Visual FunctionNCT00894192
Comprehensive Evaluation of Visual Function
A study testing Izon Wavefront-guided lenses and Conventional lenses in people with Visual Function, run by The Chicago Lighthouse at 1 site in United States.
Trial summary
The purpose of this study is to assess the level of visual functioning in patients with various eye conditions while wearing different types of eyeglasses. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Function
- What is being tested?
- Izon Wavefront-guided lenses and Conventional lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 2009
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have normal vision
- Are far-sighted or near-sighted
- Have no eye diseases Subjects aged 18 and over, who have refractive errors ranging from +5.0 to -5.0 and/or who have eye disease will be included in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Chicago Lighthouse
Chicago, Illinois, 60608
Samar Suleman, BA, 312-447-3234, samar.suleman@chicagolighthouse.org
Janet Szlyk, PhD
About this study
The purpose of this study is to assess the level of visual functioning in patients with various eye conditions while wearing different types of eyeglasses.
Read the detailed description
The purpose of the research is to study the level of visual functioning in individuals with various eye conditions when using different types of eyeglass lenses. Therefore, the goal of this study is to determine factors that may account for variability in the visual functioning of individuals with a range of refractive errors and their ability to perform everyday activities when equipped with different types of lenses. We hypothesize that the subjects will perform visual tasks of function better when using iZon™ Wavefront-Guided Glasses than with conventional glasses. This hypothesis is based upon the glasses yielding better visual acuity and because the design of the glasses reduces the effects of glare. This research is important so that alternate treatments and vision correction may be implemented which will have a more beneficial impact on those with refractive errors and visual impairment.
- Conditions
- Visual Function
- Being tested
- Izon Wavefront-guided lenses, Conventional lenses
- Keywords
- This study tests functional ability of patients with refractive error or normal vision while using different types of eyeglasses.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Izon Wavefront-guided lensesDevice
Subjects will use prescribed eyeglasses for one week. Their visual functioning will be tested at the end of the week.
Conventional lensesDevice
We will test the subjects with these lenses after they have worn them for one week. Same procedures will be followed as with the other lenses.
| Study group | Role | What they receive |
|---|---|---|
| Wavefront guided lenses | Active comparator | Not described Receives: Device: Izon Wavefront-guided lenses |
| Conventional lenses | Placebo comparator | Not described Receives: Device: Conventional lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity, and Contrast Sensitivity
Measured: Once a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual FunctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Chicago Lighthouse
- Sponsor type
- University, hospital or other
- Collaborators
- Ophthonix Inc, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894192
- Sponsor's protocol ID
- OPH-2005-0516
- Status last verified
- May 2009
- First submitted
- 4 May 2009
- Last updated
- 6 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Evaluation of Visual Function
- ClinicalTrials.gov ID
- NCT00894192
- Acronym / sponsor ID
- OPH-2005-0516
- Conditions
- Visual Function
- Keywords
- This study tests functional ability of patients with refractive error or normal vision while using different types of eyeglasses.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Chicago LighthouseUniversity, hospital or other
- Collaborators
- Ophthonix Inc, University of Illinois at Chicago
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 6 May 2009 (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 assess the level of visual functioning in patients with various eye conditions while wearing different types of eyeglasses.
Detailed description
The purpose of the research is to study the level of visual functioning in individuals with various eye conditions when using different types of eyeglass lenses. Therefore, the goal of this study is to determine factors that may account for variability in the visual functioning of individuals with a range of refractive errors and their ability to perform everyday activities when equipped with different types of lenses. We hypothesize that the subjects will perform visual tasks of function better when using iZon™ Wavefront-Guided Glasses than with conventional glasses. This hypothesis is based upon the glasses yielding better visual acuity and because the design of the glasses reduces the effects of glare. This research is important so that alternate treatments and vision correction may be implemented which will have a more beneficial impact on those with refractive errors and visual impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wavefront guided lenses | Active comparator | Device: Izon Wavefront-guided lenses |
| Conventional lenses | Placebo comparator | Device: Conventional lenses |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Have normal vision
- Are far-sighted or near-sighted
- Have no eye diseases Subjects aged 18 and over, who have refractive errors ranging from +5.0 to -5.0 and/or who have eye disease will be included in the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Izon Wavefront-guided lensesSubjects will use prescribed eyeglasses for one week. Their visual functioning will be tested at the end of the week. | Device | Wavefront guided lenses |
| Conventional lensesWe will test the subjects with these lenses after they have worn them for one week. Same procedures will be followed as with the other lenses. | Device | Conventional lenses |
Primary outcome
Visual Acuity, and Contrast Sensitivity
Time frame: Once a week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Izon Wavefront-guided lenses and Conventional lenses in people with Visual Function, run by The Chicago Lighthouse 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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 6 May 2009. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samar Suleman, BA (312-447-3234, samar.suleman@chicagolighthouse.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity, and Contrast Sensitivity (time frame: Once a week). 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 6 May 2009; AzTrials last refreshed its copy on 27 Oct 2026.