MyopiaNCT03063164
A Comparison of LASIK Outcomes Using Two Femtosecond Lasers
A study testing Intralase IFS150 and Visumax in people with Myopia and Astigmatism, run by Edward E. Manche at 1 site in United States.
Trial summary
Comparing LASIK outcomes using two femtosecond lasers Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Intralase IFS150 and Visumax
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2017to 13 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Subjects under the age of 21
- Subjects over the age of 60
- Subjects with corneal ectatic disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Byers Eye Institute at Stanford
Palo Alto, California, 94303
About this study
Official title: A Prospective, Randomized, Fellow Eye Comparison of Fellow Eyes Undergoing LASIK With the Intralase IFS150 Versus the Visumax
Comparing LASIK outcomes using two femtosecond lasers
Read the 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.
- Conditions
- Myopia, Astigmatism
- Being tested
- Intralase IFS150, Visumax
- Keywords
- Femtosecond laser, Visumax, Intralase IFS150, LASIK
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralase IFS150Device
Intralase flap creation
VisumaxDevice
Visumax flap creation
| Study group | Role | What they receive |
|---|---|---|
| Intralase IFS | Active comparator | Intralase IFS vs. Visumax Receives: Device: Intralase IFS150 |
| Visumax | Active comparator | Visumax vs. Intralase iFS Receives: Device: Visumax |
What is being measured
The primary outcome is the main question the study is designed to answer.
ETDRS Uncorrected Visual Acuity
Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts
Measured: At post-operative month 12
Secondary outcomes (6)
Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness
Anterior segment ocular coherence tomography
Measured: At postoperative month one
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.
Measured: 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
Measured: Postoperative month 12
Aberrometry
Aberrometry images will be obtained on the iDesign aberrometer
Measured: 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.
Measured: Intraoperative (Approximately 1 minute after completion of surgery)
Patient Reported Outcomes With LASIK
PROWL study questionnaire
Measured: One month, three months, six months and twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start14 Feb 2017
- Primary completion13 Nov 2018
- Study completion13 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eye to eye comparison
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward E. Manche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edward E. Manche, Stanford University
- Investigators
- Edward Manche, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063164
- Sponsor's protocol ID
- 33356
- Status last verified
- Nov 2021
- First submitted
- 11 Feb 2017
- Last updated
- 14 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Fellow Eye Comparison of Fellow Eyes Undergoing LASIK With the Intralase IFS150 Versus the Visumax
- ClinicalTrials.gov ID
- NCT03063164
- Acronym / sponsor ID
- 33356
- Conditions
- Myopia, Astigmatism
- Keywords
- Femtosecond laser, Visumax, Intralase IFS150, LASIK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Edward E. MancheUniversity, hospital or other
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Posted 14 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eye to eye comparison
| Arm | Type | Receives |
|---|---|---|
| Intralase IFS | Active comparator | Device: Intralase IFS150Intralase IFS vs. Visumax |
| Visumax | Active comparator | Device: VisumaxVisumax vs. Intralase iFS |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Subjects under the age of 21
- Subjects over the age of 60
- Subjects with corneal ectatic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intralase IFS150Intralase flap creation | Device | Intralase IFS |
| VisumaxVisumax flap creation | Device | Visumax |
Primary outcome
ETDRS Uncorrected Visual Acuity
Time frame: At post-operative month 12
Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts
6 secondary outcomes
Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness
Time frame: At postoperative month one
Cochet Bonnet Asthesiometry Measurement of Corneal Sensation
Time frame: At postoperative month twelve
Best Spectacle Corrected Visual Acuity
Time frame: Postoperative month 12
Aberrometry
Time frame: One three, six and twelve months
Questionnaire Measuring Patient Preference for Laser Device
Time frame: Intraoperative (Approximately 1 minute after completion of surgery)
Patient Reported Outcomes With LASIK
Time frame: One month, three months, six months and twelve months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Manche, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intralase IFS150 and Visumax in people with Myopia and Astigmatism, run by Edward E. Manche at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ETDRS Uncorrected Visual Acuity (time frame: At post-operative month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.