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Clinical Evaluation of a New Aspheric Intraocular Lens.

Clinical Evaluation of a New Aspheric Intraocular Lens. A Prospective, Multi-Center, Comparative Study.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00786565
Enrollment
75
Registered
2008-11-06
Start date
2004-01-31
Completion date
2008-01-31
Last updated
2011-12-12

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

Conditions

Cataract

Brief summary

This study evaluates the visual performance and occurrence of posterior capsular opacification after implantation of a new aspherical intraocular lens compared with a control spherical lens of otherwise identical design.

Interventions

DEVICEAdvanced Akreos Adapt in one operated eye.

Cataract surgery to implant the assigned IOL according to randomized schedule.

DEVICEAkreos Adapt in fellow operated eye.

Cataract surgery to implant the assigned IOL according to randomized schedule.

Sponsors

Bausch & Lomb Incorporated
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Patients must have a clinically documented diagnosis of bilateral cataract (either cortical, nuclear, subcapsular or a combination) liable to benefit from standard cataract surgery. * Patients must be undergoing primary cataract surgery with IOL in-the-bag implantation, requiring a IOL power from 10 to 30 diopters.

Exclusion criteria

* Patients with corneal damage. * Patients with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated. * Patients with any ocular pathology, other than the cataract, having repercussions on visual function:

Design outcomes

Primary

MeasureTime frameDescription
Low Contrast Best Corrected Visual Acuity Following Cataract Surgery3 monthsLow contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery.
Low Contrast Uncorrected Visual Acuity Following Cataract Surgery3 monthsLow contrast uncorrected visual acuity 3 months post cataract surgery
Photopic Contrast Sensitivity3 monthsThe mean photopic (day light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)
Mesoptic Contrast Sensitivity3 MonthsThe mean mesoptic (low light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)
Posterior Capsule Opacification Score24 monthsPosterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.

Secondary

MeasureTime frameDescription
Contrast Sensitivity Photopic1 monthThe mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)
Contrast Sensitivity Mesoptic 1.5 Cpd1 monthThe mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)
High Contrast Visual Acuity Best Corrected3 months—
Posterior Capsule Opacification12 monthsPosterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.
Contrast Sensitivity Mesoptic1 monthThe mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)
High Contrast Visual Acuity1 monthHigh contrast visual acuity (ability to distinguish objects of contrasting color such as black on white) uncorrected and best corrected visual acuity.
High Contrast Visual Acuity Uncorrected3 months—
Low Contrast Visual Acuity1 monthUncorrected Low contrast visual acuity - LogMar visual acuity value
Contrast Sensitivity Photopic 1.5cpd1 monthThe mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)

Participant flow

Recruitment details

Recruitment began on 12/15/2004 and ended on 04/28/2006. This study was conducted at 5 European sites.

Pre-assignment details

Planned enrollment was to consist of 120 subjects, due to difficulties in enrolling subjects within the designated 6 month enrollment window 75 subjects were entered into the study for a total of 150 treated eyes.

Participants by arm

ArmCount
Akreos Intraocular Lens69
Total69

Withdrawals & dropouts

PeriodReasonFG000
Enrollment Prior to SurgeryProtocol Violation3
Enrollment Prior to SurgerySite Closed3
Post SurgeryAbnormal macular pucker1
Post SurgeryAdapt AO implanted posterior side up1

Baseline characteristics

CharacteristicAkreos Intraocular Lens
Age, Customized
Between 50 and 85 years
73.0 years
STANDARD_DEVIATION 7.21
Region of Enrollment
Europe
69 participants
Sex: Female, Male
Female
37 Participants
Sex: Female, Male
Male
32 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 690 / 69
serious
Total, serious adverse events
0 / 690 / 69

Outcome results

Primary

Low Contrast Best Corrected Visual Acuity Following Cataract Surgery

Low contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery.

Time frame: 3 months

Population: Number of participants 67 total with 67 eyes in each group, full analysis set, all randomized participants who had cataract surgery one intraocular lens (IOL) in each eye, and who had at least one baseline value and one post-baseline value for efficacy.

ArmMeasureValue (MEAN)Dispersion
Akreos Advanced OpticsLow Contrast Best Corrected Visual Acuity Following Cataract Surgery0.22 LogMARStandard Deviation 0.096
Akreos AdaptLow Contrast Best Corrected Visual Acuity Following Cataract Surgery0.24 LogMARStandard Deviation 0.131
Primary

Low Contrast Uncorrected Visual Acuity Following Cataract Surgery

Low contrast uncorrected visual acuity 3 months post cataract surgery

Time frame: 3 months

Population: Full analysis set, all randomized participants who had cataract surgery one intraocular lens (IOL) in each eye, and who had at least one baseline value and one post-baseline value for efficacy

ArmMeasureValue (MEAN)Dispersion
Akreos Advanced OpticsLow Contrast Uncorrected Visual Acuity Following Cataract Surgery0.33 LogMARStandard Deviation 0.163
Akreos AdaptLow Contrast Uncorrected Visual Acuity Following Cataract Surgery0.35 LogMARStandard Deviation 0.191
Primary

Mesoptic Contrast Sensitivity

The mean mesoptic (low light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)

Time frame: 3 Months

Population: All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.

ArmMeasureGroupValue (MEAN)Dispersion
Akreos Advanced OpticsMesoptic Contrast SensitivityMesopic Contrast Sensitivity - 3.065.6 Log 10Standard Deviation 35.6
Akreos Advanced OpticsMesoptic Contrast SensitivityMesopic Contrast Sensitivity - 12.09.5 Log 10Standard Deviation 10.2
Akreos Advanced OpticsMesoptic Contrast SensitivityMesopic Contrast Sensitivity - 6.052.9 Log 10Standard Deviation 33.5
Akreos Advanced OpticsMesoptic Contrast SensitivityMesopic Contrast Sensitivity - 18.02.7 Log 10Standard Deviation 4.9
Akreos Advanced OpticsMesoptic Contrast SensitivityMesopic Contrast Sensitivity - 1.551.2 Log 10Standard Deviation 27
Akreos AdaptMesoptic Contrast SensitivityMesopic Contrast Sensitivity - 18.02.0 Log 10Standard Deviation 3.3
Akreos AdaptMesoptic Contrast SensitivityMesopic Contrast Sensitivity - 1.547.4 Log 10Standard Deviation 25.4
Akreos AdaptMesoptic Contrast SensitivityMesopic Contrast Sensitivity - 3.058.1 Log 10Standard Deviation 35
Akreos AdaptMesoptic Contrast SensitivityMesopic Contrast Sensitivity - 6.045.6 Log 10Standard Deviation 29.4
Akreos AdaptMesoptic Contrast SensitivityMesopic Contrast Sensitivity - 12.09.5 Log 10Standard Deviation 13
Primary

Photopic Contrast Sensitivity

The mean photopic (day light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)

Time frame: 3 months

Population: All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.

ArmMeasureGroupValue (MEAN)Dispersion
Akreos Advanced OpticsPhotopic Contrast SensitivityPhotopic Contrast Sensitivity - 1.544.4 Log 10Standard Deviation 22.5
Akreos Advanced OpticsPhotopic Contrast SensitivityPhotopic Contrast Sensitivity - 6.089.6 Log 10Standard Deviation 48.4
Akreos Advanced OpticsPhotopic Contrast SensitivityPhotopic Contrast Sensitivity - 3.078.3 Log 10Standard Deviation 36.2
Akreos Advanced OpticsPhotopic Contrast SensitivityPhotopic Contrast Sensitivity - 12.029.3 Log 10Standard Deviation 18.3
Akreos Advanced OpticsPhotopic Contrast SensitivityPhotopic Contrast Sensitivity - 18.011.4 Log 10Standard Deviation 9.6
Akreos AdaptPhotopic Contrast SensitivityPhotopic Contrast Sensitivity - 12.026.7 Log 10Standard Deviation 20.4
Akreos AdaptPhotopic Contrast SensitivityPhotopic Contrast Sensitivity - 18.010.1 Log 10Standard Deviation 10.7
Akreos AdaptPhotopic Contrast SensitivityPhotopic Contrast Sensitivity - 1.541.1 Log 10Standard Deviation 21.3
Akreos AdaptPhotopic Contrast SensitivityPhotopic Contrast Sensitivity - 3.081.1 Log 10Standard Deviation 38.5
Akreos AdaptPhotopic Contrast SensitivityPhotopic Contrast Sensitivity - 6.086.4 Log 10Standard Deviation 45.5
Primary

Posterior Capsule Opacification Score

Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.

Time frame: 24 months

Population: The EPCO score, evaluated by an independent observer using retro-illumination pictures, all pictures available. Measured in a 3mm and 6mm optic area.

ArmMeasureGroupValue (MEAN)Dispersion
Akreos Advanced OpticsPosterior Capsule Opacification ScorePCO Score 3mm0.05 EPCO ScoreStandard Deviation 0.14
Akreos Advanced OpticsPosterior Capsule Opacification ScorePCO Score 6mm0.12 EPCO ScoreStandard Deviation 0.24
Akreos AdaptPosterior Capsule Opacification ScorePCO Score 3mm0.14 EPCO ScoreStandard Deviation 0.24
Akreos AdaptPosterior Capsule Opacification ScorePCO Score 6mm0.20 EPCO ScoreStandard Deviation 0.31
Secondary

Contrast Sensitivity Mesoptic

The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)

Time frame: 1 month

Population: All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.

ArmMeasureGroupValue (MEAN)Dispersion
Akreos Advanced OpticsContrast Sensitivity MesopticMesoptic contrast sensitivity - 3.058.2 Log 10Standard Deviation 28.08
Akreos Advanced OpticsContrast Sensitivity MesopticMesoptic contrast sensitivity - 6.055.9 Log 10Standard Deviation 40.56
Akreos Advanced OpticsContrast Sensitivity MesopticMesoptic contrast sensitivity - 12.09.2 Log 10Standard Deviation 10.29
Akreos Advanced OpticsContrast Sensitivity MesopticMesoptic contrast sensitivity - 18.02.8 Log 10Standard Deviation 4.97
Akreos AdaptContrast Sensitivity MesopticMesoptic contrast sensitivity - 18.02.2 Log 10Standard Deviation 3.84
Akreos AdaptContrast Sensitivity MesopticMesoptic contrast sensitivity - 3.051.5 Log 10Standard Deviation 29.57
Akreos AdaptContrast Sensitivity MesopticMesoptic contrast sensitivity - 12.06.7 Log 10Standard Deviation 10.21
Akreos AdaptContrast Sensitivity MesopticMesoptic contrast sensitivity - 6.039.4 Log 10Standard Deviation 28.32
Secondary

Contrast Sensitivity Mesoptic 1.5 Cpd

The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)

Time frame: 1 month

Population: All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.

ArmMeasureValue (MEAN)Dispersion
Akreos Advanced OpticsContrast Sensitivity Mesoptic 1.5 Cpd46.6 Log 10Standard Deviation 25.21
Akreos AdaptContrast Sensitivity Mesoptic 1.5 Cpd40.8 Log 10Standard Deviation 21.74
Secondary

Contrast Sensitivity Photopic

The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)

Time frame: 1 month

Population: All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.

ArmMeasureGroupValue (MEAN)Dispersion
Akreos Advanced OpticsContrast Sensitivity PhotopicPhotopic contrast sensitivity - 3.076.6 Log 10Standard Deviation 36.38
Akreos Advanced OpticsContrast Sensitivity PhotopicPhotopic contrast sensitivity - 6.092.4 Log 10Standard Deviation 46.34
Akreos Advanced OpticsContrast Sensitivity PhotopicPhotopic contrast sensitivity - 12.030.3 Log 10Standard Deviation 21.46
Akreos Advanced OpticsContrast Sensitivity PhotopicPhotopic contrast sensitivity - 18.011.0 Log 10Standard Deviation 9.12
Akreos AdaptContrast Sensitivity PhotopicPhotopic contrast sensitivity - 18.08.3 Log 10Standard Deviation 8.9
Akreos AdaptContrast Sensitivity PhotopicPhotopic contrast sensitivity - 3.064.0 Log 10Standard Deviation 27.83
Akreos AdaptContrast Sensitivity PhotopicPhotopic contrast sensitivity - 12.022.3 Log 10Standard Deviation 17.6
Akreos AdaptContrast Sensitivity PhotopicPhotopic contrast sensitivity - 6.070.5 Log 10Standard Deviation 39.15
Secondary

Contrast Sensitivity Photopic 1.5cpd

The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)

Time frame: 1 month

Population: All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.

ArmMeasureValue (MEAN)Dispersion
Akreos Advanced OpticsContrast Sensitivity Photopic 1.5cpd39.2 Log 10Standard Deviation 20.8
Akreos AdaptContrast Sensitivity Photopic 1.5cpd39.9 Log 10Standard Deviation 20.08
Secondary

High Contrast Visual Acuity

Time frame: 12 months

Population: Patients without missing values for HCVA logmar at pre-operative and post operative at 1 month control.

ArmMeasureGroupValue (MEAN)Dispersion
Akreos Advanced OpticsHigh Contrast Visual AcuityUncorrected0.17 LogMARStandard Deviation 0.19
Akreos Advanced OpticsHigh Contrast Visual AcuityBest Corrected0.05 LogMARStandard Deviation 0.13
Akreos AdaptHigh Contrast Visual AcuityUncorrected0.22 LogMARStandard Deviation 0.22
Akreos AdaptHigh Contrast Visual AcuityBest Corrected0.07 LogMARStandard Deviation 0.13
Secondary

High Contrast Visual Acuity

High contrast visual acuity (ability to distinguish objects of contrasting color such as black on white) uncorrected and best corrected visual acuity.

Time frame: 1 month

Population: Patients without missing values for HCVA logmar at pre-operative and post operative at 1 month control.

ArmMeasureGroupValue (MEAN)Dispersion
Akreos Advanced OpticsHigh Contrast Visual AcuityUncorrected0.13 LogMARStandard Deviation 0.2
Akreos Advanced OpticsHigh Contrast Visual AcuityBest Corrected0.02 LogMARStandard Deviation 0.13
Akreos AdaptHigh Contrast Visual AcuityUncorrected0.18 LogMARStandard Deviation 0.21
Akreos AdaptHigh Contrast Visual AcuityBest Corrected0.05 LogMARStandard Deviation 0.14
Secondary

High Contrast Visual Acuity Best Corrected

Time frame: 3 months

Population: Patients without missing values for BHCVA logmar at pre-operative and post operative at 1 month control.

ArmMeasureValue (MEAN)Dispersion
Akreos Advanced OpticsHigh Contrast Visual Acuity Best Corrected0.03 LogMARStandard Deviation 0.12
Akreos AdaptHigh Contrast Visual Acuity Best Corrected0.04 LogMARStandard Deviation 0.13
Secondary

High Contrast Visual Acuity Best Corrected

Time frame: 24 Months

Population: Patients without missing values for best corrected HCVA logmar at pre-operative and post operative at 1 month control.

ArmMeasureValue (MEAN)Dispersion
Akreos Advanced OpticsHigh Contrast Visual Acuity Best Corrected0.11 LogMarStandard Deviation 0.14
Akreos AdaptHigh Contrast Visual Acuity Best Corrected0.15 LogMarStandard Deviation 0.19
Secondary

High Contrast Visual Acuity Uncorrected

Time frame: 3 months

Population: Patients without missing values for UHCVA logmar at pre-operative and post operative at 1 month control.

ArmMeasureValue (MEAN)Dispersion
Akreos Advanced OpticsHigh Contrast Visual Acuity Uncorrected0.15 LogMARStandard Deviation 0.19
Akreos AdaptHigh Contrast Visual Acuity Uncorrected0.18 LogMARStandard Deviation 0.22
Secondary

High Contrast Visual Acuity Uncorrected

Time frame: 24 Months

Population: Patients without missing values for UHCVA logmar at pre-operative and post operative at 1 month control.

ArmMeasureValue (MEAN)Dispersion
Akreos Advanced OpticsHigh Contrast Visual Acuity Uncorrected0.22 LogMarStandard Deviation 0.18
Akreos AdaptHigh Contrast Visual Acuity Uncorrected0.27 LogMarStandard Deviation 0.23
Secondary

Low Contrast Visual Acuity

Uncorrected Low contrast visual acuity - LogMar visual acuity value

Time frame: 1 month

Population: All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.

ArmMeasureGroupValue (MEAN)Dispersion
Akreos Advanced OpticsLow Contrast Visual AcuityUncorrected0.33 LogMarStandard Deviation 0.17
Akreos Advanced OpticsLow Contrast Visual AcuityBest Corrected0.21 LogMarStandard Deviation 0.13
Akreos AdaptLow Contrast Visual AcuityUncorrected0.36 LogMarStandard Deviation 0.19
Akreos AdaptLow Contrast Visual AcuityBest Corrected0.24 LogMarStandard Deviation 0.12
Secondary

Posterior Capsule Opacification

Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.

Time frame: 12 months

Population: The EPCO score, evaluated by an independent observer using retro-illumination pictures, all pictures available. Measured in a 3mm and 6mm optic area.

ArmMeasureGroupValue (MEAN)Dispersion
Akreos Advanced OpticsPosterior Capsule OpacificationPCO Score - 6 mm0.07 EPCO ScoreStandard Deviation 0.148
Akreos Advanced OpticsPosterior Capsule OpacificationPCO Score - 3mm0.03 EPCO ScoreStandard Deviation 0.095
Akreos AdaptPosterior Capsule OpacificationPCO Score - 3mm0.06 EPCO ScoreStandard Deviation 0.133
Akreos AdaptPosterior Capsule OpacificationPCO Score - 6 mm0.13 EPCO ScoreStandard Deviation 0.195

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