Astigmatism, Myopia
Conditions
Keywords
Femtosecond laser, Visumax, Intralase IFS150, LASIK
Brief summary
Comparing LASIK outcomes using two femtosecond lasers
Detailed description
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.
Interventions
DEVICEIntralase IFS150
Intralase flap creation
DEVICEVisumax
Visumax flap creation
Sponsors
Edward E. Manche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Eye to eye comparison
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects age 21 and older with healthy eyes. Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters.
Exclusion criteria
* Subjects under the age of 21 * Subjects over the age of 60 * Subjects with corneal ectatic disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ETDRS Uncorrected Visual Acuity | At post-operative month 12 | Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cochet Bonnet Asthesiometry Measurement of Corneal Sensation | At postoperative month twelve | Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal. |
| Best Spectacle Corrected Visual Acuity | Postoperative month 12 | Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts |
| Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness | At postoperative month one | Anterior segment ocular coherence tomography |
| Questionnaire Measuring Patient Preference for Laser Device | Intraoperative (Approximately 1 minute after completion of surgery) | 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. |
| Patient Reported Outcomes With LASIK | One month, three months, six months and twelve months | PROWL study questionnaire |
| Aberrometry | One three, six and twelve months | Aberrometry images will be obtained on the iDesign aberrometer |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye. | 7 |
| All Participants Participants received treatment with Intralase IFS in one eye and treatment with Visumax in their fellow eye. | 14 |
| Total | 21 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Caucasian | 2 Participants |
| Region of Enrollment United States | 7 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
ETDRS Uncorrected Visual Acuity
Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts
Time frame: At post-operative month 12
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Intralase IFS Eye | ETDRS Uncorrected Visual Acuity | 5 Eyes |
| Visumax Eye | ETDRS Uncorrected Visual Acuity | 5 Eyes |
Secondary
Aberrometry
Aberrometry images will be obtained on the iDesign aberrometer
Time frame: One three, six and twelve months
Population: The data were corrupted and could not be analyzed
Secondary
Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness
Anterior segment ocular coherence tomography
Time frame: At postoperative month one
Population: Data were corrupted and could not be analyzed
Secondary
Best Spectacle Corrected Visual Acuity
Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts
Time frame: Postoperative month 12
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Intralase IFS Eye | Best Spectacle Corrected Visual Acuity | 0 Eyes |
| Visumax Eye | Best Spectacle Corrected Visual Acuity | 0 Eyes |
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.
Time frame: At postoperative month twelve
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Intralase IFS Eye | Cochet Bonnet Asthesiometry Measurement of Corneal Sensation | Score of greater than or equal to 5 | 7 Eyes |
| Intralase IFS Eye | Cochet Bonnet Asthesiometry Measurement of Corneal Sensation | Score of less than 5 | 0 Eyes |
| Visumax Eye | Cochet Bonnet Asthesiometry Measurement of Corneal Sensation | Score of greater than or equal to 5 | 7 Eyes |
| Visumax Eye | Cochet Bonnet Asthesiometry Measurement of Corneal Sensation | Score of less than 5 | 0 Eyes |
Secondary
Patient Reported Outcomes With LASIK
PROWL study questionnaire
Time frame: One month, three months, six months and twelve months
Population: Questionnaire data were corrupted and could not be analyzed.
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.
Time frame: Intraoperative (Approximately 1 minute after completion of surgery)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intralase IFS Eye | Questionnaire Measuring Patient Preference for Laser Device | Preferred Visumax | 3 Participants |
| Intralase IFS Eye | Questionnaire Measuring Patient Preference for Laser Device | Preferred Intralase IFS | 2 Participants |
| Intralase IFS Eye | Questionnaire Measuring Patient Preference for Laser Device | No preference | 2 Participants |