Refractive ErrorNCT01827748
Evaluation of a Surgical Microscope Mounted Autorefractor When Used on Patients Lying in a Supine Position
A study testing Intraoperative Autorefractor IAR-1 and Hartmann-Shack Auto Refractor in people with Refractive Error, run by Adventus Technology at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the accuracy and repeatability of an individually validated prototype autorefractor designed to be mounted on a surgical microscope. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Error
- What is being tested?
- Intraoperative Autorefractor IAR-1 and Hartmann-Shack Auto Refractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age as of the date of evaluation for the study.
- Have:
- Read the Informed Consent
- been given an explanation of the Informed Consent
- indicated understanding of the Informed Consent
- signed the Informed Consent document.
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- Be willing and able to adhere to the instructions set forth in this protocol and able to participate in all scheduled evaluations.
- Be in good general health, based on his/her knowledge.
- Have a refractive error within the range of -10.00 to +30.00 Diopter sphere and up to 5.00 Diopter of refractive cylinder .
- Have manifest refraction (BCVA) Snellen visual acuities (VA) equal to or better than 20/25 in each eye. -
Who cannot join
- Subjects may not be enrolled in this study if any of the following apply: The subject is/has:
- Allergy to Tropicamide or a previous adverse reaction to Tropicamide.
- Poor personal hygiene as observed by the investigational site personnel.
- Strabismus
- Currently pregnant (to the best of the subject's knowledge) or is lactating.
- Previous refractive surgery or current or previous orthokeratology treatment.
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- Aphakic or pseudophakic or has cataracts that interfere with visual acuity.
- Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.
- The need for topical ocular medications or any medication which might interfere with the study evaluations.
- The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
- Slit lamp findings, including but not limited to:
- Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2 Pterygium Corneal scars within the visual axis Neovascularization or ghost vessels > 1.0 mm in from the limbus Giant papillary conjunctivitis (GPC) of > Grade 2 Anterior uveitis or iritis Seborrheic eczema, seborrheic conjunctivitis or blepharitis
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the accuracy and repeatability of an individually validated prototype autorefractor designed to be mounted on a surgical microscope.
Read the detailed description
The purpose of this study is to evaluate the accuracy and repeatability of an individually validated prototype autorefractor designed to be mounted on a surgical microscope. The goal is to evaluate 20 subjects with both the investigational instrument followed by a commercially available instrument.
- Conditions
- Refractive Error
- Being tested
- Intraoperative Autorefractor IAR-1, Hartmann-Shack Auto Refractor
- Keywords
- Autorefractor
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Autorefractor IAR-1Device
This is an auto-refractor mounted on an operating microscope and used with the subject in a supine position
Hartmann-Shack Auto RefractorDevice
Standard auto-refractor used with subject sitting upright in front of the instrument.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Autorefractor IAR-1 | Experimental | This is a auto refractor mounted on an operating microscope. Receives: Device: Intraoperative Autorefractor IAR-1 |
| Hartmann-Shack Auto Refractor | Active comparator | The Hartmann-Shack type auto refractor used with the subject sitting upright in front of the instrument. Receives: Device: Hartmann-Shack Auto Refractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the accuracy and repeatability of the Test device compared to the Control
Comparative auto refractor device measurement variation is defined as +/-0.25 Diopters
Measured: 1 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adventus Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregg Berdy, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827748
- Sponsor's protocol ID
- FA120928
- Status last verified
- Apr 2013
- First submitted
- 29 Mar 2013
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Surgical Microscope Mounted Autorefractor When Used on Patients Lying in a Supine Position
- ClinicalTrials.gov ID
- NCT01827748
- Acronym / sponsor ID
- FA120928
- Conditions
- Refractive Error
- Keywords
- Autorefractor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Adventus TechnologyIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 10 Apr 2013 (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 the accuracy and repeatability of an individually validated prototype autorefractor designed to be mounted on a surgical microscope.
Detailed description
The purpose of this study is to evaluate the accuracy and repeatability of an individually validated prototype autorefractor designed to be mounted on a surgical microscope. The goal is to evaluate 20 subjects with both the investigational instrument followed by a commercially available instrument.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Autorefractor IAR-1 | Experimental | Device: Intraoperative Autorefractor IAR-1This is a auto refractor mounted on an operating microscope. |
| Hartmann-Shack Auto Refractor | Active comparator | Device: Hartmann-Shack Auto RefractorThe Hartmann-Shack type auto refractor used with the subject sitting upright in front of the instrument. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be at least 18 years of age as of the date of evaluation for the study.
- Have:
- Be willing and able to adhere to the instructions set forth in this protocol and able to participate in all scheduled evaluations.
- Be in good general health, based on his/her knowledge.
- Have a refractive error within the range of -10.00 to +30.00 Diopter sphere and up to 5.00 Diopter of refractive cylinder .
Key exclusion criteria (13 listed)
- Subjects may not be enrolled in this study if any of the following apply: The subject is/has:
- Allergy to Tropicamide or a previous adverse reaction to Tropicamide.
- Poor personal hygiene as observed by the investigational site personnel.
- Strabismus
- Currently pregnant (to the best of the subject's knowledge) or is lactating.
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 |
|---|---|---|
| Intraoperative Autorefractor IAR-1This is an auto-refractor mounted on an operating microscope and used with the subject in a supine position | Device | Intraoperative Autorefractor IAR-1 |
| Hartmann-Shack Auto RefractorStandard auto-refractor used with subject sitting upright in front of the instrument. | Device | Hartmann-Shack Auto Refractor |
Primary outcome
Assessment of the accuracy and repeatability of the Test device compared to the Control
Time frame: 1 Hour
Comparative auto refractor device measurement variation is defined as +/-0.25 Diopters
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 12 Apr 2013.
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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.
Gregg Berdy, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Autorefractor IAR-1 and Hartmann-Shack Auto Refractor in people with Refractive Error, run by Adventus Technology 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 10 inclusion and 13 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 12 Apr 2013. 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?
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?
Assessment of the accuracy and repeatability of the Test device compared to the Control (time frame: 1 Hour). 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 12 Apr 2013.