Normal Individuals With Visual AberrationsNCT01230164
Comparison of Four Different Aberrometers for Evaluation of Higher Order Visual Aberrations
An observational study of Normal Individuals With Visual Aberrations, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
An aberrometer measures visual aberrations by mapping how light rays travel through the eye and by providing maps using colored gradients to represent the magnitude of refractive errors of the eye. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Individuals With Visual Aberrations
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jul 2011
- 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: Normal subjects over the age of 18 with visual abberations.
Who may be able to join
- male or female, at least 18 years of age
- no ocular abnormality other than refractive error
- patient in generally good \& stable overall health
- has not worn contact lenses (hard or gas permeable lenses for at least 3 weeks and soft lenses for at least 3 days) prior to the study exam
- corneal topography must be normal, as judged by the investigator
- topical anesthesia and mydriatics must be tolerated
- patient must be able to fixate steadily
- ability to understand and provide informed consent to participate in this study
Who cannot join
- history of ocular surgery
- history of ocular trauma, infection, disease, or abnormality other than refractive error
- myopia or hyperopia > 7.0 D, astigmatism >3.0 D
- uncorrectable visual acuity below 20/20
- abnormal corneal topography pattern including, but not limited to keratoconus, forme fruste keratoconus, or corneal warpage
- pupil sizes below 6.0 mm under mydriasis
Show all 11Show fewer
- iris problems including, but not limited to, coloboma and previous iris surgery
- ocular media problems, corneal, lens and/or vitreous opacities including, but not limited to cataract
- ocular movement abnormalities including, but not limited to, strabismus or nystagmus
- phenol red thread test (Zone Quick-Menicon Ltd) less than 9 mm/15 seconds
- pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
About this study
An aberrometer measures visual aberrations by mapping how light rays travel through the eye and by providing maps using colored gradients to represent the magnitude of refractive errors of the eye.
The purpose of this study is to compare 4 different aberrometers -Wavescan (Visx Technology), Zywave (Bausch \& Lomb), Ladarwave aberrometer (Alcon Inc.) and Allegro Analyzer (Alcon Inc). In particular, the investigators propose to focus on the ability of these devices to display the higher order visual aberrations and to compare the quality of outputs from these 4 devices in normal healthy subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Individuals With Visual AberrationsStudies 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
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Pineda, MD, Principal investigator, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230164
- Sponsor's protocol ID
- 09-03-016
- Status last verified
- Dec 2011
- First submitted
- 27 Oct 2010
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Four Different Aberrometers for Evaluation of Higher Order Visual Aberrations
- ClinicalTrials.gov ID
- NCT01230164
- Acronym / sponsor ID
- 09-03-016
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 28 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.
An aberrometer measures visual aberrations by mapping how light rays travel through the eye and by providing maps using colored gradients to represent the magnitude of refractive errors of the eye.
The purpose of this study is to compare 4 different aberrometers -Wavescan (Visx Technology), Zywave (Bausch \& Lomb), Ladarwave aberrometer (Alcon Inc.) and Allegro Analyzer (Alcon Inc). In particular, the investigators propose to focus on the ability of these devices to display the higher order visual aberrations and to compare the quality of outputs from these 4 devices in normal healthy subjects.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal subjects over the age of 18 with visual abberations.
Key inclusion criteria (8 listed)
- male or female, at least 18 years of age
- no ocular abnormality other than refractive error
- patient in generally good \& stable overall health
- has not worn contact lenses (hard or gas permeable lenses for at least 3 weeks and soft lenses for at least 3 days) prior to the study exam
- corneal topography must be normal, as judged by the investigator
Key exclusion criteria (11 listed)
- history of ocular surgery
- history of ocular trauma, infection, disease, or abnormality other than refractive error
- myopia or hyperopia > 7.0 D, astigmatism >3.0 D
- uncorrectable visual acuity below 20/20
- abnormal corneal topography pattern including, but not limited to keratoconus, forme fruste keratoconus, or corneal warpage
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 21 Dec 2011.
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.
Roberto Pineda, MD principal investigator
Massachusetts Eye and Ear Infirmary
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 Normal Individuals With Visual Aberrations, run by Massachusetts Eye and Ear Infirmary 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 8 inclusion and 11 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 21 Dec 2011. 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.
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 21 Dec 2011.