LASIK | Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months | 60 percentage of eyes |
| SMILE | Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months | 100.0 percentage of eyes |
Secondary
Mean Manifest Refraction Cylinder at 3 Months
Manifest refraction cylinder was measured monocularly at 3 or 4 meters under photopic lighting conditions using a phoropter and ETDRS chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.
Time frame: Month 3
Population: ITT with non-missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LASIK | Mean Manifest Refraction Cylinder at 3 Months | -0.575 Diopters | Standard Deviation 0.4091 |
| SMILE | Mean Manifest Refraction Cylinder at 3 Months | -0.232 Diopters | Standard Deviation 0.1539 |
Secondary
Mean Uncorrected Visual Acuity (UCVA) at 3 Months
Uncorrected (without spectacles or other visual corrective devices) Visual Acuity (UCVA) testing was conducted monocularly in photopic conditions without glare at 3 or 4 meters. Visual Acuity (VA) is measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity. The Precision Vision illuminator cabinets and ETDRS charts were used. For subjects who could not read English letters, a numerical, Tumbling E logMAR chart was used. Since the study was terminated early, inferential statistics could not be completed.
Time frame: Month 3
Population: ITT with non-missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LASIK | Mean Uncorrected Visual Acuity (UCVA) at 3 Months | -0.100 logMAR | Standard Deviation 0.136 |
| SMILE | Mean Uncorrected Visual Acuity (UCVA) at 3 Months | -0.164 logMAR | Standard Deviation 0.0769 |