Refractive ErrorsNCT00413881
A Prospective Comparison of Alcon LADARVision Wavefront-guided LASIK Enhancement and Conventional LASIK Enhancement for the Correction of Residual Refractive Errors Following LASIK Procedures
A study testing WAVEFRONT- GUIDED LASIK ENHANCEMENT and CONVENTIONAL LASIK ENHANCEMENT in people with Refractive Errors, run by Walter Reed Army Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to conduct a prospective clinical trial to compare conventional and WFG LASIK for enhancements on post-LASIK patients. Differences in safety, efficacy, visual quality, and refractive stability will also be compared during this study. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- WAVEFRONT- GUIDED LASIK ENHANCEMENT and CONVENTIONAL LASIK ENHANCEMENT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Mar 2008
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, of any race, and at least 21 years old at the time of the preoperative exam, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- At least 6 months from original LASIK surgery.
- Stable refraction with more than 0.75D of spherical equivalent from the desired correction and have less than 1.50D of cylinder in the manifest refraction.
- Both eyes must be within 1.00D spherical equivalent of each other on the manifest refraction test.
- The eye to be treated with wavefront-guided enhancement must have at least a 9.5mm flap.
- Manifest refraction and LADARWave™ refractions must be within 1.00D.
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- At least 3 lines potential improvement in UCVA.
- BSCVA of 20/20 or better.
- Good corneal flap and interface.
- Adequate corneal thickness for surgery (residual stromal bed > 280 microns).
- Able and willing to give informed consent.
- Located in the greater Washington DC area for a 12-month period.
- Access to transportation to meet follow-up requirements.
Who cannot join
- Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Pregnancy will be ruled out with a urine pregnancy test.
- Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin, as determined by history.
- Medical condition(s), which, in the judgement of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex (As determined by history).
- Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or clinically significant lens opacity.
- Evidence of glaucoma or an intraocular pressure greater than 22mm Hg at baseline.
- Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
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- Flap irregularity(striae, interface debris, scarring, or epithelium).
- Calculated residual stroma bed less than 280.
- Stable refraction with less than 0.75D of spherical equivalent from the desired correction and more than 1.5D of cylinder in the manifest refraction.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center, Center For Refractive Surgery
Washington D.C., District of Columbia, 20307
About this study
The purpose of this study is to conduct a prospective clinical trial to compare conventional and WFG LASIK for enhancements on post-LASIK patients. Differences in safety, efficacy, visual quality, and refractive stability will also be compared during this study.
- Conditions
- Refractive Errors
- Being tested
- WAVEFRONT- GUIDED LASIK ENHANCEMENT, CONVENTIONAL LASIK ENHANCEMENT
- Keywords
- Residual refractive error left over from initial LASIK correction., Higher Order aberrations measured using a wavefront analyzer.
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAVEFRONT- GUIDED LASIK ENHANCEMENTProcedure or surgery
Laser treatment to correct residual refractive error left over from initial LASIK correction using wavefront guided LADARvision 4000 excimer laser system
CONVENTIONAL LASIK ENHANCEMENTProcedure or surgery
Laser treatment to correct residual refractive error left over from initial LASIK correction using LADARvision 4000 excimer laser system.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Conventional LASIK Enhancement Receives: Procedure: CONVENTIONAL LASIK ENHANCEMENT |
| 1 | Experimental | Wavefront guided LASIK Enhancement Receives: Procedure: WAVEFRONT- GUIDED LASIK ENHANCEMENT |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Safety 2. Efficacy 3. Refractive stability
Measured: one year after enhancement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2006 (estimated)
- Study startJul 2004
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- RICHARD STUTZMAN, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413881
- Sponsor's protocol ID
- WRAMC WU # 04-23011
- Status last verified
- Mar 2008
- First submitted
- 19 Dec 2006
- Last updated
- 14 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Alcon LADARVision Wavefront-guided LASIK Enhancement and Conventional LASIK Enhancement for the Correction of Residual Refractive Errors Following LASIK Procedures
- ClinicalTrials.gov ID
- NCT00413881
- Acronym / sponsor ID
- WRAMC WU # 04-23011
- Conditions
- Refractive Errors
- Keywords
- Residual refractive error left over from initial LASIK correction., Higher Order aberrations measured using a wavefront analyzer.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- Jul 2004
- Study completion
- Mar 2008 (actual)
- First posted
- 20 Dec 2006 (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 study is to conduct a prospective clinical trial to compare conventional and WFG LASIK for enhancements on post-LASIK patients. Differences in safety, efficacy, visual quality, and refractive stability will also be compared during this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Procedure: CONVENTIONAL LASIK ENHANCEMENTConventional LASIK Enhancement |
| 1 | Experimental | Procedure: WAVEFRONT- GUIDED LASIK ENHANCEMENTWavefront guided LASIK Enhancement |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female, of any race, and at least 21 years old at the time of the preoperative exam, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- At least 6 months from original LASIK surgery.
- Stable refraction with more than 0.75D of spherical equivalent from the desired correction and have less than 1.50D of cylinder in the manifest refraction.
- Both eyes must be within 1.00D spherical equivalent of each other on the manifest refraction test.
- The eye to be treated with wavefront-guided enhancement must have at least a 9.5mm flap.
Key exclusion criteria (9 listed)
- Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Pregnancy will be ruled out with a urine pregnancy test.
- Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin, as determined by history.
- Medical condition(s), which, in the judgement of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex (As determined by history).
- Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or clinically significant lens opacity.
- Evidence of glaucoma or an intraocular pressure greater than 22mm Hg at baseline.
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 |
|---|---|---|
| WAVEFRONT- GUIDED LASIK ENHANCEMENTLaser treatment to correct residual refractive error left over from initial LASIK correction using wavefront guided LADARvision 4000 excimer laser system | Procedure or surgery | 1 |
| CONVENTIONAL LASIK ENHANCEMENTLaser treatment to correct residual refractive error left over from initial LASIK correction using LADARvision 4000 excimer laser system. | Procedure or surgery | 2 |
Primary outcome
1.Safety 2. Efficacy 3. Refractive stability
Time frame: one year after enhancement
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 14 Jan 2010.
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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.
RICHARD STUTZMAN, MD principal investigator
Walter Reed Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WAVEFRONT- GUIDED LASIK ENHANCEMENT and CONVENTIONAL LASIK ENHANCEMENT in people with Refractive Errors, run by Walter Reed Army Medical Center 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 13 inclusion and 9 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 Jan 2010. 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?
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?
1.Safety 2. Efficacy 3. Refractive stability (time frame: one year after enhancement). 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 Jan 2010.