CataractPhase 4NCT00786565

Clinical Evaluation of a New Aspheric Intraocular Lens.

A Phase 4 study testing Advanced Akreos Adapt in one operated eye. and Akreos Adapt in fellow operated eye. in people with Cataract, run by Bausch & Lomb Incorporated.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 to 85 years
Conditions the study is for: Cataract
What is being tested?: Advanced Akreos Adapt in one operated eye. and Akreos Adapt in fellow operated eye.
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: No sites listed yet
Study dates: Jan 2004to Jan 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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:

About this study

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

Conditions: Cataract
Being tested: Advanced Akreos Adapt in one operated eye., Akreos Adapt in fellow operated eye.
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Advanced Akreos Adapt in one operated eye.Device
Cataract surgery to implant the assigned IOL according to randomized schedule.
Akreos Adapt in fellow operated eye.Device
Cataract surgery to implant the assigned IOL according to randomized schedule.

Study groups in NCT00786565
Study group	Role	What they receive
Advanced Akreos Adapt	Experimental	Advanced Akreos Adapt Aspheric Intraocular Lens (IOL). Receives: Device: Advanced Akreos Adapt in one operated eye.
Akreos Adapt	Experimental	Akreos Adapt Spherical Intraocular Lens (IOL). Receives: Device: Akreos Adapt in fellow operated eye.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months
Low Contrast Uncorrected Visual Acuity Following Cataract Surgery
Low contrast uncorrected visual acuity 3 months post cataract surgery
Measured: 3 months
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)
Measured: 3 months
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)
Measured: 3 Months
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.
Measured: 24 months

Secondary outcomes (12)

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.
Measured: 1 month
High Contrast Visual Acuity Uncorrected
Measured: 3 months
High Contrast Visual Acuity Best Corrected
Measured: 3 months
High Contrast Visual Acuity
Measured: 12 months
High Contrast Visual Acuity Uncorrected
Measured: 24 Months
High Contrast Visual Acuity Best Corrected
Measured: 24 Months
Low Contrast Visual Acuity
Uncorrected Low contrast visual acuity - LogMar visual acuity value
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2004Jan 2008

First posted6 Nov 2008 (estimated)
Study startJan 2004
Primary completionJan 2008
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00786565
Sponsor's protocol ID: 001/04
Status last verified: Dec 2011
First submitted: 3 Nov 2008
Last updated: 12 Dec 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of a New Aspheric Intraocular Lens. A Prospective, Multi-Center, Comparative Study.
ClinicalTrials.gov ID: NCT00786565
Acronym / sponsor ID: 001/04
Conditions: Cataract
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Jan 2004
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 6 Nov 2008 (estimated)
Results: Posted 5 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Advanced Akreos Adapt	Experimental	Device: Advanced Akreos Adapt in one operated eye.Advanced Akreos Adapt Aspheric Intraocular Lens (IOL).
Akreos Adapt	Experimental	Device: Akreos Adapt in fellow operated eye.Akreos Adapt Spherical Intraocular Lens (IOL).

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Advanced Akreos Adapt in one operated eye.Cataract surgery to implant the assigned IOL according to randomized schedule.	Device	Advanced Akreos Adapt
Akreos Adapt in fellow operated eye.Cataract surgery to implant the assigned IOL according to randomized schedule.	Device	Akreos Adapt

Primary outcome

Low Contrast Best Corrected Visual Acuity Following Cataract Surgery
Time frame: 3 months
Low 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 Surgery
Time frame: 3 months
Low contrast uncorrected visual acuity 3 months post cataract surgery
Photopic Contrast Sensitivity
Time frame: 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)
Mesoptic Contrast Sensitivity
Time frame: 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)
Posterior Capsule Opacification Score
Time frame: 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.

12 secondary outcomes

High Contrast Visual Acuity
Time frame: 1 month
High Contrast Visual Acuity Uncorrected
Time frame: 3 months
High Contrast Visual Acuity Best Corrected
Time frame: 3 months
High Contrast Visual Acuity
Time frame: 12 months
High Contrast Visual Acuity Uncorrected
Time frame: 24 Months
High Contrast Visual Acuity Best Corrected
Time frame: 24 Months
Low Contrast Visual Acuity
Time frame: 1 month
Contrast Sensitivity Photopic 1.5cpd
Time frame: 1 month
Contrast Sensitivity Photopic
Time frame: 1 month
Contrast Sensitivity Mesoptic 1.5 Cpd
Time frame: 1 month
Contrast Sensitivity Mesoptic
Time frame: 1 month
Posterior Capsule Opacification
Time frame: 12 months

Results and safety

Results posted to the registry on 5 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Akreos Intraocular Lens	75	69

Primary outcome: Low Contrast Best Corrected Visual Acuity Following Cataract Surgery

Time frame: 3 months. Mean (Standard Deviation). Unit: LogMAR

Measure	Akreos Advanced Optics n = 67	Akreos Adapt n = 67
Value	0.22 (0.096)	0.24 (0.131)

Population analysed: 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.

Primary outcome: Low Contrast Uncorrected Visual Acuity Following Cataract Surgery

Time frame: 3 months. Mean (Standard Deviation). Unit: LogMAR

Measure	Akreos Advanced Optics n = 68	Akreos Adapt n = 68
Value	0.33 (0.163)	0.35 (0.191)

Population analysed: 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

Primary outcome: Photopic Contrast Sensitivity

Time frame: 3 months. Mean (Standard Deviation). Unit: Log 10

Measure	Akreos Advanced Optics n = 68	Akreos Adapt n = 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)

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

Primary outcome: Mesoptic Contrast Sensitivity

Time frame: 3 Months. Mean (Standard Deviation). Unit: Log 10

Measure	Akreos Advanced Optics n = 68	Akreos Adapt n = 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)

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

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Ocular adverse events were measured over 24 month study period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Akreos Advanced Intraocular Lenses	0 of 69 (0%)	0 of 69 (0%)	Not reported
Akreos Adapt Intraocular Lens	0 of 69 (0%)	0 of 69 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Advanced Akreos Adapt in one operated eye. and Akreos Adapt in fellow operated eye. in people with Cataract, run by Bausch & Lomb Incorporated.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Low Contrast Best Corrected Visual Acuity Following Cataract Surgery (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00786565.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2011.