Post Laser Vision Correction Pain and DiscomfortNCT01675375
Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain
A study testing Eye Shield in people with Post Laser Vision Correction Pain and Discomfort, run by FORSIGHT Vision3 at 5 sites in United States.
Trial summary
The purpose of this research is to determine if an investigational thin shield can effectively reduce discomfort following Laser Vision Correction. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Laser Vision Correction Pain and Discomfort
- What is being tested?
- Eye Shield
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients scheduled to undergo Laser Vision Correction for correction of refractive error
- FDA approved treatment guidelines for Laser Vision Correction
- Age 18-60
- Patients able to understand the requirements of the study, willing to follow study instructions, provide written informed consent to participate, and comply with all study requirements, including the required study follow-up visits
Who cannot join
- Any other anterior segment abnormality other than that associated with LAser Vision Correction
- Any abnormalities associated with the eye lids
- Uncontrolled blepharitis or dry eye
- Prior laser treatment of the retina
- Any ophthalmic surgery performed within three (3) months prior to study excluding PRK or LASIK
- Diagnosis of glaucoma
Show all 15Show fewer
- Active diabetic retinopathy
- Clinically significant inflammation or infection within six (6) months prior to study
- Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator
- Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational material
- Intolerance or hypersensitivity to topical anesthetics, antibiotics, steroids or any other pharmaceuticals that may be used pre and post surgically
- Specifically known intolerance or hypersensitivity to contact lenses or any component of the investigative material
- A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up
- Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient
- Pregnancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Talamo Laser Eye Consultants
Boston, Massachusetts, 02451
Kraff Eye Institute
Chicago, Illinois, 60602
Physicians Protocol
Greensboro, North Carolina, 27410
ClearView Eye and Laser
San Diego, California, 92121
Vance Thompson Vision
Sioux Falls, South Dakota, 57105
About this study
The purpose of this research is to determine if an investigational thin shield can effectively reduce discomfort following Laser Vision Correction.
- Being tested
- Eye Shield
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye ShieldDevice
one application following refractive surgery
| Study group | Role | What they receive |
|---|---|---|
| Eye shield | Experimental | Eye shield place on post Laser Vision Correction eye Receives: Device: Eye Shield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield
Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield by subjective patient questionnaires and objective imaging and slit lamp examination.
Measured: 1yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Laser Vision Correction Pain and DiscomfortStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- FORSIGHT Vision3
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675375
- Sponsor's protocol ID
- CS 004
- Status last verified
- Feb 2013
- First submitted
- 28 Aug 2012
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain
- ClinicalTrials.gov ID
- NCT01675375
- Acronym / sponsor ID
- CS 004
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- FORSIGHT Vision3Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to determine if an investigational thin shield can effectively reduce discomfort following Laser Vision Correction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eye shield | Experimental | Device: Eye ShieldEye shield place on post Laser Vision Correction eye |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients scheduled to undergo Laser Vision Correction for correction of refractive error
- FDA approved treatment guidelines for Laser Vision Correction
- Age 18-60
- Patients able to understand the requirements of the study, willing to follow study instructions, provide written informed consent to participate, and comply with all study requirements, including the required study follow-up visits
Key exclusion criteria (15 listed)
- Any other anterior segment abnormality other than that associated with LAser Vision Correction
- Any abnormalities associated with the eye lids
- Uncontrolled blepharitis or dry eye
- Prior laser treatment of the retina
- Any ophthalmic surgery performed within three (3) months prior to study excluding PRK or LASIK
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 |
|---|---|---|
| Eye Shieldone application following refractive surgery | Device | Eye shield |
Primary outcome
Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield
Time frame: 1yr
Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield by subjective patient questionnaires and objective imaging and slit lamp examination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Shield in people with Post Laser Vision Correction Pain and Discomfort, run by FORSIGHT Vision3 at 5 sites 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 4 inclusion and 15 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 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evidence of maintaining vision and mitigating pain post Laser Vision Correction using an Eye Shield (time frame: 1yr). 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 5 Feb 2013.