HealthyNCT00863876
Comparison of WaveLight Analyzer and Alcon LadarWave
An observational study of Healthy and Keratoconus, run by WaveLight AG at 1 site in Germany.
Trial summary
Comparison of repeated WaveLight Analyzer and Alcon LadarWave measurements in phakic and pseudophakic eyes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Keratoconus
- How many people
- 144 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to not given
- Phase
- Observational
- 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
Study population: healthy patients and patients following surgery, patients with keratoconus presenting for examination at the clinic
Who may be able to join
- healthy eyes or eyes with the study conditions
Who cannot join
- age < 18, eye disorders other than mentioned above, participation in any other study,
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Heidelberg, Dept. of Ophthalmology
Heidelberg, 69120
About this study
Comparison of repeated WaveLight Analyzer and Alcon LadarWave measurements in phakic and pseudophakic eyes.
- Conditions
- Healthy, Keratoconus
- Keywords
- wavefront measurements of the entire eye
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | non-operated healthy eyes | |
| 2 | eyes 1 months following LASIK | |
| 3 | eyes 3-6 months following LASIK | |
| 4 | eyes with spherical monofocal IOLs more than 3 months postop | |
| 5 | eyes with aspherical monofocal IOLs more than 3 months postop | |
| 6 | eyes with toric monofocal IOLs more than 3 months postop | |
| 7 | eyes with diffractive multifocal IOLs more than 3 months postop | |
| 8 | eyes with phakic IOLs more than 3 months postop | |
| 9 | eyes with keratoconus |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WaveLight AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863876
- Sponsor's protocol ID
- S-388/2008
- Status last verified
- Jun 2010
- First submitted
- 17 Mar 2009
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of WaveLight Analyzer and Alcon LadarWave
- ClinicalTrials.gov ID
- NCT00863876
- Acronym / sponsor ID
- S-388/2008
- Conditions
- Healthy, Keratoconus
- Keywords
- wavefront measurements of the entire eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- WaveLight AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- First posted
- 18 Mar 2009 (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.
Comparison of repeated WaveLight Analyzer and Alcon LadarWave measurements in phakic and pseudophakic eyes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –non-operated healthy eyes |
| 2 | – | –eyes 1 months following LASIK |
| 3 | – | –eyes 3-6 months following LASIK |
| 4 | – | –eyes with spherical monofocal IOLs more than 3 months postop |
| 5 | – | –eyes with aspherical monofocal IOLs more than 3 months postop |
| 6 | – | –eyes with toric monofocal IOLs more than 3 months postop |
| 7 | – | –eyes with diffractive multifocal IOLs more than 3 months postop |
| 8 | – | –eyes with phakic IOLs more than 3 months postop |
| 9 | – | –eyes with keratoconus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy patients and patients following surgery, patients with keratoconus presenting for examination at the clinic
Key inclusion criteria (1 listed)
- healthy eyes or eyes with the study conditions
Key exclusion criteria (1 listed)
- age < 18, eye disorders other than mentioned above, participation in any other study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 29 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Keratoconus, run by WaveLight AG at 1 site in Germany.
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 1 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 29 Jun 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 Germany. 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.
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 29 Jun 2010.