Trial Outcomes & Findings for One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction (NCT NCT01230060)

NCT ID: NCT01230060

Last Updated: 2013-08-22

Results Overview

Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 122 participants
• Primary outcome timeframe: 120-180 days (visit 4)
• Results posted on: 2013-08-22

Participant Flow

This study was conducted at 6 clinical sites in the US. Study started Aug 2010 and was completed June 2011.

122 subjects underwent cataract extraction and implantation of the Bausch + Lomb Intraocular Lens (IOL) for the correction of aphakia.

Participant milestones

Measure	enVista enVista One-Piece Hydrophobic Acrylic Intraocular Lens enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.
Overall Study STARTED	122
Overall Study COMPLETED	121
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	enVista enVista One-Piece Hydrophobic Acrylic Intraocular Lens enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction

Baseline characteristics by cohort

Measure	enVista n=122 Participants enVista One-Piece Hydrophobic Acrylic Intraocular Lens enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.
Age Continuous	69.0 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Region of Enrollment United States	122 participants n=5 Participants

PRIMARY outcome

Timeframe: 120-180 days (visit 4)

Population: All non missing implanted eyes, consistent set

Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.

Outcome measures

Measure	enVista n=108 Participants enVista One-Piece Hydrophobic Acrylic Intraocular Lens enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.
Visual Acuity	108 Participants Interval 96.6 to 100.0

Adverse Events

enVista

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	enVista n=122 participants at risk enVista One-Piece Hydrophobic Acrylic Intraocular Lens enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.
Blood and lymphatic system disorders Acute myeloid leukemia	0.82% 1/122 • Number of events 1 • 140-180 days

Other adverse events

Adverse event data not reported

Additional Information

Jon Hayashida

Bausch & Lomb Incorporated

Phone: (949) 521-7876

Email: jon.hayashida@bausch.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER