Patient Perception of Visual Quality and Function

NCT02146599 — Completed, 301 participants, Abbott Medical Optics

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT02146599
StatusCompleted
Study typeObservational
Enrollment301 (Actual)
SponsorAbbott Medical Optics (Industry)
ConditionsCataract
InterventionsAdministration of patient self-assessment (Other)
Datesstart 2014-05-01, primary completion 2014-07-01, completion 2014-07-01, first posted 2014-05-26, last updated 2015-09-28
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Cataract All trials of Administration of patient self-assessment

-Summary

The purpose of this study is to evaluate the visual quality and function of pseudophakic patients.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
PseudophakicOther: Administration of patient self-assessment
  • Administration of patient self-assessment (Other)

+Outcome measures

Primary outcomes

  • Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery [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

Sex: All, ages: 22 Years to any, accepts healthy volunteers

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

+Posted results

Participant flow

MilestonePseudophakic
Started301
Completed296
Not completed5

Outcome results

  • Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery (Primary), Number, participants: Pseudophakic 71

Adverse events

ArmDeathsSerious adverse eventsOther adverse events
Pseudophakic00/296 (0.0%)0/296 (0.0%)

+Locations (1)

FacilityCityCountryStatus
Daniel Chang, M.D.Bakersfield, CaliforniaUnited States