Trial Outcomes & Findings for Clinical Evaluation of a New Aspheric Intraocular Lens. (NCT NCT00786565)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

75 participants

Primary outcome timeframe

3 months

Results posted on

2011-12-12

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	Akreos Intraocular Lens Subjects randomised to receive Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
Enrollment Prior to Surgery STARTED	75
Enrollment Prior to Surgery COMPLETED	69
Enrollment Prior to Surgery NOT COMPLETED	6
Post Surgery STARTED	69
Post Surgery COMPLETED	67
Post Surgery NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Akreos Intraocular Lens Subjects randomised to receive Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
Enrollment Prior to Surgery Site Closed	3
Enrollment Prior to Surgery Protocol Violation	3
Post Surgery Abnormal macular pucker	1
Post Surgery Adapt AO implanted posterior side up	1

Baseline Characteristics

Clinical Evaluation of a New Aspheric Intraocular Lens.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Akreos Intraocular Lens n=69 Participants
Age, Customized Between 50 and 85 years	73.0 years STANDARD_DEVIATION 7.21 • n=93 Participants
Sex: Female, Male Female	37 Participants n=93 Participants
Sex: Female, Male Male	32 Participants n=93 Participants
Region of Enrollment Europe	69 participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=67 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=67 Participants Akreos Adapt Intraocular Lens
Low Contrast Best Corrected Visual Acuity Following Cataract Surgery	0.22 LogMAR Standard Deviation 0.096	0.24 LogMAR Standard Deviation 0.131

PRIMARY outcome

Timeframe: 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

Low contrast uncorrected visual acuity 3 months post cataract surgery

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=68 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=68 Participants Akreos Adapt Intraocular Lens
Low Contrast Uncorrected Visual Acuity Following Cataract Surgery	0.33 LogMAR Standard Deviation 0.163	0.35 LogMAR Standard Deviation 0.191

PRIMARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=68 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=68 Participants Akreos Adapt Intraocular Lens
Photopic Contrast Sensitivity Photopic Contrast Sensitivity - 1.5	44.4 Log 10 Standard Deviation 22.5	41.1 Log 10 Standard Deviation 21.3
Photopic Contrast Sensitivity Photopic Contrast Sensitivity - 3.0	78.3 Log 10 Standard Deviation 36.2	81.1 Log 10 Standard Deviation 38.5
Photopic Contrast Sensitivity Photopic Contrast Sensitivity - 6.0	89.6 Log 10 Standard Deviation 48.4	86.4 Log 10 Standard Deviation 45.5
Photopic Contrast Sensitivity Photopic Contrast Sensitivity - 12.0	29.3 Log 10 Standard Deviation 18.3	26.7 Log 10 Standard Deviation 20.4
Photopic Contrast Sensitivity Photopic Contrast Sensitivity - 18.0	11.4 Log 10 Standard Deviation 9.6	10.1 Log 10 Standard Deviation 10.7

PRIMARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=68 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=67 Participants Akreos Adapt Intraocular Lens
Mesoptic Contrast Sensitivity Mesopic Contrast Sensitivity - 1.5	51.2 Log 10 Standard Deviation 27.0	47.4 Log 10 Standard Deviation 25.4
Mesoptic Contrast Sensitivity Mesopic Contrast Sensitivity - 3.0	65.6 Log 10 Standard Deviation 35.6	58.1 Log 10 Standard Deviation 35.0
Mesoptic Contrast Sensitivity Mesopic Contrast Sensitivity - 6.0	52.9 Log 10 Standard Deviation 33.5	45.6 Log 10 Standard Deviation 29.4
Mesoptic Contrast Sensitivity Mesopic Contrast Sensitivity - 12.0	9.5 Log 10 Standard Deviation 10.2	9.5 Log 10 Standard Deviation 13.0
Mesoptic Contrast Sensitivity Mesopic Contrast Sensitivity - 18.0	2.7 Log 10 Standard Deviation 4.9	2.0 Log 10 Standard Deviation 3.3

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=34 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=30 Participants Akreos Adapt Intraocular Lens
Posterior Capsule Opacification Score PCO Score 3mm	0.05 EPCO Score Standard Deviation 0.14	0.14 EPCO Score Standard Deviation 0.24
Posterior Capsule Opacification Score PCO Score 6mm	0.12 EPCO Score Standard Deviation 0.24	0.20 EPCO Score Standard Deviation 0.31

SECONDARY outcome

Timeframe: 1 month

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

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

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=66 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=66 Participants Akreos Adapt Intraocular Lens
High Contrast Visual Acuity Uncorrected	0.13 LogMAR Standard Deviation 0.20	0.18 LogMAR Standard Deviation 0.21
High Contrast Visual Acuity Best Corrected	0.02 LogMAR Standard Deviation 0.13	0.05 LogMAR Standard Deviation 0.14

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=66 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=67 Participants Akreos Adapt Intraocular Lens
High Contrast Visual Acuity Uncorrected	0.15 LogMAR Standard Deviation 0.19	0.18 LogMAR Standard Deviation 0.22

SECONDARY outcome

Timeframe: 3 months

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

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=64 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=66 Participants Akreos Adapt Intraocular Lens
High Contrast Visual Acuity Best Corrected	0.03 LogMAR Standard Deviation 0.12	0.04 LogMAR Standard Deviation 0.13

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=60 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=60 Participants Akreos Adapt Intraocular Lens
High Contrast Visual Acuity Uncorrected	0.17 LogMAR Standard Deviation 0.19	0.22 LogMAR Standard Deviation 0.22
High Contrast Visual Acuity Best Corrected	0.05 LogMAR Standard Deviation 0.13	0.07 LogMAR Standard Deviation 0.13

SECONDARY outcome

Timeframe: 24 Months

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

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=55 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=55 Participants Akreos Adapt Intraocular Lens
High Contrast Visual Acuity Uncorrected	0.22 LogMar Standard Deviation 0.18	0.27 LogMar Standard Deviation 0.23

SECONDARY outcome

Timeframe: 24 Months

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

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=52 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=52 Participants Akreos Adapt Intraocular Lens
High Contrast Visual Acuity Best Corrected	0.11 LogMar Standard Deviation 0.14	0.15 LogMar Standard Deviation 0.19

SECONDARY outcome

Timeframe: 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.

Uncorrected Low contrast visual acuity - LogMar visual acuity value

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=68 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=68 Participants Akreos Adapt Intraocular Lens
Low Contrast Visual Acuity Uncorrected	0.33 LogMar Standard Deviation 0.17	0.36 LogMar Standard Deviation 0.19
Low Contrast Visual Acuity Best Corrected	0.21 LogMar Standard Deviation 0.13	0.24 LogMar Standard Deviation 0.12

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=67 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=67 Participants Akreos Adapt Intraocular Lens
Contrast Sensitivity Photopic 1.5cpd	39.2 Log 10 Standard Deviation 20.80	39.9 Log 10 Standard Deviation 20.08

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=66 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=66 Participants Akreos Adapt Intraocular Lens
Contrast Sensitivity Photopic Photopic contrast sensitivity - 3.0	76.6 Log 10 Standard Deviation 36.38	64.0 Log 10 Standard Deviation 27.83
Contrast Sensitivity Photopic Photopic contrast sensitivity - 6.0	92.4 Log 10 Standard Deviation 46.34	70.5 Log 10 Standard Deviation 39.15
Contrast Sensitivity Photopic Photopic contrast sensitivity - 12.0	30.3 Log 10 Standard Deviation 21.46	22.3 Log 10 Standard Deviation 17.60
Contrast Sensitivity Photopic Photopic contrast sensitivity - 18.0	11.0 Log 10 Standard Deviation 9.12	8.3 Log 10 Standard Deviation 8.90

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=67 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=67 Participants Akreos Adapt Intraocular Lens
Contrast Sensitivity Mesoptic 1.5 Cpd	46.6 Log 10 Standard Deviation 25.21	40.8 Log 10 Standard Deviation 21.74

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=66 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=66 Participants Akreos Adapt Intraocular Lens
Contrast Sensitivity Mesoptic Mesoptic contrast sensitivity - 3.0	58.2 Log 10 Standard Deviation 28.08	51.5 Log 10 Standard Deviation 29.57
Contrast Sensitivity Mesoptic Mesoptic contrast sensitivity - 6.0	55.9 Log 10 Standard Deviation 40.56	39.4 Log 10 Standard Deviation 28.32
Contrast Sensitivity Mesoptic Mesoptic contrast sensitivity - 12.0	9.2 Log 10 Standard Deviation 10.29	6.7 Log 10 Standard Deviation 10.21
Contrast Sensitivity Mesoptic Mesoptic contrast sensitivity - 18.0	2.8 Log 10 Standard Deviation 4.97	2.2 Log 10 Standard Deviation 3.84

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Akreos Advanced Optics n=40 Participants Akreos Advanced Optics Intraocular Lens	Akreos Adapt n=39 Participants Akreos Adapt Intraocular Lens
Posterior Capsule Opacification PCO Score - 3mm	0.03 EPCO Score Standard Deviation 0.095	0.06 EPCO Score Standard Deviation 0.133
Posterior Capsule Opacification PCO Score - 6 mm	0.07 EPCO Score Standard Deviation 0.148	0.13 EPCO Score Standard Deviation 0.195

Adverse Events

Akreos Advanced Intraocular Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Akreos Adapt Intraocular Lens

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

Jon Hayashida

Bausch & Lomb

Phone: (585) 338-6370

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60