Normal CorneaNCT01220193
Evaluation of RTVue in Corneal Measurement
An observational study of Normal Cornea and Post Laser Refractive Surgery, run by Optovue at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate RTVue measurement of the cornea in various ocular conditions to include normal, pathology, post refractive surgery and cataract. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Cornea, Post Laser Refractive Surgery, Cornea Pathology
- How many people
- 196 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to Dec 2010
- 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: Various ocular conditions to include normal, pathology, post refractive surgery and cataract.
Who may be able to join
- Normal cornea:
- 18 years of age or older
- No corneal pathology
- No prior ocular surgery and no prior laser refractive surgery
- Post laser refractive surgery:
- 18 years of age or older
Show all 18Show fewer
- No corneal pathology
- No prior ocular surgery except laser refractive surgery
- At least 1 week post laser refractive surgery without complication
- Corneal pathology:
- 18 years of age or older
- Clinical diagnosis of one or more type of corneal pathologies, including corneal scar and keratoconus, etc., excluding eyes in which corneal power measurement are not clinically relevant (e.g., eyes requiring corneal transplant)
- No prior laser refractive surgery
- Cataract surgery:
- 18 years of age or older
- No corneal pathology
- No prior ocular surgery, no prior laser refractive surgery, and no prior cataract surgery
- Post surgery visit shall only include eyes without complication
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brass Eye Center
Latham, New York, 12110
Gordon Binder & Weiss Vision Institute
San Diego, California, 92122
About this study
The purpose of this study is to evaluate RTVue measurement of the cornea in various ocular conditions to include normal, pathology, post refractive surgery and cataract.
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 |
|---|---|---|
| Normal cornea | Not described | |
| Post laser refractive surgery | Not described | |
| Cornea pathology | Not described | |
| Cataract surgery | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startApr 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal CorneaStudies 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
- Prospective
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optovue
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220193
- Sponsor's protocol ID
- RTVue 100 - 2009
- Status last verified
- Feb 2011
- First submitted
- 11 Oct 2010
- Last updated
- 18 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of RTVue in Corneal Measurement
- ClinicalTrials.gov ID
- NCT01220193
- Acronym / sponsor ID
- RTVue 100 - 2009
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- OptovueIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Oct 2010 (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 evaluate RTVue measurement of the cornea in various ocular conditions to include normal, pathology, post refractive surgery and cataract.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal cornea | – | – |
| Post laser refractive surgery | – | – |
| Cornea pathology | – | – |
| Cataract surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Various ocular conditions to include normal, pathology, post refractive surgery and cataract.
Key inclusion criteria (18 listed)
- 18 years of age or older
- No corneal pathology
- No prior ocular surgery and no prior laser refractive surgery
- 18 years of age or older
- No corneal pathology
Key exclusion criteria (0 listed)
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 18 Feb 2011.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Cornea and Post Laser Refractive Surgery, run by Optovue 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 18 inclusion and 0 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 18 Feb 2011. 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 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 18 Feb 2011.