Trial Outcomes & Findings for Patient Perception of Visual Quality and Function (NCT NCT02146599)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

301 participants

Primary outcome timeframe

Baseline and 1 week

Results posted on

2015-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Pseudophakic . Administration of patient self assessment
Overall Study STARTED	301
Overall Study COMPLETED	296
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Pseudophakic . Administration of patient self assessment
Overall Study Failed to meet inclusion criteria	5

Baseline Characteristics

Patient Perception of Visual Quality and Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pseudophakic n=296 Participants . Administration of patient self assessment
Age, Continuous	68.79 years STANDARD_DEVIATION 8.23 • n=93 Participants
Sex: Female, Male Female	194 Participants n=93 Participants
Sex: Female, Male Male	102 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 1 week

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pseudophakic n=295 Participants . Administration of patient self assessment
Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery Monofocal participants requiring visual aids	71 participants
Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery Accommodating participants requiring visual aids	8 participants
Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery Multifocal participants requiring visual aids	9 participants

Adverse Events

Pseudophakic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anne Buteyn; Manager, Clinical Research

Abbott Medical Optics

Phone: 949-505-2029

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER