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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
NCT00963560
Enrollment
132
Registered
2009-08-21
Start date
2009-08-31
Completion date
Unknown
Last updated
2011-08-09

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

Conditions

Cataract

Keywords

ReSTOR +3

Brief summary

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).

Interventions

DEVICEReSTOR +3

Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract.

DEVICECrystalens HD

Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract.

DEVICECrystalens AO

Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract.

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 preoperative astigmatism by Keratometry readings * pre-existing conditions that could skew the results

Design outcomes

Primary

MeasureTime frameDescription
Best Corrected Visual Acuity6 Months after surgeryBest corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.

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 Lens (IOL)
47
Crystalens HD
Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
44
Crystalens AO
Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
41
Total132

Baseline characteristics

CharacteristicReSTOR +3Crystalens HDCrystalens AOTotal
Age Continuous63.4 years
STANDARD_DEVIATION 9.4
64 years
STANDARD_DEVIATION 7.8
65.3 years
STANDARD_DEVIATION 7.5
64.23 years
STANDARD_DEVIATION 8.23
Sex: Female, Male
Female
28 Participants25 Participants26 Participants79 Participants
Sex: Female, Male
Male
19 Participants19 Participants15 Participants53 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 470 / 440 / 41
serious
Total, serious adverse events
0 / 470 / 440 / 41

Outcome results

Primary

Best Corrected Visual Acuity

Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.

Time frame: 6 Months after surgery

Population: 2 ReSTOR +3 subjects and 1 Crystalens HD subject missed their final visits and were not included in this analysis.

ArmMeasureGroupValue (MEAN)Dispersion
ReSTOR +3Best Corrected Visual AcuityPreferred Distance0.055 logMARStandard Deviation 0.121
ReSTOR +3Best Corrected Visual Acuity60cm (intermediate) Distance0.227 logMARStandard Deviation 0.119
ReSTOR +3Best Corrected Visual Acuity4m (far) Distance-0.075 logMARStandard Deviation 0.1
ReSTOR +3Best Corrected Visual Acuity40 cm (near) Distance0.057 logMARStandard Deviation 0.086
Crystalens HDBest Corrected Visual Acuity60cm (intermediate) Distance0.176 logMARStandard Deviation 0.139
Crystalens HDBest Corrected Visual Acuity4m (far) Distance-0.080 logMARStandard Deviation 0.103
Crystalens HDBest Corrected Visual Acuity40 cm (near) Distance0.364 logMARStandard Deviation 0.183
Crystalens HDBest Corrected Visual AcuityPreferred Distance0.223 logMARStandard Deviation 0.146
Crystalens AOBest Corrected Visual Acuity40 cm (near) Distance0.420 logMARStandard Deviation 0.188
Crystalens AOBest Corrected Visual Acuity4m (far) Distance-0.081 logMARStandard Deviation 0.11
Crystalens AOBest Corrected Visual AcuityPreferred Distance0.222 logMARStandard Deviation 0.138
Crystalens AOBest Corrected Visual Acuity60cm (intermediate) Distance0.200 logMARStandard Deviation 0.154

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