Trial Outcomes & Findings for Clinical Evaluation of a 1-Piece Intraocular Lens (NCT NCT01098812)

Last Updated: 2025-02-04

Results Overview

Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

269 participants

Primary outcome timeframe

6 months after second eye implant compared to baseline

Results posted on

2025-02-04

Participant Flow

Subjects were enrolled from normal cataract populations at 14 investigative sites.

Subjects with low cylinder were enrolled in a randomized group and received either the control lens or the investigational Toric IOL. Subjects with higher cylinder were enrolled in the high cylinder group and received a higher cylinder investigational Toric IOL.

Participant milestones

Participant milestones
Measure	ZCB00 Approved Intraocular control lens	Toric IOL Investigational Toric IOL	Higher Cylinder Toric IOL Investigational toric IOLs with higher cylinder powers.
Overall Study STARTED	95	102	72
Overall Study COMPLETED	93	101	71
Overall Study NOT COMPLETED	2	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ZCB00 Approved Intraocular control lens	Toric IOL Investigational Toric IOL	Higher Cylinder Toric IOL Investigational toric IOLs with higher cylinder powers.
Overall Study Death	2	0	1
Overall Study Lost to Follow-up	0	1	0

Baseline Characteristics

Clinical Evaluation of a 1-Piece Intraocular Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ZCB00 n=95 Participants Approved Intraocular control lens	Toric IOL n=102 Participants Investigational Toric IOL	Higher Cylinder Toric IOL n=72 Participants Investigational toric IOLs with higher cylinder powers.	Total n=269 Participants Total of all reporting groups
Age, Continuous	71 years STANDARD_DEVIATION 9 • n=5 Participants	70 years STANDARD_DEVIATION 8 • n=7 Participants	69 years STANDARD_DEVIATION 9 • n=5 Participants	70 years STANDARD_DEVIATION 9 • n=4 Participants
Age, Customized <60 years	5 participants n=5 Participants	10 participants n=7 Participants	7 participants n=5 Participants	22 participants n=4 Participants
Age, Customized 60 through 69 years	36 participants n=5 Participants	39 participants n=7 Participants	33 participants n=5 Participants	108 participants n=4 Participants
Age, Customized 70 through 79 years	36 participants n=5 Participants	41 participants n=7 Participants	25 participants n=5 Participants	102 participants n=4 Participants
Age, Customized >=80 years	18 participants n=5 Participants	12 participants n=7 Participants	7 participants n=5 Participants	37 participants n=4 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	55 Participants n=7 Participants	40 Participants n=5 Participants	150 Participants n=4 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	47 Participants n=7 Participants	32 Participants n=5 Participants	119 Participants n=4 Participants
Region of Enrollment United States	87 participants n=5 Participants	94 participants n=7 Participants	66 participants n=5 Participants	247 participants n=4 Participants
Region of Enrollment Canada	8 participants n=5 Participants	8 participants n=7 Participants	6 participants n=5 Participants	22 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months after second eye implant compared to baseline

Population: Subjects at the final visit with preoperative keratometric cylinder, intended/target cylinder and postoperative refractive cylinder.

Outcome measures

Outcome measures
Measure	Control IOL n=91 Participants Approved Intraocular control lens	Toric IOL n=101 Participants Investigational Toric IOL	Higher Cylinder Toric IOL n=70 Participants Investigational Toric IOLs with higher cylinder powers.
Mean Percent Reduction in Cylinder	32 percentage of reduction in cylinder Standard Deviation 79	75 percentage of reduction in cylinder Standard Deviation 72	76. percentage of reduction in cylinder Standard Deviation 33

SECONDARY outcome

Timeframe: 6 months after second eye implant

Population: Available subjects at the final visit with measured uncorrected distance visual acuity.

Postoperative uncorrected distance visual acuity as measured by LogMAR acuity. For comparison: LogMAR value of 0.0 = Snellen 20/20; LogMar 0.10 = Snellen 20/25; LogMAR 0.20 = Snellen 20/32; LogMAR 0.30 = Snellen 20/40. Uncorrected distance visual acuity as measured by LogMAR acuity was assessed in the first eye (per participant) for contribution to the mean.

Outcome measures

Outcome measures
Measure	Control IOL n=93 Participants Approved Intraocular control lens	Toric IOL n=101 Participants Investigational Toric IOL	Higher Cylinder Toric IOL n=71 Participants Investigational Toric IOLs with higher cylinder powers.
Uncorrected Distance Visual Acuity (UCDVA)	0.16 LogMAR acuity values Standard Deviation 0.16	0.10 LogMAR acuity values Standard Deviation 0.14	0.11 LogMAR acuity values Standard Deviation 0.12

Adverse Events

ZCB00

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

All Toric IOLs

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ZCB00 n=95 participants at risk Approved Intraocular control lens	All Toric IOLs n=174 participants at risk Investigational Toric IOLs including high cylinder powers
Eye disorders Lens Repositioning Procedure	0.00% 0/95	2.3% 4/174 • Number of events 4
Eye disorders Retinal Repair	0.00% 0/95	1.1% 2/174 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Kristen Featherstone

Abbott Medical Optics

Phone: 714-247-8621

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Study results may be published by PI upon written approval by sponsor (AMO). Any proposed submission for publication or presentation of study data must be provided to AMO 90 days prior to submission for review, comment and approval. Sponsor may delay or withhold submission as necessary (ongoing study activities, patents pending, etc.).
Publication restrictions are in place

Restriction type: OTHER