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Patient Perception of Visual Quality and Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02146599
Recruitment Status : Completed
First Posted : May 26, 2014
Results First Posted : September 7, 2015
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Description
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Brief Summary:
The purpose of this study is to evaluate the visual quality and function of pseudophakic patients.

Condition or disease Intervention/treatment
Cataract Other: Administration of patient self-assessment

Study Design
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Study Type : Observational
Actual Enrollment : 301 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : May 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014
Groups and Cohorts
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Group/Cohort Intervention/treatment
Pseudophakic Other: Administration of patient self-assessment


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Bilaterally-implanted pseudophakic subjects over 22 years of age who meet the inclusion criteria.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146599


Locations
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United States, California
Daniel Chang, M.D.
Bakersfield, California, United States, 93309
Sponsors and Collaborators
Abbott Medical Optics
More Information
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Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT02146599    
Other Study ID Numbers: QPRO-101-SIVQ
First Posted: May 26, 2014    Key Record Dates
Results First Posted: September 7, 2015
Last Update Posted: September 28, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases