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Patient Perception of Visual Distortions

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ClinicalTrials.gov Identifier: NCT02203747
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : December 22, 2015
Last Update Posted : December 22, 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 visual distortions reported by pseudophakic patients.

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

Study Design
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Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : January 2015
Groups and Cohorts
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Group/Cohort Intervention/treatment
Pseudophakic implanted with toric IOL
Subjects bilaterally implanted with toric IOL
 Other: Administration of patient self-assessment
Pseudophakic implanted with non-toric IOL
Subjects bilaterally implanted with non-toric IOL
 Other: Administration of patient self-assessment


Outcome Measures
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Primary Outcome Measures :
  1. Visual Distortion Symptoms [ Time Frame: Baseline ]
    Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: "did not experience" (rating = 0), "mild" (rating = 1), "moderate" (rating = 2), or "severe" (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.

  2. Visual Distortion Symptoms [ Time Frame: 1 week ]
    Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: "did not experience" (rating = 0), "mild" (rating = 1), "moderate" (rating = 2), or "severe" (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3.


Eligibility Criteria
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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 with astigmatism who meet the inclusion criteria.
Criteria

Inclusion Criteria:

  • Corneal astigmatism of at least 0.75 diopters
  • Bilaterally-implanted with monofocal toric intraocular lenses in both eyes or with monofocal non-toric intraocular lenses in both eyes
  • At least one month postoperative from second-eye surgery
  • Ability to understand, read and write English to give consent and complete study questionnaire
  • Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits
  • Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Any ocular pathology of clinical significance, as determined by the investigator, other than regular corneal astigmatism, that may affect visual outcomes or influence subjective ocular visual symptoms
  • Patient is pregnant or is lactating
  • Participation in any other clinical trial during the last 30 days prior to study enrollment or concurrent participation in any other ongoing clinical trial
  • Other protocol-defined exclusion criteria may 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): NCT02203747


Locations
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United States, California
Contact AMO for Trial Locations
Santa Ana, California, United States, 92705
Sponsors and Collaborators
Abbott Medical Optics
More Information
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Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT02203747    
Other Study ID Numbers: TIOL-201-VPAS
First Posted: July 30, 2014    Key Record Dates
Results First Posted: December 22, 2015
Last Update Posted: December 22, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors