Patient Perception of Visual Quality and Function

NCT02146599 | Completed Results

• 1 other identifier: QPRO-101-SIVQ
• Study Type: observational
• Target: 301
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pseudophakic

Other: Administration of patient self-assessment

Interventions

Administration of patient self-assessment OTHER

Pseudophakic

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bilaterally-implanted pseudophakic subjects over 22 years of age who meet the inclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Optics: lead

Study Sites (1)

Daniel Chang, M.D.

Bakersfield, California, 93309, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Anne Buteyn; Manager, Clinical Research
• Organization: Abbott Medical Optics

anne.buteyn@abbott.com

949-505-2029

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 26, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 28, 2015
• Results First Posted: September 7, 2015

Record last verified: 2015-09

Locations

US (1)