Patient Perception of Visual Quality and Function

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

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Daniel Chang, M.D.	Bakersfield	California	United States	93309

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: Cataract

Study Results

Participant Flow

Arm/Group Title	Pseudophakic
Arm/Group Description	. Administration of patient self assessment
Period Title: Overall Study
STARTED	301
COMPLETED	296
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Pseudophakic
Arm/Group Description	. Administration of patient self assessment
Overall Participants	296
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

Title	Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery
Description	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.
Time Frame	Baseline 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 Title	Pseudophakic
Arm/Group Description	. Administration of patient self assessment
Measure Participants	295
Monofocal participants requiring visual aids	71 24%
Accommodating participants requiring visual aids	8 2.7%
Multifocal participants requiring visual aids	9 3%

Adverse Events

Arm/Group Title	Pseudophakic
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
Total	0/296 (0%)
Other (Not Including Serious) Adverse Events
	Pseudophakic
	Affected / at Risk (%)	# Events
Total	0/296 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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