KeratoconusVOPTICANCT01295164
Measurement of High Order Aberrations in Late Stages Keratoconus
A study testing classic aberrometer and aberrometer AOVIS-1 and Aberrometer AOVIS-I in people with Keratoconus, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The instrument that will be used in the study is the Murcia monocular Adaptive Optics Visual simulator (AOVIS-I). The system provides an objective characterization of the optical quality of the patient's eye by application of wave-front sensing technology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- classic aberrometer and aberrometer AOVIS-1 and Aberrometer AOVIS-I
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Nov 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- to be able to understand an information and give a consent
- patients over 18
- patients with keratoconus
- affiliated to medical insurance.
Who cannot join
- non keratoconus patients
- patients under 18
- pregnant women or nursing mothers
- ocular surgery 90 days before inclusion
- ocular infection
- keratitis
- restless patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Measurement of High Order Aberrations in Late Stages Keratoconus by Using an Adaptive Optics Visual Simulator AOVIS-I
The instrument that will be used in the study is the Murcia monocular Adaptive Optics Visual simulator (AOVIS-I). The system provides an objective characterization of the optical quality of the patient's eye by application of wave-front sensing technology. The optical condition of every eye is represented by its wave aberration. This characterization overcomes the current description based only in refractive errors. This provides an accurate description of the optics of the eye based on the assessment of the whole set of ocular aberrations. The particular wave-front sensor is of a Hartmann-Shack type. One characteristics of this wave-front sensor is its high dynamic range allowing measuring highly aberrated eyes, such as patients with keratoconus.
Read the detailed description
The complete procedure in one patient takes less than 5 minutes and is completely non-invasive.
- Conditions
- Keratoconus
- Being tested
- classic aberrometer and aberrometer AOVIS-1, Aberrometer AOVIS-I
- Keywords
- keratoconus, wave-front sensing technology, aberrometer
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classic aberrometer and aberrometer AOVIS-1Device
Measurement of aberrations in early stages (1 and 2) of keratoconus as compared aberrometer AOVIS-1 with a "classic aberrometer".
Aberrometer AOVIS-IDevice
Measurement of aberrations in high stages (3 and 4) of keratoconus. Objective characterization of the optical quality of the patient eye by application of wave-front sensing technology in late stage keratoconus The complete procedure in one patient takes less than 5 minutes in only one consultation and is completely non invasive. The optical measurements only involve the use of low power infrared laser
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Measurement of aberrations in patients with keratoconus of grade 1 Receives: Device: classic aberrometer and aberrometer AOVIS-1 |
| Group 2 | Active comparator | patients with keratoconus of grade 2 Receives: Device: classic aberrometer and aberrometer AOVIS-1 |
| Group 3 | Experimental | patients with keratoconus of grade 3 Receives: Device: Aberrometer AOVIS-I |
| Group 4 | Experimental | patients with keratoconus of grade 4 Receives: Device: Aberrometer AOVIS-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study is to evaluate the AOVIS-I and its wave-front sensor with high dynamic range for measuring high-order aberrations in patients with late stages (3 and 4) of keratoconus
Measured: at the 1st day
Secondary outcomes (2)
To evaluate the reliability of the measures in early stages (1 and 2) of keratoconus as compared with a "classic aberrometer".
Measured: at the 1st day
To describe the measures obtained in advanced stages (3 and 4) of keratoconus.
Measured: at the 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Malecaze, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295164
- Sponsor's protocol ID
- 10 214 03
- Acronym
- VOPTICA
- Status last verified
- Mar 2017
- First submitted
- 9 Feb 2011
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Measurement of High Order Aberrations in Late Stages Keratoconus by Using an Adaptive Optics Visual Simulator AOVIS-I
- ClinicalTrials.gov ID
- NCT01295164
- Acronym / sponsor ID
- VOPTICA / 10 214 03
- Conditions
- Keratoconus
- Keywords
- keratoconus, wave-front sensing technology, aberrometer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 Feb 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.
The instrument that will be used in the study is the Murcia monocular Adaptive Optics Visual simulator (AOVIS-I). The system provides an objective characterization of the optical quality of the patient's eye by application of wave-front sensing technology. The optical condition of every eye is represented by its wave aberration. This characterization overcomes the current description based only in refractive errors. This provides an accurate description of the optics of the eye based on the assessment of the whole set of ocular aberrations. The particular wave-front sensor is of a Hartmann-Shack type. One characteristics of this wave-front sensor is its high dynamic range allowing measuring highly aberrated eyes, such as patients with keratoconus.
Detailed description
The complete procedure in one patient takes less than 5 minutes and is completely non-invasive.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: classic aberrometer and aberrometer AOVIS-1Measurement of aberrations in patients with keratoconus of grade 1 |
| Group 2 | Active comparator | Device: classic aberrometer and aberrometer AOVIS-1patients with keratoconus of grade 2 |
| Group 3 | Experimental | Device: Aberrometer AOVIS-Ipatients with keratoconus of grade 3 |
| Group 4 | Experimental | Device: Aberrometer AOVIS-Ipatients with keratoconus of grade 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- to be able to understand an information and give a consent
- patients over 18
- patients with keratoconus
- affiliated to medical insurance.
Key exclusion criteria (7 listed)
- non keratoconus patients
- patients under 18
- pregnant women or nursing mothers
- ocular surgery 90 days before inclusion
- ocular infection
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 |
|---|---|---|
| classic aberrometer and aberrometer AOVIS-1Measurement of aberrations in early stages (1 and 2) of keratoconus as compared aberrometer AOVIS-1 with a "classic aberrometer". | Device | Group 1, Group 2 |
| Aberrometer AOVIS-IMeasurement of aberrations in high stages (3 and 4) of keratoconus. Objective characterization of the optical quality of the patient eye by application of wave-front sensing technology in late stage keratoconus The complete procedure in one patient takes less than 5 minutes in only one consultation and is completely non invasive. The optical measurements only involve the use of low power infrared laser | Device | Group 3, Group 4 |
Primary outcome
The primary outcome of the study is to evaluate the AOVIS-I and its wave-front sensor with high dynamic range for measuring high-order aberrations in patients with late stages (3 and 4) of keratoconus
Time frame: at the 1st day
2 secondary outcomes
To evaluate the reliability of the measures in early stages (1 and 2) of keratoconus as compared with a "classic aberrometer".
Time frame: at the 1st day
To describe the measures obtained in advanced stages (3 and 4) of keratoconus.
Time frame: at the 1st day
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- 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.
Francois Malecaze, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing classic aberrometer and aberrometer AOVIS-1 and Aberrometer AOVIS-I in people with Keratoconus, run by University Hospital, Toulouse at 1 site in France.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 3 Mar 2017. 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 France. 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 stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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?
The primary outcome of the study is to evaluate the AOVIS-I and its wave-front sensor with high dynamic range for measuring high-order aberrations in patients with late stages (3 and 4) of keratoconus (time frame: at the 1st day). 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 3 Mar 2017.