Patient Perception of Visual Quality and Function

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146599
• Other study ID #: QPRO-101-SIVQ
• Status: Completed
• Phase: N/A
• First received: May 20, 2014
• Last updated: September 10, 2015
• Start date: May 2014
• Est. completion date: July 2014

Study information

• Verified date: September 2015
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cataract

Intervention

Other:
• Administration of patient self-assessment

Locations

Country	Name	City	State
United States	Daniel Chang, M.D.	Bakersfield	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 1 week	No