Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Comparing LASIK outcomes using two femtosecond lasers
Patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the patient from the study, then the investigator will inform the patient and make an appropriate referral. Patients deemed appropriate for the study after a comprehensive examination including computerized videokeratography can be enrolled. Patients will undergo bilateral simultaneous eye surgery. Which eye is treated with the Intralase IFS 150 and which eye is treated with VisuMax will be randomized so there is a 50% chance for either eye to receive one treatment. Patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. Patients will receive topical antibiotics in each eye for one week following the procedure. Patients will receive pred forte 1% ophthalmic drops for one week after treatment. Patients will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralase IFS | Active Comparator | Intralase IFS vs. Visumax |
|
| Visumax | Active Comparator | Visumax vs. Intralase iFS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralase IFS150 | Device | Intralase flap creation |
| |
| Visumax |
| Measure | Description | Time Frame |
|---|---|---|
| ETDRS Uncorrected Visual Acuity | Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts | At post-operative month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness | Anterior segment ocular coherence tomography | At postoperative month one |
| Cochet Bonnet Asthesiometry Measurement of Corneal Sensation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Edward Manche, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford | Palo Alto | California | 94303 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intralase IFS Eye | Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye. |
| FG001 | Visumax Eye | Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | ETDRS Uncorrected Visual Acuity | Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts | Posted | Count of Units | Eyes | At post-operative month 12 | Eyes | Eyes |
|
Twelve months
Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the treated eye.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intralase IFS Eye | Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye. |
Not provided
Not provided
The study did not meet its planned enrollment number
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward E. Manche | Stanford University School of Medicine | 6507255765 | edward.manche@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2018 | Nov 10, 2021 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Eye to eye comparison
Not provided
Not provided
Not provided
Not provided
| Device |
Visumax flap creation |
|
Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal.
| At postoperative month twelve |
| Best Spectacle Corrected Visual Acuity | Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts | Postoperative month 12 |
| Aberrometry | Aberrometry images will be obtained on the iDesign aberrometer | One three, six and twelve months |
| Questionnaire Measuring Patient Preference for Laser Device | Participants were asked if they preferred having LASIK surgery with either the Visumax laser, the Intralase iFS laser or had no preference between the two lasers. | Intraoperative (Approximately 1 minute after completion of surgery) |
| Patient Reported Outcomes With LASIK | PROWL study questionnaire | One month, three months, six months and twelve months |
| Eyes |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
| Eyes |
|
|
| Secondary | Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness | Anterior segment ocular coherence tomography | Data were corrupted and could not be analyzed | Posted | At postoperative month one |
|
|
| Secondary | Cochet Bonnet Asthesiometry Measurement of Corneal Sensation | Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal. | Posted | Count of Units | Eyes | At postoperative month twelve | Eyes | Eyes |
|
|
|
| Secondary | Best Spectacle Corrected Visual Acuity | Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts | Posted | Count of Units | Eyes | Postoperative month 12 | Eyes | Eyes |
|
|
|
| Secondary | Aberrometry | Aberrometry images will be obtained on the iDesign aberrometer | The data were corrupted and could not be analyzed | Posted | One three, six and twelve months |
|
|
| Secondary | Questionnaire Measuring Patient Preference for Laser Device | Participants were asked if they preferred having LASIK surgery with either the Visumax laser, the Intralase iFS laser or had no preference between the two lasers. | Posted | Count of Participants | Participants | Intraoperative (Approximately 1 minute after completion of surgery) |
|
|
|
| Secondary | Patient Reported Outcomes With LASIK | PROWL study questionnaire | Questionnaire data were corrupted and could not be analyzed. | Posted | One month, three months, six months and twelve months |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Visumax Eye | Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye. | 0 | 7 | 0 | 7 | 0 | 7 |
Not provided
Not provided
Not provided
| Measurements |
|---|
|