Patient Perception of Visual Quality and Function

Sponsor
Abbott Medical Optics (Industry)
Overall Status
Completed
CT.gov ID
NCT02146599
Collaborator
(none)
301
Enrollment
1
Location
2
Duration (Months)
150.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Administration of patient self-assessment

Study Design

Study Type:
Observational
Actual Enrollment :
301 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

ArmIntervention/Treatment
Pseudophakic

Other: Administration of patient self-assessment

Outcome Measures

Primary Outcome Measures

  1. 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 Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

SiteCityStateCountryPostal Code
1Daniel Chang, M.D.BakersfieldCaliforniaUnited States93309

Sponsors and Collaborators

  • Abbott Medical Optics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT02146599
Other Study ID Numbers:
  • QPRO-101-SIVQ
First Posted:
May 26, 2014
Last Update Posted:
Sep 28, 2015
Last Verified:
Sep 1, 2015
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitlePseudophakic
Arm/Group Description. Administration of patient self assessment
Period Title: Overall Study
STARTED301
COMPLETED296
NOT COMPLETED5

Baseline Characteristics

Arm/Group TitlePseudophakic
Arm/Group Description. Administration of patient self assessment
Overall Participants296
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
68.79
(8.23)
Sex: Female, Male (Count of Participants)
Female
194
65.5%
Male
102
34.5%

Outcome Measures

1. Primary Outcome
TitleUse of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery
DescriptionPatients 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.
Time FrameBaseline and 1 week

Outcome Measure Data

Analysis Population Description
Of the 295 participants who provided data for this analysis (monofocal participants , n=138; accommodating participants, n=34; and multifocal participants, n=123), corrective visual aids (i.e., spectacles, contact lenses) post intraocular lens (IOL) surgery were required by 88 participants.
Arm/Group TitlePseudophakic
Arm/Group Description. Administration of patient self assessment
Measure Participants295
Monofocal participants requiring visual aids
71
24%
Accommodating participants requiring visual aids
8
2.7%
Multifocal participants requiring visual aids
9
3%

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group TitlePseudophakic
Arm/Group Description. Administration of patient self assessment
All Cause Mortality
Pseudophakic
Affected / at Risk (%)# Events
Total/ (NaN)
Serious Adverse Events
Pseudophakic
Affected / at Risk (%)# Events
Total0/296 (0%)
Other (Not Including Serious) Adverse Events
Pseudophakic
Affected / at Risk (%)# Events
Total0/296 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results Point of Contact

Name/TitleAnne Buteyn; Manager, Clinical Research
OrganizationAbbott Medical Optics
Phone949-505-2029
Emailanne.buteyn@abbott.com
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT02146599
Other Study ID Numbers:
  • QPRO-101-SIVQ
First Posted:
May 26, 2014
Last Update Posted:
Sep 28, 2015
Last Verified:
Sep 1, 2015