Ocular Refractive AberrationsNCT00344864
A Prospective Clinical Research Project Evaluating The Effects of Soft Contact Lenses on Higher Order Visual Aberrations
An observational study of Ocular Refractive Aberrations, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
High order aberrations (HOA) are visual phenomena that decrease quality of vision. Examples of high order aberration are glare, halos, decreased contrast sensitivity and shape distortion. They are caused by slight imperfections or distortions in the corneal surface. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Refractive Aberrations
- What is being tested?
- LADARWave
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2006to Apr 2007
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All patients of any race and sex between the ages of 18-35 years of age who are not currently wearing contact lenses at their initial presentation.
Who may be able to join
- All patients of any race and sex between the ages of 18-35 years of age who are not currently wearing contact lenses at their initial presentation. Only patients who voluntarily agree to participate in the study will be included. These potential subjects would be selected after reviewing and signing the Informed Consent (IC) as well as HIPAA authorization forms. The Principal Investigator (PI) or his designee will introduce the study to the patient, thoroughly explaining the details of the study. Copies of the forms will be placed in the patient medical record as well as given to study patient.
Who cannot join
- Patients under the age of 18 or over the age of 35 will be excluded. Patients with any ocular pathology, previous eye surgery and/or uveitis will be excluded. Also, any patient who does not choose to participate will be excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Aston Ambulatory Care Center
Dallas, Texas, 75390-8866
UTSW Medical Center At Dallas
Dallas, Texas, 75390-8866
About this study
High order aberrations (HOA) are visual phenomena that decrease quality of vision. Examples of high order aberration are glare, halos, decreased contrast sensitivity and shape distortion. They are caused by slight imperfections or distortions in the corneal surface. HOA are currently measured using a variety of FDA approved devices. For this study, the LADARWave (Alcon) will be used to measure HOA. This device uses a harmless beam of light. It is FDA approved and non-invasive. Contact lens induced high order aberrations have never been measured and reported in the literature. This work may provide information to guide future contact lens design.
Read the detailed description
Patients will be recruited from the Aston optometry clinic. The pool of patients included in the study will be from those who have voluntarily scheduled appointments for contact lenses. During the patient's initial visit, the study will be explained to them and they will have a choice of whether or not to take part with no penalty for refusal. If a patient agrees to take part in the study, they will have their HOA measured with the LADARWave instrument prior to contact lens insertion and right after contact lens insertion. Patients will then return for visits both one week and one month later for follow up measurements at the time of their regularly scheduled visits.
- Conditions
- Ocular Refractive Aberrations
- Being tested
- LADARWave
- Keywords
- Contact Lenses Higher Order Aberrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LADARWaveDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether Soft contact lenses induce High order aberrations (HOA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: Terminated due to lack of patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Refractive AberrationsStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Paul Sanchez, MD, Principal investigator, UTSW Medical Center At DallasJames McCulley, MD, Study chair, UTSW Medical Center Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344864
- Sponsor's protocol ID
- Sanchez001
- Status last verified
- May 2007
- First submitted
- 23 Jun 2006
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Research Project Evaluating The Effects of Soft Contact Lenses on Higher Order Visual Aberrations
- ClinicalTrials.gov ID
- NCT00344864
- Acronym / sponsor ID
- Sanchez001
- Conditions
- Ocular Refractive Aberrations
- Keywords
- Contact Lenses Higher Order Aberrations
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to lack of patient recruitment
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 27 Jun 2006 (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.
High order aberrations (HOA) are visual phenomena that decrease quality of vision. Examples of high order aberration are glare, halos, decreased contrast sensitivity and shape distortion. They are caused by slight imperfections or distortions in the corneal surface. HOA are currently measured using a variety of FDA approved devices. For this study, the LADARWave (Alcon) will be used to measure HOA. This device uses a harmless beam of light. It is FDA approved and non-invasive. Contact lens induced high order aberrations have never been measured and reported in the literature. This work may provide information to guide future contact lens design.
Detailed description
Patients will be recruited from the Aston optometry clinic. The pool of patients included in the study will be from those who have voluntarily scheduled appointments for contact lenses. During the patient's initial visit, the study will be explained to them and they will have a choice of whether or not to take part with no penalty for refusal. If a patient agrees to take part in the study, they will have their HOA measured with the LADARWave instrument prior to contact lens insertion and right after contact lens insertion. Patients will then return for visits both one week and one month later for follow up measurements at the time of their regularly scheduled visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients of any race and sex between the ages of 18-35 years of age who are not currently wearing contact lenses at their initial presentation.
Key inclusion criteria (1 listed)
- All patients of any race and sex between the ages of 18-35 years of age who are not currently wearing contact lenses at their initial presentation. Only patients who voluntarily agree to participate in the study will be included. These potential subjects would be selected after reviewing and signing the Informed Consent (IC) as well as HIPAA authorization forms. The Principal Investigator (PI) or his designee will introduce the study to the patient, thoroughly explaining the details of the study. Copies of the forms will be placed in the patient medical record as well as given to study patient.
Key exclusion criteria (1 listed)
- Patients under the age of 18 or over the age of 35 will be excluded. Patients with any ocular pathology, previous eye surgery and/or uveitis will be excluded. Also, any patient who does not choose to participate will be excluded.
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 |
|---|---|---|
| LADARWave | Device | – |
Primary outcome
Whether Soft contact lenses induce High order aberrations (HOA)
Results and safety
The study was stopped early (reason given: Terminated due to lack of patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 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.
Paul Sanchez, MD principal investigator
UTSW Medical Center At Dallas
James McCulley, MD study chair
UTSW Medical Center Dallas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Refractive Aberrations, run by University of Texas Southwestern Medical Center at 2 sites 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: stopped early, as of the sponsor's last update on 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Terminated due to lack of patient 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?
Whether Soft contact lenses induce High order aberrations (HOA). 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 23 Mar 2011.