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A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)

A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01166971
Enrollment
65
Registered
2010-07-21
Start date
2010-07-31
Completion date
Unknown
Last updated
2011-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

presbyopia, intraocular lens

Brief summary

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.

Interventions

DEVICEReSTOR +3

Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction

DEVICETecnis MF

Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction

Sponsors

Alcon Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* diagnosed with bilateral cataracts * candidate for presbyopic lens

Exclusion criteria

* \>1 Diopter (D) preoperative astigmatism by Keratometry (K)readings * pre-existing conditions that could skew the results

Design outcomes

Primary

MeasureTime frameDescription
Defocus Curve3 months after surgeryA defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution.

Countries

United States

Participant flow

Recruitment details

Bilateral diagnosis of cataracts of subjects \>21 years of age

Pre-assignment details

During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.

Participants by arm

ArmCount
ReSTOR +3
Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
33
Tecnis MF
Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
31
Total64

Baseline characteristics

CharacteristicReSTOR +3Tecnis MFTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
14 Participants21 Participants35 Participants
Age, Categorical
Between 18 and 65 years
19 Participants10 Participants29 Participants
Sex: Female, Male
Female
18 Participants20 Participants38 Participants
Sex: Female, Male
Male
15 Participants11 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 320 / 30
serious
Total, serious adverse events
0 / 320 / 30

Outcome results

Primary

Defocus Curve

A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution.

Time frame: 3 months after surgery

Population: In the ReSTOR +3 population, 1 subject did not complete the assessment at -5.00 D; therefore, only 32 subjects were used for this measure.

ArmMeasureGroupValue (MEAN)Dispersion
ReSTOR +3Defocus Curve-3.00 D0.126 LogMARStandard Deviation 0.185
ReSTOR +3Defocus Curve-1.00 D0.212 LogMARStandard Deviation 0.144
ReSTOR +3Defocus Curve-4.50 D0.490 LogMARStandard Deviation 0.204
ReSTOR +3Defocus Curve-0.50 D0.052 LogMARStandard Deviation 0.132
ReSTOR +3Defocus Curve-2.50 D0.017 LogMARStandard Deviation 0.144
ReSTOR +3Defocus Curve0.00 D-0.048 LogMARStandard Deviation 0.097
ReSTOR +3Defocus Curve-3.50 D0.261 LogMARStandard Deviation 0.183
ReSTOR +3Defocus Curve0.50 D0.035 LogMARStandard Deviation 0.112
ReSTOR +3Defocus Curve-2.00 D0.055 LogMARStandard Deviation 0.147
ReSTOR +3Defocus Curve1.00 D0.258 LogMARStandard Deviation 0.14
ReSTOR +3Defocus Curve-4.00 D0.388 LogMARStandard Deviation 0.189
ReSTOR +3Defocus Curve1.50 D0.434 LogMARStandard Deviation 0.153
ReSTOR +3Defocus Curve-1.50 D0.245 LogMARStandard Deviation 0.175
ReSTOR +3Defocus Curve2.00 D0.539 LogMARStandard Deviation 0.168
ReSTOR +3Defocus Curve-5.00 Diopter (D)0.585 LogMARStandard Deviation 0.204
Tecnis MFDefocus Curve2.00 D0.446 LogMARStandard Deviation 0.136
Tecnis MFDefocus Curve-5.00 Diopter (D)0.653 LogMARStandard Deviation 0.116
Tecnis MFDefocus Curve-4.50 D0.475 LogMARStandard Deviation 0.115
Tecnis MFDefocus Curve-4.00 D0.337 LogMARStandard Deviation 0.107
Tecnis MFDefocus Curve-3.50 D0.168 LogMARStandard Deviation 0.114
Tecnis MFDefocus Curve-3.00 D0.046 LogMARStandard Deviation 0.104
Tecnis MFDefocus Curve-2.50 D0.073 LogMARStandard Deviation 0.113
Tecnis MFDefocus Curve-2.00 D0.222 LogMARStandard Deviation 0.178
Tecnis MFDefocus Curve-1.50 D0.326 LogMARStandard Deviation 0.12
Tecnis MFDefocus Curve-1.00 D0.225 LogMARStandard Deviation 0.128
Tecnis MFDefocus Curve-0.50 D0.072 LogMARStandard Deviation 0.12
Tecnis MFDefocus Curve0.00 D-0.044 LogMARStandard Deviation 0.085
Tecnis MFDefocus Curve0.50 D0.032 LogMARStandard Deviation 0.111
Tecnis MFDefocus Curve1.00 D0.237 LogMARStandard Deviation 0.2
Tecnis MFDefocus Curve1.50 D0.364 LogMARStandard Deviation 0.176

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026