An interventional study of Topography Guided LASIK and Small Incision Lenticular Extraction in Myopia and Astigmatism, sponsored by Alcon, a Novartis Company. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-14.
Sponsored by Alcon, a Novartis Company (formerly part of Novartis) · Not applicable, Interventional, and Treatment
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's enrollment of 21 is below the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Alcon, a Novartis Company is the lead sponsor of 13 studies on the registry; none are open to participants now.
First submitted before Alcon left Novartis.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
Procedure: Topography Guided LASIK · Device: WaveLight EX500 Excimer Laser System
Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery
Procedure: Small Incision Lenticular Extraction · Device: VisuMax Surgical Laser
Corneal surgery for refractive error correction
Refractive surgical procedure for the correction of myopia with or without astigmatism
Also known as: SMILE
As used for corneal stroma ablation (refractive error correction). The treatment is intended to last the subject's lifetime.
As used for lenticule creation/removal (refractive error correction). The treatment is intended to last the subject's lifetime.
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
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
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
Subjects were recruited from 1 study center located in France.
| Milestone | LASIK | SMILE |
|---|---|---|
| Started | 10 | 10 |
| Completed | 0 | 0 |
| Not completed | 10 | 10 |
| Withdrew: Study terminated by sponsor | 10 | 10 |
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.
| percentage of eyes | LASIK | SMILE |
|---|---|---|
| Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months | 60 (26.2 to 87.8) | 100.0 (76.8 to 100.0) |
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.
| Diopters | LASIK | SMILE |
|---|---|---|
| Mean Manifest Refraction Cylinder at 3 Months | -0.575 ± 0.4091 | -0.232 ± 0.1539 |
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.
| logMAR | LASIK | SMILE |
|---|---|---|
| Mean Uncorrected Visual Acuity (UCVA) at 3 Months | -0.100 ± 0.1360 | -0.164 ± 0.0769 |
Collected over Surgery through study completion, an average of 3 months, per the early termination criteria.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LASIK | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| SMILE | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
This analysis population includes all eyes of randomized subjects for whom the treatment was initiated (Intent to treat Analysis Set) (ITT).
| Age, Customized(Participants) | LASIK | SMILE | Total |
|---|---|---|---|
| < 65 years | 10 | 10 | 20 |
| ≥ 65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | LASIK | SMILE | Total |
|---|---|---|---|
| Female | 7 | 6 | 13 |
| Male | 3 | 4 | 7 |
| Ethnicity (NIH/OMB)(Participants) | LASIK | SMILE | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 3 | 5 | 8 |
| Unknown or Not Reported | 6 | 5 | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2017 to primary completion in Jul 2017, 4 months.
Results were first posted in Jan 2019, 1 year 5 months after primary completion.
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