KeratitisNCT01272271
Safety of Overnight Corneal Reshaping Lenses
An observational study of Keratitis and Myopia, run by Ohio State University.
Trial summary
This retrospective chart review study compares the incidence of corneal inflammation due to infection in children vs. adult patients wearing overnight corneal reshaping lenses. Read more about this study
- Who is it for?
- Ages 5 to 69 yearsHealthy volunteers can take part
- How many people
- 1,317 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Oct 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 5 to 69 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Randomized sample of optometry and ophthalmology patients seen by 200 practitioners in various practice settings, stratified on manufacturer, practitioner volume.
Who may be able to join
- Patients completing at least 3 months of wearing corneal reshaping lenses
Who cannot join
- Less than 3 months of wearing corneal reshaping lenses
About this study
Official title: Postmarket Study of the Safety of Overnight Corneal Reshaping Lenses
This retrospective chart review study compares the incidence of corneal inflammation due to infection in children vs. adult patients wearing overnight corneal reshaping lenses.
- Keywords
- Contact lens, Infection, Cornea
- Medical subject headings
- Keratitis, Myopia, Infections, Corneal Diseases
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 |
|---|---|---|
| Children | Not described | |
| Adults | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial keratitis incidence
Incidence of microbial keratitis in children vs. adults with the use of two brands of corneal reshaping lenses.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startFeb 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratitisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 1,317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated, CooperVision, Inc.
- Investigators
- Mark A Bullimore, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272271
- Sponsor's protocol ID
- 2007H0273
- Status last verified
- Apr 2024
- First submitted
- 6 Jan 2011
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarket Study of the Safety of Overnight Corneal Reshaping Lenses
- ClinicalTrials.gov ID
- NCT01272271
- Acronym / sponsor ID
- 2007H0273
- Keywords
- Contact lens, Infection, Cornea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,317 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated, CooperVision, Inc.
- Study start
- Feb 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 Jan 2011 (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.
This retrospective chart review study compares the incidence of corneal inflammation due to infection in children vs. adult patients wearing overnight corneal reshaping lenses.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | – |
| Adults | – | – |
Who may qualify
- Ages
- 5 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Randomized sample of optometry and ophthalmology patients seen by 200 practitioners in various practice settings, stratified on manufacturer, practitioner volume.
Key inclusion criteria (1 listed)
- Patients completing at least 3 months of wearing corneal reshaping lenses
Key exclusion criteria (1 listed)
- Less than 3 months of wearing corneal reshaping lenses
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
Microbial keratitis incidence
Time frame: 1 year
Incidence of microbial keratitis in children vs. adults with the use of two brands of corneal reshaping lenses.
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 Apr 2024.
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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.
Mark A Bullimore, PhD principal investigator
Ohio State University
Questions about this trial
What is this clinical trial studying?
An observational study of Keratitis and Myopia, run by Ohio State University.
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 Apr 2024. 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.
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?
Microbial keratitis incidence (time frame: 1 year). 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 29 Apr 2024.