Trial · NCT02528123
VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia
NCT02528123, Not applicable, Completed, London Vision Clinic; results first posted 2024-04-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia. Trials, record NCT02528123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02528123
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia
- NCT number
- NCT02528123
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 114 participants, actual
- Lead sponsor
- London Vision Clinic
- Conditions
- Myopia, Refractive Errors
- Interventions
- Small incision lenticule extraction, Tobramycin and dexamethasone, Ofloxacin, Proxymetacaine 0.5%, Oxybuprocaine 0.4%
- First posted
- 2015-08-19
- Last updated
- 2024-04-23
- Results first posted
- 2024-04-23
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Variability of the Refractive Predicatibility | 1 year postop | Calculate the standard deviation of the postoperative spherical equivalent, adjusted relative to the intended target, after the SMILE procedure. Analysis performed on the data from the 1 year postoperative visit. An accurate outcome is where the postoperative spherical equivalent is equal to the intended target spherical equivalent. A mean difference less than zero implies the outcome was undercorrected, whereas a mean difference greater than zero implies the outcomes was overcorrected. A smaller standard deviation represents a more accurate and more predictable outcome. |
| Secondary | Efficacy of Uncorrected Distance Visual Acuity | 1 year postop | Measure the uncorrected distance visual acuity achieved after the SMILE procedure relative to the preoperative CDVA for all eyes where the intended target refraction was emmetropia. Analysis performed on the data from the 1 year postoperative visit. |
| Secondary | Safety of Corrected Distance Visual Acuity (Change in Corrected Distance Visual Acuity) | 1 year postop | Assess the change in corrected distance visual acuity (CDVA) before and after the SMILE procedure. Analysis performed on the data from the 1 year postoperative visit. |
| Secondary | Predictability of Refractive Correction | 1 year postop | Measure the postoperative refraction and calculate the deviation from the intended target in terms of spherical equivalent. Mean, standard deviation and range will be calculated. The data will also be analyzed as a scatter plot by plotting the attempted vs achieved spherical equivalent refraction. The data will also be graphically displayed as a histogram. Analysis performed on the data from the 1 year postoperative visit. |
| Secondary | Predictability of Refractive Astigmatism Correction | 1 year postop | Measure the postoperative refractive astigmatism and calculate the deviation from the intended target. Mean, standard deviation and range will be calculated. The data will also be analyzed as a scatter plot by plotting the target induced astigmatism vs the surgically induced astigmatism. The data will also be graphically displayed as a histogram. Analysis performed on the data from the 1 year postoperative visit. |
| Secondary | Stability of the Spherical Equivalent Refraction | 3 months and 1 year postop | Measure the postoperative refraction at 3 months and 12 months after the SMILE procedure and calculate the mean and standard deviation of spherical equivalent refraction for each time point. |
| Secondary | Change in Night Vision Disturbances (Questionnaire) | 1 year postop | Provide the patient with a questionnaire to subjectively grade their quality of vision at night to assess whether this has changed after the SMILE procedure. Analysis performed on the data from the 1 year postoperative visit. A Rasch scale of 0-100 was used. A score of 0 indicates no quality of vision disturbances. A score of 100 indicates severe quality of vision disturbances. The outcome is calculated as the difference between the Rasch score before and after surgery, reported as the change in Rasch score units. |
| Secondary | Change in Corneal Higher Order Aberrations | 1 year postop | Measure the corneal aberrations before and after the SMILE procedure using the Atlas topographer to evaluate the change in corneal aberrations due to the surgery. Analysis performed on the data from the 1 year postoperative visit. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Variability of the Refractive Predicatibility | 1 year postop | Calculate the standard deviation of the postoperative spherical equivalent, adjusted relative to the intended target, after the SMILE procedure. Analysis performed on the data from the 1 year postoperative visit. An accurate outcome is where the postoperative spherical equivalent is equal to the intended target spherical equivalent. A smaller standard deviation represents a more accurate and more predictable outcome. | Diopters | MEAN |
| SECONDARY | Efficacy of Uncorrected Distance Visual Acuity | 1 year postop | Percentage of eyes where the postop uncorrected distance visual acuity (UDVA) was within 1 line of preop corrected distance visual acuity (CDVA) | Percentage of eyes | NUMBER |
| SECONDARY | Safety of Corrected Distance Visual Acuity (Change in Corrected Distance Visual Acuity) | 1 year postop | Percentage of eyes with loss of 2 or more lines of corrected distance visual acuity (CDVA) | Percentage of eyes | NUMBER |
| SECONDARY | Predictability of Refractive Correction | 1 year postop | Percentage of eyes with spherical equivalent refraction within +/- 1.00 D of the intended target | Percentage of eyes | NUMBER |
| SECONDARY | Predictability of Refractive Astigmatism Correction | 1 year postop | Percentage of eyes with refractive cylinder up to 1.00 D after SMILE | Percentage of eyes | NUMBER |
| SECONDARY | Stability of the Spherical Equivalent Refraction | 3 months and 1 year postop | Percentage of eyes with change in SEQ more than 0.50 D between 3 and 12 months | Percentage of eyes | NUMBER |
| SECONDARY | Change in Night Vision Disturbances (Questionnaire) | 1 year postop | Change in total mean Rasch-scaled quality of vision score (including all symptoms) for bothersomeness | scores on the Rasch scale | MEAN |
| SECONDARY | Change in Corneal Higher Order Aberrations | 1 year postop | Change in corneal spherical aberration between 3 and 12 months | Microns change spherical aberration | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Variability of the Refractive Predicatibility | Small Incision Lenticule Extraction | -0.22 | Standard Deviation 0.48 | Diopters | |
| Efficacy of Uncorrected Distance Visual Acuity | Small Incision Lenticule Extraction | 87 | Percentage of eyes | ||
| Safety of Corrected Distance Visual Acuity (Change in Corrected Distance Visual Acuity) | Small Incision Lenticule Extraction | 0 | Percentage of eyes | ||
| Predictability of Refractive Correction | Small Incision Lenticule Extraction | 96 | Percentage of eyes | ||
| Predictability of Refractive Astigmatism Correction | Small Incision Lenticule Extraction | 93 | Percentage of eyes | ||
| Stability of the Spherical Equivalent Refraction | Small Incision Lenticule Extraction | 8 | Percentage of eyes | ||
| Change in Night Vision Disturbances (Questionnaire) | Small Incision Lenticule Extraction | 11 | Standard Deviation 23 | scores on the Rasch scale | |
| Change in Corneal Higher Order Aberrations | Small Incision Lenticule Extraction | 0.41 | Standard Deviation 0.16 | Microns change spherical aberration |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Small Incision Lenticule Extraction | 114 | 187 |
| Overall Study | COMPLETED | Small Incision Lenticule Extraction | 113 | 185 |
| Overall Study | NOT COMPLETED | Small Incision Lenticule Extraction | 1 | 2 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Corneal ectasia | Eye disorders | Small Incision Lenticule Extraction | 1 | 114 | 1 |
| other | Subjective visual disturbance | Eye disorders | Small Incision Lenticule Extraction | 9 | 114 | 9 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Small Incision Lenticule Extraction | 0 | 114 |
| Total, other adverse events | Small Incision Lenticule Extraction | 10 | 114 |
| Total, serious adverse events | Small Incision Lenticule Extraction | 0 | 114 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02528123
GET https://conductscience.org/api/trials/v1/NCT02528123/registered