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management decision; non patient safety related reason
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LASIK with EX500 | Experimental | Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery |
|
| SMILE with VisuMax | Active Comparator | Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topography Guided LASIK | Procedure | Corneal surgery for refractive error correction |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alcon, A Novartis Division | Alcon, A Novartis Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Paris | 75008 | France |
Of the 21 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (20).
Subjects were recruited from 1 study center located in France.
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| ID | Title | Description |
|---|---|---|
| FG000 | LASIK | Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery |
| FG001 | SMILE | Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population includes all eyes of randomized subjects for whom the treatment was initiated (Intent to treat Analysis Set) (ITT).
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| ID | Title | Description |
|---|---|---|
| BG000 | LASIK | Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery |
| BG001 | SMILE | Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT with non-missing data | Posted | Number | 95% Confidence Interval | percentage of eyes | Month 3 | Eyes | Eyes |
|
Surgery through study completion, an average of 3 months, per the early termination criteria.
An adverse event (AE) is 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 investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LASIK | Subjects exposed to topography guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Global Brand Medical Affairs Lead, CDMA Surgical | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2017 | Jul 9, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 19, 2016 | Jul 9, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Small Incision Lenticular Extraction |
| Procedure |
Refractive surgical procedure for the correction of myopia with or without astigmatism |
|
|
| WaveLight EX500 Excimer Laser System | Device | As used for corneal stroma ablation (refractive error correction). The treatment is intended to last the subject's lifetime. |
|
| VisuMax Surgical Laser | Device | As used for lenticule creation/removal (refractive error correction). The treatment is intended to last the subject's lifetime. |
|
| Month 3 |
| 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. | Month 3 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| SMILE |
Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery |
|
|
| 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. | ITT with non-missing data | Posted | Mean | Standard Deviation | Diopters | Month 3 | Eyes | Eyes |
|
|
|
| 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. | ITT with non-missing data | Posted | Mean | Standard Deviation | logMAR | Month 3 | Eyes | Eyes |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | SMILE | Subjects exposed to SMILE with VisuMax laser in bilateral surgery | 0 | 10 | 0 | 10 | 0 | 10 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.