Trial Outcomes & Findings for Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models (NCT NCT03856944)

Results Overview

Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

3 months

Results posted on

2021-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	ReSTOR Toric Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Overall Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Age, Continuous	69 years STANDARD_DEVIATION 9 • n=29 Participants
Sex: Female, Male Female	18 Participants n=29 Participants
Sex: Female, Male Male	11 Participants n=29 Participants
Region of Enrollment United States	29 Participants n=29 Participants

PRIMARY outcome

Timeframe: 3 months

Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Residual Refractive Cylinder	0.02 diopters Standard Deviation 0.08

SECONDARY outcome

Timeframe: 3 months

Monocular uncorrected near visual acuity measuring in logMAR

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Monocular Uncorrected Near Visual Acuity	0.12 logMAR Standard Deviation 0.11

SECONDARY outcome

Timeframe: 3 months

Monocular uncorrected distance visual acuity measured in logMAR notation

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Monocular Uncorrected Distance Visual Acuity	0.04 logMAR Standard Deviation 0.09

SECONDARY outcome

Timeframe: 3 months

Monocular Uncorrected intermediate visual acuity measured in logMAR notation (log of the minimum angle of resolution)

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Monocular Uncorrected Intermediate Visual Acuity	0.06 logMAR Standard Deviation 0.11

SECONDARY outcome

Timeframe: 3 months

Monocular best corrected distance visual acuity measured in logMAR notation

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Monocular Best Corrected Distance Visual Acuity	.04 logMAR Standard Deviation .09

SECONDARY outcome

Timeframe: 3 months

Monocular best distance-corrected intermediate visual acuity in logMAR notation

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Monocular Best Distance-corrected Intermediate Visual Acuity	.06 logMAR Standard Deviation .11

SECONDARY outcome

Timeframe: 3 months

Monocular best distance-corrected near visual acuity measured in logMAR notation

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Monocular Best Distance-corrected Near Visual Acuity	.11 logMAR Standard Deviation 0.12

SECONDARY outcome

Timeframe: 3 months

Binocular uncorrected near (40cm) visual acuity measured in logMAR notation

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Binocular Uncorrected Near Visual Acuity	0.01 logMAR Standard Deviation 0.08

SECONDARY outcome

Timeframe: 3 months

Binocular uncorrected distance visual acuity measured in logMAR notation

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Binocular Uncorrected Distance Visual Acuity	-0.01 logMAR Standard Deviation 0.07

SECONDARY outcome

Timeframe: 3 months

Binocular uncorrected intermediate (60cm) visual acuity

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Binocular Uncorrected Intermediate Visual Acuity	-0.02 logMAR Standard Deviation 0.07

SECONDARY outcome

Timeframe: 3 months

Binocular best-corrected distance visual acuity measured in logMAR notation

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Binocular Best-corrected Distance Visual Acuity	-0.03 logMAR Standard Deviation 0.05

SECONDARY outcome

Timeframe: 3 months

Binocular best distance-corrected intermediate (60cm) visual acuity

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Binocular Best Distance-corrected Intermediate Visual Acuity	-0.06 logMAR Standard Deviation 0.03

SECONDARY outcome

Timeframe: 3 months

Binocular best distance-corrected near (40cm) visual acuity

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Binocular Best Distance-corrected Near Visual Acuity	0.01 logMAR Standard Deviation 0.01

SECONDARY outcome

Timeframe: 3 months

Population: Subjects are enrolled, eyes (2x subjects) were evaluated for some tests.

Postoperative orientation changes with the Toric ReSTOR IOL up to 3 months after surgery will be measured by determining the angle of orientation of the IOL in degrees (0-180) using a slit lamp.

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=58 Eyes Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
IOL Orientation	56 Eyes with < 5 degrees rot'n from 1-3 mos

SECONDARY outcome

Timeframe: 3 months

Binocular best distance-corrected defocus curve.

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Binocular Best Distance-corrected Defocus Curve Defocus +1.00	.24 logMAR Acuity Standard Deviation .20
Binocular Best Distance-corrected Defocus Curve Defocus +0.50	.07 logMAR Acuity Standard Deviation .11
Binocular Best Distance-corrected Defocus Curve Defocus 0.00	-.01 logMAR Acuity Standard Deviation 0.07
Binocular Best Distance-corrected Defocus Curve Defocus -4.00	.55 logMAR Acuity Standard Deviation .19
Binocular Best Distance-corrected Defocus Curve Defocus -3.50	.40 logMAR Acuity Standard Deviation .15
Binocular Best Distance-corrected Defocus Curve Defocus -3.00	.28 logMAR Acuity Standard Deviation .12
Binocular Best Distance-corrected Defocus Curve Defocus -2.50	.19 logMAR Acuity Standard Deviation .11
Binocular Best Distance-corrected Defocus Curve Defocus -2.00	.16 logMAR Acuity Standard Deviation .11
Binocular Best Distance-corrected Defocus Curve Defocus -1.50	.21 logMAR Acuity Standard Deviation .11
Binocular Best Distance-corrected Defocus Curve Defocus -1.00	.19 logMAR Acuity Standard Deviation .08
Binocular Best Distance-corrected Defocus Curve Defocus -0.50	0.08 logMAR Acuity Standard Deviation 0.10

SECONDARY outcome

Timeframe: 3 months

Binocular uncorrected defocus curve, from +1.0D to -4.00D in 0.50D increments

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=27 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Binocular Uncorrected Defocus Curve. Defocus 1.00	.22 logMAR Acuity Standard Deviation .20
Binocular Uncorrected Defocus Curve. Defocus 0.50	.07 logMAR Acuity Standard Deviation .11
Binocular Uncorrected Defocus Curve. Defocus 0.00	-.01 logMAR Acuity Standard Deviation .08
Binocular Uncorrected Defocus Curve. Defocus -4.00	.55 logMAR Acuity Standard Deviation .19
Binocular Uncorrected Defocus Curve. Defocus -3.50	.41 logMAR Acuity Standard Deviation .16
Binocular Uncorrected Defocus Curve. Defocus -3.00	.29 logMAR Acuity Standard Deviation 0.13
Binocular Uncorrected Defocus Curve. Defocus -2.50	.18 logMAR Acuity Standard Deviation .11
Binocular Uncorrected Defocus Curve. Defocus -2.00	.16 logMAR Acuity Standard Deviation .11
Binocular Uncorrected Defocus Curve. Defocus -1.50	.20 logMAR Acuity Standard Deviation .11
Binocular Uncorrected Defocus Curve. Defocus -1.00	.19 logMAR Acuity Standard Deviation .08
Binocular Uncorrected Defocus Curve. Defocus -0.50	0.09 logMAR Acuity Standard Deviation .10

SECONDARY outcome

Timeframe: 3 months

Quality of vision, measured with a subjective questionnaire (Q of V). Frequency, Severity and "Degree of Bother" aggregate statistics. Scored on a Rasch scale (0-100) where lower is better.

Outcome measures

Outcome measures
Measure	ReSTOR Toric n=29 Participants Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation
Subjective Visual Quality Frequency	32 score on a Rasch scale (0-100) Interval 0.0 to 72.0
Subjective Visual Quality Severity	22 score on a Rasch scale (0-100) Interval 0.0 to 54.0
Subjective Visual Quality Degree of Bother	0 score on a Rasch scale (0-100) Interval 0.0 to 60.0

Adverse Events

ReSTOR Toric

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

Clayton Blehm, MD

Gainesville Eye Associates

Phone: 770-532-4444

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place