CataractNCT02146599
Patient Perception of Visual Quality and Function
An observational study of Cataract, run by Abbott Medical Optics at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the visual quality and function of pseudophakic patients. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Administration of patient self-assessment
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jul 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Bilaterally-implanted pseudophakic subjects over 22 years of age who meet the inclusion criteria.
Who may be able to join
- Minimum 22 years of age
- Pseudophakic patients who have been bilaterally implanted with the same type of intraocular lenses in both eyes
- Ability to understand, read and write English to give consent and complete the study questionnaires
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits
- Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Other protocol-defined inclusion criteria might apply
Who cannot join
- Any ocular pathology of clinical significance, as determined by the investigator, that may affect visual outcomes or influence subjective ocular/visual symptoms
- Patient is pregnant or is lactating
- Concurrent participation or participation within 30 days prior in any other clinical trial
- Other protocol-defined exclusion criteria might apply
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the visual quality and function of pseudophakic patients.
- Conditions
- Cataract
- Being tested
- Administration of patient self-assessment
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of patient self-assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| Pseudophakic | Not described Receives: Other: Administration of patient self-assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery
Patients will be assessed at a baseline visit and a visit 1 week later to determine their use of corrective visual aids (i.e., spectacles, contact lenses) post Intraocular Lens (IOL) surgery.
Measured: Baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146599
- Sponsor's protocol ID
- QPRO-101-SIVQ
- Status last verified
- Sep 2015
- First submitted
- 20 May 2014
- Last updated
- 28 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perception of Visual Quality and Function
- ClinicalTrials.gov ID
- NCT02146599
- Acronym / sponsor ID
- QPRO-101-SIVQ
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Posted 7 Sep 2015
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 visual quality and function of pseudophakic patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pseudophakic | – | Other: Administration of patient self-assessment |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Bilaterally-implanted pseudophakic subjects over 22 years of age who meet the inclusion criteria.
Key inclusion criteria (6 listed)
- Minimum 22 years of age
- Pseudophakic patients who have been bilaterally implanted with the same type of intraocular lenses in both eyes
- Ability to understand, read and write English to give consent and complete the study questionnaires
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits
- Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Key exclusion criteria (4 listed)
- Any ocular pathology of clinical significance, as determined by the investigator, that may affect visual outcomes or influence subjective ocular/visual symptoms
- Patient is pregnant or is lactating
- Concurrent participation or participation within 30 days prior in any other clinical trial
- Other protocol-defined exclusion criteria might apply
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 |
|---|---|---|
| Administration of patient self-assessment | Other | Pseudophakic |
Primary outcome
Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery
Time frame: Baseline and 1 week
Patients will be assessed at a baseline visit and a visit 1 week later to determine their use of corrective visual aids (i.e., spectacles, contact lenses) post Intraocular Lens (IOL) surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cataract, run by Abbott Medical Optics 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 6 inclusion and 4 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 28 Sep 2015. 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?
Yes. Results are posted in the registry (first posted 7 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery (time frame: Baseline and 1 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 28 Sep 2015.