Clinical Evaluation of a New Aspheric Intraocular Lens.

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00786565
• Collaborator: (none)
• Enrollment: 75
• Arms: 2
• Duration (Months): 48

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Advanced Akreos Adapt in one operated eye.; Device: Akreos Adapt in fellow operated eye.	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Official Title: Clinical Evaluation of a New Aspheric Intraocular Lens. A Prospective, Multi-Center, Comparative Study.
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Advanced Akreos Adapt Advanced Akreos Adapt Aspheric Intraocular Lens (IOL).	Device: Advanced Akreos Adapt in one operated eye.; Cataract surgery to implant the assigned IOL according to randomized schedule.
Experimental: Akreos Adapt Akreos Adapt Spherical Intraocular Lens (IOL).	Device: Akreos Adapt in fellow operated eye.; Cataract surgery to implant the assigned IOL according to randomized schedule.

Outcome Measures

Primary Outcome Measures

1. Low Contrast Best Corrected Visual Acuity Following Cataract Surgery [3 months]

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

2. Low Contrast Uncorrected Visual Acuity Following Cataract Surgery [3 months]

   Low contrast uncorrected visual acuity 3 months post cataract surgery

3. Photopic Contrast Sensitivity [3 months]

   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)

4. Mesoptic Contrast Sensitivity [3 Months]

   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)

5. Posterior Capsule Opacification Score [24 months]

   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.

Secondary Outcome Measures

1. High Contrast Visual Acuity [1 month]

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

2. High Contrast Visual Acuity Uncorrected [3 months]

3. High Contrast Visual Acuity Best Corrected [3 months]

4. High Contrast Visual Acuity [12 months]

5. High Contrast Visual Acuity Uncorrected [24 Months]

6. High Contrast Visual Acuity Best Corrected [24 Months]

7. Low Contrast Visual Acuity [1 month]

   Uncorrected Low contrast visual acuity - LogMar visual acuity value

8. Contrast Sensitivity Photopic 1.5cpd [1 month]

   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)

9. Contrast Sensitivity Photopic [1 month]

   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)

10. Contrast Sensitivity Mesoptic 1.5 Cpd [1 month]

    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)

11. Contrast Sensitivity Mesoptic [1 month]

    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)

12. Posterior Capsule Opacification [12 months]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00786565
• Other Study ID Numbers: 001/04
• First Posted: Nov 6, 2008
• Last Update Posted: Dec 12, 2011
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Cataract

Study Results

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 Detail	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.

Arm/Group Title	Akreos Intraocular Lens
Arm/Group Description	Subjects randomised to receive Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
Period Title: Enrollment Prior to Surgery
STARTED	75
COMPLETED	69
NOT COMPLETED	6
Period Title: Enrollment Prior to Surgery
STARTED	69
COMPLETED	67
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Akreos Intraocular Lens
Arm/Group Description
Overall Participants	69
Age, Customized (years) [Mean (Standard Deviation) ]
Between 50 and 85 years	73.0 (7.21)
Sex: Female, Male (Count of Participants)
Female	37 53.6%
Male	32 46.4%
Region of Enrollment (participants) [Number]
Europe	69 100%

Outcome Measures

1. Primary Outcome

Title	Low Contrast Best Corrected Visual Acuity Following Cataract Surgery
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	67	67
Mean (Standard Deviation) [LogMAR]	0.22 (0.096)	0.24 (0.131)

2. Primary Outcome

Title	Low Contrast Uncorrected Visual Acuity Following Cataract Surgery
Description	Low contrast uncorrected visual acuity 3 months post cataract surgery
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	68	68
Mean (Standard Deviation) [LogMAR]	0.33 (0.163)	0.35 (0.191)

3. Primary Outcome

Title	Photopic Contrast Sensitivity
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	68	68
Photopic Contrast Sensitivity - 1.5	44.4 (22.5)	41.1 (21.3)
Photopic Contrast Sensitivity - 3.0	78.3 (36.2)	81.1 (38.5)
Photopic Contrast Sensitivity - 6.0	89.6 (48.4)	86.4 (45.5)
Photopic Contrast Sensitivity - 12.0	29.3 (18.3)	26.7 (20.4)
Photopic Contrast Sensitivity - 18.0	11.4 (9.6)	10.1 (10.7)

4. Secondary Outcome

Title	High Contrast Visual Acuity
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	66	66
Uncorrected	0.13 (0.20)	0.18 (0.21)
Best Corrected	0.02 (0.13)	0.05 (0.14)

5. Secondary Outcome

Title	High Contrast Visual Acuity Uncorrected
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	66	67
Mean (Standard Deviation) [LogMAR]	0.15 (0.19)	0.18 (0.22)

6. Secondary Outcome

Title	High Contrast Visual Acuity Best Corrected
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	64	66
Mean (Standard Deviation) [LogMAR]	0.03 (0.12)	0.04 (0.13)

7. Secondary Outcome

Title	High Contrast Visual Acuity
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	60	60
Uncorrected	0.17 (0.19)	0.22 (0.22)
Best Corrected	0.05 (0.13)	0.07 (0.13)

8. Primary Outcome

Title	Mesoptic Contrast Sensitivity
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	68	67
Mesopic Contrast Sensitivity - 1.5	51.2 (27.0)	47.4 (25.4)
Mesopic Contrast Sensitivity - 3.0	65.6 (35.6)	58.1 (35.0)
Mesopic Contrast Sensitivity - 6.0	52.9 (33.5)	45.6 (29.4)
Mesopic Contrast Sensitivity - 12.0	9.5 (10.2)	9.5 (13.0)
Mesopic Contrast Sensitivity - 18.0	2.7 (4.9)	2.0 (3.3)

9. Primary Outcome

Title	Posterior Capsule Opacification Score
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	34	30
PCO Score 3mm	0.05 (0.14)	0.14 (0.24)
PCO Score 6mm	0.12 (0.24)	0.20 (0.31)

10. Secondary Outcome

Title	High Contrast Visual Acuity Uncorrected
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	55	55
Mean (Standard Deviation) [LogMar]	0.22 (0.18)	0.27 (0.23)

11. Secondary Outcome

Title	High Contrast Visual Acuity Best Corrected
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	52	52
Mean (Standard Deviation) [LogMar]	0.11 (0.14)	0.15 (0.19)

12. Secondary Outcome

Title	Low Contrast Visual Acuity
Description	Uncorrected Low contrast visual acuity - LogMar visual acuity value
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	68	68
Uncorrected	0.33 (0.17)	0.36 (0.19)
Best Corrected	0.21 (0.13)	0.24 (0.12)

13. Secondary Outcome

Title	Contrast Sensitivity Photopic 1.5cpd
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	67	67
Mean (Standard Deviation) [Log 10]	39.2 (20.80)	39.9 (20.08)

14. Secondary Outcome

Title	Contrast Sensitivity Photopic
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	66	66
Photopic contrast sensitivity - 3.0	76.6 (36.38)	64.0 (27.83)
Photopic contrast sensitivity - 6.0	92.4 (46.34)	70.5 (39.15)
Photopic contrast sensitivity - 12.0	30.3 (21.46)	22.3 (17.60)
Photopic contrast sensitivity - 18.0	11.0 (9.12)	8.3 (8.90)

15. Secondary Outcome

Title	Contrast Sensitivity Mesoptic 1.5 Cpd
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	67	67
Mean (Standard Deviation) [Log 10]	46.6 (25.21)	40.8 (21.74)

16. Secondary Outcome

Title	Contrast Sensitivity Mesoptic
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	66	66
Mesoptic contrast sensitivity - 3.0	58.2 (28.08)	51.5 (29.57)
Mesoptic contrast sensitivity - 6.0	55.9 (40.56)	39.4 (28.32)
Mesoptic contrast sensitivity - 12.0	9.2 (10.29)	6.7 (10.21)
Mesoptic contrast sensitivity - 18.0	2.8 (4.97)	2.2 (3.84)

17. Secondary Outcome

Title	Posterior Capsule Opacification
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Akreos Advanced Optics	Akreos Adapt
Arm/Group Description	Akreos Advanced Optics Intraocular Lens	Akreos Adapt Intraocular Lens
Measure Participants	40	39
PCO Score - 3mm	0.03 (0.095)	0.06 (0.133)
PCO Score - 6 mm	0.07 (0.148)	0.13 (0.195)

Adverse Events

Time Frame	Ocular adverse events were measured over 24 month study period.
Arm/Group Title	Akreos Advanced Intraocular Lenses		Akreos Adapt Intraocular Lens
Arm/Group Description	Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.		Akreos Advanced Optic Aspheric Intraocular Lens in one eye and Akreos Adapt Spherical Intraocular Lens in the fellow eye.
All Cause Mortality
	Akreos Advanced Intraocular Lenses		Akreos Adapt Intraocular Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Akreos Advanced Intraocular Lenses		Akreos Adapt Intraocular Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/69 (0%)		0/69 (0%)
Other (Not Including Serious) Adverse Events
	Akreos Advanced Intraocular Lenses		Akreos Adapt Intraocular Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/69 (0%)		0/69 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.