KeratoconusNCT00584285
Corneal Topographer Fluorescein Patterns
An observational study of Keratoconus, run by Christine Sindt at 1 site in United States.
Trial summary
The objective of this study is to determine if corneal topography can be used to predict the fluorescein pattern of keratoconus lenses on the eye. A corneal topography image will be taken and the computer selected lens will be placed on the eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2007to 14 Sep 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: 18 yrs of age or older with diagnosis of keratoconus and contact lens wearer
Who may be able to join
- 18 yrs of age or older with diagnosis of keratoconus and contact lens wearer
Who cannot join
- Noncommittant corneal disease or surgery Inability to capture topography measurement
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics - Dept. of Ophthalmology
Iowa City, Iowa, 52242
About this study
Official title: Objective and Subjective Correlation Between Clinical Fluorescein Patterns and Theoretical Patterns Using the Medmont Corneal Topographer
The objective of this study is to determine if corneal topography can be used to predict the fluorescein pattern of keratoconus lenses on the eye. A corneal topography image will be taken and the computer selected lens will be placed on the eye. After placement of the lens color photographs will be taken of the eye's fluorescein pattern and compared to the computer predicted pattern.
Read the detailed description
Subject population: keratoconus patients who have not undergone corneal surgery 100 subjects who come to UIHC for their contact lens care. We will approach them at their visit. We will not call potential participants from a database.
If topography is impossible to capture. Concommitant Corneal Disease Minors will be excluded
- Conditions
- Keratoconus
- 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 |
|---|---|---|
| Corneal Topographer Fluorescein Patterns | Use corneal topography to evaluate fluorescein pattern of rgp contact lens. Used corneal topography to develop theoretical fluorescein patters on a virtual eye. Theoretical lens developed by the topographer was ordered to compare to the actual fluorescein pattern on the actual eye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Observable Difference Between Virtual Versus Actual Fluorescein Patterns
Comparison of fluorescein patterns of rgp contact lens. Bearing and elevation fluorescein patterns will be compared between the actual (photo) and theoretical (computer generated) fluorescein patterns using standard clinical means.
Measured: Baseline first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study start15 Sep 2007
- Primary completion4 Sep 2009
- Study completion14 Sep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christine Sindt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christine Sindt, University of Iowa
- Investigators
- Christine W. Sindt, OD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584285
- Sponsor's protocol ID
- 200709737
- Status last verified
- Mar 2018
- First submitted
- 21 Dec 2007
- Last updated
- 2 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szczotka LB. Clinical evaluation of a topographically based contact lens fitting software. Optom Vis Sci. 1997 Jan;74(1):14-9. doi: 10.1097/00006324-199701000-00015.
PubMed 9148262Jani BR, Szczotka LB. Efficiency and accuracy of two computerized topography software systems for fitting rigid gas permeable contact lenses. CLAO J. 2000 Apr;26(2):91-6.
PubMed 10810939Rabinowitz YS, Garbus JJ, Garbus C, McDonnell PJ. Contact lens selection for keratoconus using a computer-assisted videophotokeratoscope. CLAO J. 1991 Apr;17(2):88-93.
PubMed 2049828Szczotka LB. Corneal topography and contact lenses. Ophthalmol Clin North Am. 2003 Sep;16(3):433-53. doi: 10.1016/s0896-1549(03)00054-3.
PubMed 14564765Bufidis T, Konstas AG, Mamtziou E. The role of computerized corneal topography in rigid gas permeable contact lens fitting. CLAO J. 1998 Oct;24(4):206-9.
PubMed 9800058
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective and Subjective Correlation Between Clinical Fluorescein Patterns and Theoretical Patterns Using the Medmont Corneal Topographer
- ClinicalTrials.gov ID
- NCT00584285
- Acronym / sponsor ID
- 200709737
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Christine SindtUniversity, hospital or other
- Study start
- 15 Sep 2007 (actual)
- Primary completion
- 4 Sep 2009 (actual)
- Study completion
- 14 Sep 2009 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Posted 2 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine if corneal topography can be used to predict the fluorescein pattern of keratoconus lenses on the eye. A corneal topography image will be taken and the computer selected lens will be placed on the eye. After placement of the lens color photographs will be taken of the eye's fluorescein pattern and compared to the computer predicted pattern.
Detailed description
Subject population: keratoconus patients who have not undergone corneal surgery 100 subjects who come to UIHC for their contact lens care. We will approach them at their visit. We will not call potential participants from a database.
If topography is impossible to capture. Concommitant Corneal Disease Minors will be excluded
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corneal Topographer Fluorescein Patterns | – | –Use corneal topography to evaluate fluorescein pattern of rgp contact lens. Used corneal topography to develop theoretical fluorescein patters on a virtual eye. Theoretical lens developed by the topographer was ordered to compare to the actual fluorescein pattern on the actual eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 yrs of age or older with diagnosis of keratoconus and contact lens wearer
Key inclusion criteria (1 listed)
- 18 yrs of age or older with diagnosis of keratoconus and contact lens wearer
Key exclusion criteria (1 listed)
- Noncommittant corneal disease or surgery Inability to capture topography measurement
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
Number of Participants With an Observable Difference Between Virtual Versus Actual Fluorescein Patterns
Time frame: Baseline first visit
Comparison of fluorescein patterns of rgp contact lens. Bearing and elevation fluorescein patterns will be compared between the actual (photo) and theoretical (computer generated) fluorescein patterns using standard clinical means.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9148262Szczotka LB. Clinical evaluation of a topographically based contact lens fitting software. Optom Vis Sci. 1997 Jan;74(1):14-9. doi: 10.1097/00006324-199701000-00015.
- Background: PubMed 10810939Jani BR, Szczotka LB. Efficiency and accuracy of two computerized topography software systems for fitting rigid gas permeable contact lenses. CLAO J. 2000 Apr;26(2):91-6.
- Background: PubMed 2049828Rabinowitz YS, Garbus JJ, Garbus C, McDonnell PJ. Contact lens selection for keratoconus using a computer-assisted videophotokeratoscope. CLAO J. 1991 Apr;17(2):88-93.
- Background: PubMed 14564765Szczotka LB. Corneal topography and contact lenses. Ophthalmol Clin North Am. 2003 Sep;16(3):433-53. doi: 10.1016/s0896-1549(03)00054-3.
- Background: PubMed 9800058Bufidis T, Konstas AG, Mamtziou E. The role of computerized corneal topography in rigid gas permeable contact lens fitting. CLAO J. 1998 Oct;24(4):206-9.
- Individual participant dataSharing planned: No
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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.
Christine W. Sindt, OD principal investigator
University of Iowa
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 Keratoconus, run by Christine Sindt 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 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 2 Nov 2018. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With an Observable Difference Between Virtual Versus Actual Fluorescein Patterns (time frame: Baseline first visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00584285, which also lists 5 linked publications.
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 2 Nov 2018.