MyopiaPhase 4NCT01706237
Visual Outcomes And Contrast Sensitivity After Myopic Wavefront-Optimized Lasik With Nexisvision Shield Or Bandage Contact Lens
A Phase 4 study testing Nexisvision shield in people with Myopia, run by Durrie Vision.
Trial summary
Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic LASIK with a Nexisvision Shield or bandage contact lens placed postoperatively. Early speed of visual recovery results indicate that the visual recovery in the first 4 hours after the LASIK procedure show the most variability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Nexisvision shield
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Jun 2014
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female in good general health, 18 years of age or older at the time of the pre-operative examination
- Patient must be able to read, comprehend and willing to give HIPPA and informed consent
- Patient is planning to undergo a bilateral LASIK procedure
- Both eyes must have a manifest refractive error from -1.00 D to -7.00 spherical equivalent with less than or equal to 3.00D of refractive astigmatism as expressed in spectacle minus cylinder form
- Both eyes must have a BSCVA of 20/20 or better
- Both eyes must demonstrate refractive stability confirmed by clinical records, previous glasses, or investigator's discretion.
- Patient must be willing to comply with study dosing and complete the entire course of the study.
Who cannot join
- A patient with evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye
- A patient seeking monovision
- A patient with a known hypersensitivity to any of the components of the procedural or post-LASIK medications
- A patient requiring the use of any ocular drop(s) and/or medication(s) in either eye during the study period with the exception of ocular drops and/or medications provided by the investigator
- A patient having any surgical procedure within a week preceding the scheduled LASIK surgery
- A patient with any UNCONTROLLED systemic disease (i.e., a potential patient in whom therapy for a systemic disease is not yet stabilized )
Show all 10Show fewer
- A patient with a history of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring), or evidence of glaucoma or propensity for narrow angle glaucoma in either eye
- A patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results
- A patient with a history of any of the following medical conditions, or any other condition that could affect wound healing: uncontrolled diabetes, collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
About this study
Official title: Evaluation Of Visual Outcomes And Contrast Sensitivity After Myopic Wavefront-Optimized Lasik With Nexisvision Shield Or Bandage Contact Lens
Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic LASIK with a Nexisvision Shield or bandage contact lens placed postoperatively. Early speed of visual recovery results indicate that the visual recovery in the first 4 hours after the LASIK procedure show the most variability. A patient's ability to drive after their LASIK procedure would potentially alleviate a challenge that patients often face in taking additional time off work or simply finding a ride to there LASIK procedure.
Read the detailed description
Laser in situ keratomileusis (LASIK) surgery has been performed worldwide since 1990. Historically, LASIK has been reported to decrease contrast sensitivity post operatively and patients have been advised to take the day off of work and potentially the day after LASIK. More recently, utilizing advanced laser technology for optimized corneal ablation and creation of the flap has the potential for improved LASIK surgery results and improved recovery time. Visual recovery and management of immediate post operative visual acuity is important for patient satisfaction.
- Conditions
- Myopia
- Being tested
- Nexisvision shield
- Keywords
- Myopia, LASIK
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexisvision shieldDevice
A shield is placed on the eye after LASIK. The shield is similar to a contact lens.
| Study group | Role | What they receive |
|---|---|---|
| Shield | Experimental | A shield (similar to a contact lens) is placed on the eye after myopic LASIK procedure. Receives: Device: Nexisvision shield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity over time
Progress of the change in visual acuity will be measured at specific time intervals directly after LASIK surgery.
Measured: Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours
Contrast Sensitivity
Change in contrast sensitivity compared to baseline will be documented at specific time intervals beginning immediately after LASIK surgery.
Measured: Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2014
Why it stopped: Nexis Vision was unable to provide the shields to continue with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durrie Vision
- Sponsor type
- University, hospital or other
- Collaborators
- Nexisvision
- Responsible party
- Sponsor
- Investigators
- Daniel S Durrie, MD, Principal investigator, Durrie VisionStephen G. Slade, MD, Principal investigator, Slade & Baker Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706237
- Sponsor's protocol ID
- NVS-SOVR-001
- Status last verified
- Jun 2014
- First submitted
- 11 Oct 2012
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Visual Outcomes And Contrast Sensitivity After Myopic Wavefront-Optimized Lasik With Nexisvision Shield Or Bandage Contact Lens
- ClinicalTrials.gov ID
- NCT01706237
- Acronym / sponsor ID
- NVS-SOVR-001
- Conditions
- Myopia
- Keywords
- Myopia, LASIK
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Nexis Vision was unable to provide the shields to continue with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Durrie VisionUniversity, hospital or other
- Collaborators
- Nexisvision
- Study start
- May 2012
- Primary completion
- Jun 2014 (actual)
- First posted
- 15 Oct 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.
Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic LASIK with a Nexisvision Shield or bandage contact lens placed postoperatively. Early speed of visual recovery results indicate that the visual recovery in the first 4 hours after the LASIK procedure show the most variability. A patient's ability to drive after their LASIK procedure would potentially alleviate a challenge that patients often face in taking additional time off work or simply finding a ride to there LASIK procedure.
Detailed description
Laser in situ keratomileusis (LASIK) surgery has been performed worldwide since 1990. Historically, LASIK has been reported to decrease contrast sensitivity post operatively and patients have been advised to take the day off of work and potentially the day after LASIK. More recently, utilizing advanced laser technology for optimized corneal ablation and creation of the flap has the potential for improved LASIK surgery results and improved recovery time. Visual recovery and management of immediate post operative visual acuity is important for patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shield | Experimental | Device: Nexisvision shieldA shield (similar to a contact lens) is placed on the eye after myopic LASIK procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female in good general health, 18 years of age or older at the time of the pre-operative examination
- Patient must be able to read, comprehend and willing to give HIPPA and informed consent
- Patient is planning to undergo a bilateral LASIK procedure
- Both eyes must have a manifest refractive error from -1.00 D to -7.00 spherical equivalent with less than or equal to 3.00D of refractive astigmatism as expressed in spectacle minus cylinder form
- Both eyes must have a BSCVA of 20/20 or better
Key exclusion criteria (10 listed)
- A patient with evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye
- A patient seeking monovision
- A patient with a known hypersensitivity to any of the components of the procedural or post-LASIK medications
- A patient requiring the use of any ocular drop(s) and/or medication(s) in either eye during the study period with the exception of ocular drops and/or medications provided by the investigator
- A patient having any surgical procedure within a week preceding the scheduled LASIK surgery
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 |
|---|---|---|
| Nexisvision shieldA shield is placed on the eye after LASIK. The shield is similar to a contact lens. | Device | Shield |
Primary outcome
Visual Acuity over time
Time frame: Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours
Progress of the change in visual acuity will be measured at specific time intervals directly after LASIK surgery.
Contrast Sensitivity
Time frame: Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours
Change in contrast sensitivity compared to baseline will be documented at specific time intervals beginning immediately after LASIK surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
Related trials for Myopia
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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.
Daniel S Durrie, MD principal investigator
Durrie Vision
Stephen G. Slade, MD principal investigator
Slade & Baker Vision
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nexisvision shield in people with Myopia, run by Durrie Vision.
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 7 inclusion and 10 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: withdrawn, as of the sponsor's last update on 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Visual Acuity over time (time frame: Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours). The study lists 2 primary outcomes in all. 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 4 Jun 2014.