Trial Outcomes & Findings for Safety and Effectiveness of a Multifocal Intraocular Lens (IOL) (NCT NCT00747565)

Results Overview

Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,"first eye" refers to the first implanted eye of each subject.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

470 participants

Primary outcome timeframe

One year

Results posted on

2025-02-04

Participant Flow

Multifocal and monofocal control subjects were enrolled in the original study in 2004-2005 from the normal cataract populations at 13 USA sites. In the expansion study, additional multifocal subjects were enrolled from the normal cataract populations at 16 USA sites (13 who also participated in the original study) in 2007.

Subjects chose which type of lens to receive (multifocal or monofocal) in the original study. Subjects only received the multifocal lens in the expansion study.

Participant milestones

Participant milestones
Measure	Tecnis Multifocal Subjects Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.	Monofocal Control Subjects Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
Overall Study STARTED	347	123
Overall Study COMPLETED	333	116
Overall Study NOT COMPLETED	14	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Tecnis Multifocal Subjects Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.	Monofocal Control Subjects Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
Overall Study Withdrawal by Subject	10	6
Overall Study Lost to Follow-up	4	1

Baseline Characteristics

Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tecnis Multifocal Subjects n=347 Participants Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.	Monofocal Control Subjects n=123 Participants Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.	Total n=470 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	144 Participants n=5 Participants	27 Participants n=7 Participants	171 Participants n=5 Participants
Age, Categorical >=65 years	203 Participants n=5 Participants	96 Participants n=7 Participants	299 Participants n=5 Participants
Age, Continuous	65.9 years STANDARD_DEVIATION 9.5 • n=5 Participants	68.7 years STANDARD_DEVIATION 8.9 • n=7 Participants	66.7 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	211 Participants n=5 Participants	81 Participants n=7 Participants	292 Participants n=5 Participants
Sex: Female, Male Male	136 Participants n=5 Participants	42 Participants n=7 Participants	178 Participants n=5 Participants
Region of Enrollment United States	347 participants n=5 Participants	123 participants n=7 Participants	470 participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: First eye results from subjects at one year in both the original study and the expansion study combined.

Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,"first eye" refers to the first implanted eye of each subject.

Outcome measures

Outcome measures
Measure	Tecnis Multifocal Subjects n=331 Participants Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.	Monofocal Control Subjects n=114 Participants Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.	329 Participants (First Eyes only)	114 Participants (First Eyes only)

PRIMARY outcome

Timeframe: One year

Population: Binocular subjects at one year available for testing for both studies combined.

Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.

Outcome measures

Outcome measures
Measure	Tecnis Multifocal Subjects n=291 Participants Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints.	Monofocal Control Subjects n=113 Participants Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
Mean Binocular Distance Corrected Near Visual Acuity in Snellen	24 Mean Snellen Line (with ETDRS line SD) Standard Deviation 1.09	70 Mean Snellen Line (with ETDRS line SD) Standard Deviation 1.64

Adverse Events

Tecnis Multifocal Subjects

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

Monofocal Control Subjects

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tecnis Multifocal Subjects n=348 participants at risk Note: only outcomes of the first eye implanted of each Tecnis Multifocal subject were analyzed for primary endpoints. One additional multifocal subject was enrolled but received an incorrect lens; this subject is included for adverse event reporting for a total of 348 (347 +1) multifocal subjects.	Monofocal Control Subjects n=123 participants at risk Note: Only outcomes of the first eye implanted of each monofocal control subject were analyzed for primary endpoints.
Eye disorders Endophthalmitis, hypopyon and surgical intervention	0.29% 1/348 • Number of events 5	0.00% 0/123
Eye disorders Signifcant loss in vision due to stroke	0.29% 1/348 • Number of events 1	0.00% 0/123
Eye disorders Lens-related lens removal	0.29% 1/348 • Number of events 1	0.00% 0/123
Eye disorders Lens-related other surgical procedures	0.29% 1/348 • Number of events 1	0.00% 0/123
Eye disorders Non-lens-related lens exchange	1.1% 4/348 • Number of events 4	0.00% 0/123
Eye disorders Non-lens-related other surgical procedures	1.7% 6/348 • Number of events 6	0.81% 1/123 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Nicholas Tarantino, O.D., Head, Global Clinical Research & Development

Abbott Medical Optics, Inc.

Phone: 866-427-8477

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PIs may not publish or disclose study data without Sponsor's prior written approval.
Publication restrictions are in place

Restriction type: OTHER