MyopiaNCT00412295
Evaluation of Alcon Ladarvision Wavefront-Guided PRK
A study testing Alcon Ladarvision (Wavefront-guided PRK) in people with Myopia, run by Walter Reed Army Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to: 1. determine the safety of wavefront guided PRK 2. evaluate the efficacy of wavefront guided PRK 3. evaluate the differences in visual quality after treatment of wavefront guided PRK Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Alcon Ladarvision (Wavefront-guided PRK)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- 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
- Subjects will be recruited from those active duty soldiers that have requested refractive surgery. Subjects must be eligible for medical care at WRAMC.
- Male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- Manifest refractive spherical equivalent (MSE) of up to -6 diopters (D) at the spectacle plane with refractive cylinder up to 3.00D.
- At least five images must be capturesd in both eyes (dilated) with a pupil size of at least 7mm.
- Manifest refraction and LADARWave™ refractions must be within 1.00 D and the CustomCornea® software must allow for treatment with a 6.5mm minor axis and 9mm ablation zone.
- Best spectacle corrected visual acuity of 20/20 or better in both eyes.
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- Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50D during the 12-month period immediately preceding the baseline examination, sa confirmed by clinical records.
- Soft contact lens users must have removed their lenses at least 2 weeks before baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least 4 weeks prior to baseline measurements adn have 2 central Keratometry readings and 2 manifest refractions taken at least 1 week apart that do not differ by more than 0.50D in either meridian; mires should be regular.
- Located it the greater Washington DC Area for a 12-month period.
- Exhibits strong motivation for attending the follow-up visits.
- Consent of the subject's command (active duty) to participate in the study.
- 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.
- Concurrent topical or systemic medications that may impair healing, including corticosteriods, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin.
- Medical condition(s), which, in the judgement of the investigator, may impair healing, including but not limited to: collagen vascular diseases and ocular herpes zoster or simplex.
- 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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- History of recurrent erosions or epithelial baewsment dystrophy.
- Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- Any physical or mental impairment that would preclude participation in any of the examinations.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Naval Medical Center
San Diego, California, 92134
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:
- determine the safety of wavefront guided PRK
- evaluate the efficacy of wavefront guided PRK
- evaluate the differences in visual quality after treatment of wavefront guided PRK
- Conditions
- Myopia
- Being tested
- Alcon Ladarvision (Wavefront-guided PRK)
- Keywords
- Naturally occuring myopia with or without astigmatism., Wavefront errors
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcon Ladarvision (Wavefront-guided PRK)Device
Wavefront-guided PRK using Alcon Ladarvision
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Wavefront-guided PRK Receives: Device: Alcon Ladarvision (Wavefront-guided PRK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected distance visual acuity (CDVA)
CDVA (logMAR unit and/or snellen equivalent) will be measured to determine safety of wavefront guided PRK.
Measured: 12 months
Uncorrected distance visual acuity (UDVA)
UDVA (logMAR unit and/or snellen equivalent) will be measured to determine effectiveness of wavefront guided PRK.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
Why it stopped: Lack of resources and not because of any concern with the safety or effectiveness of the procedures studied.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Samantha B. Rodgers, MD, Walter Reed Army Medical Center
- Investigators
- STEVEN SCHALLHORN, MD, Principal investigator, United States Naval Medical Center, San DiegoKRAIG S BOWER, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412295
- Sponsor's protocol ID
- WRAMC WU#04-23006
- Status last verified
- Dec 2014
- First submitted
- 15 Dec 2006
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Alcon Ladarvision Wavefront-Guided PRK
- ClinicalTrials.gov ID
- NCT00412295
- Acronym / sponsor ID
- WRAMC WU#04-23006
- Conditions
- Myopia
- Keywords
- Naturally occuring myopia with or without astigmatism., Wavefront errors
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of resources and not because of any concern with the safety or effectiveness of the procedures studied.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- First posted
- 18 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:
- determine the safety of wavefront guided PRK
- evaluate the efficacy of wavefront guided PRK
- evaluate the differences in visual quality after treatment of wavefront guided PRK
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Alcon Ladarvision (Wavefront-guided PRK)Wavefront-guided PRK |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects will be recruited from those active duty soldiers that have requested refractive surgery. Subjects must be eligible for medical care at WRAMC.
- Male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- Manifest refractive spherical equivalent (MSE) of up to -6 diopters (D) at the spectacle plane with refractive cylinder up to 3.00D.
- At least five images must be capturesd in both eyes (dilated) with a pupil size of at least 7mm.
- Manifest refraction and LADARWave™ refractions must be within 1.00 D and the CustomCornea® software must allow for treatment with a 6.5mm minor axis and 9mm ablation zone.
Key exclusion criteria (9 listed)
- Female subjects who are pregnant, breast feeding or intend to become pregnant during the study.
- Concurrent topical or systemic medications that may impair healing, including corticosteriods, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin.
- Medical condition(s), which, in the judgement of the investigator, may impair healing, including but not limited to: collagen vascular diseases and ocular herpes zoster or simplex.
- 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 |
|---|---|---|
| Alcon Ladarvision (Wavefront-guided PRK)Wavefront-guided PRK using Alcon Ladarvision | Device | Treatment |
Primary outcome
Corrected distance visual acuity (CDVA)
Time frame: 12 months
CDVA (logMAR unit and/or snellen equivalent) will be measured to determine safety of wavefront guided PRK.
Uncorrected distance visual acuity (UDVA)
Time frame: 12 months
UDVA (logMAR unit and/or snellen equivalent) will be measured to determine effectiveness of wavefront guided PRK.
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 23 Jul 2025.
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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.
STEVEN SCHALLHORN, MD principal investigator
United States Naval Medical Center, San Diego
KRAIG S BOWER, MD principal investigator
Walter Reed Army Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcon Ladarvision (Wavefront-guided PRK) in people with Myopia, run by Walter Reed Army Medical Center at 2 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 12 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: withdrawn, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Corrected distance visual acuity (CDVA) (time frame: 12 months). 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 23 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.