CataractNCT00762216

Rotational Stability of the AcrySof® Toric

A study testing AcrySof® Toric intraocular lens in people with Cataract, run by Alcon Research at 1 site in United States.

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

To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Cataract
What is being tested?: AcrySof® Toric intraocular lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteUnited States
Study dates: May 2008to Jun 2009
Phase: Interventional
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 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Monolateral or bilateral cataracts
anticipated intraocular lens (IOL) power of +10 Diopters (D) ~ +25D
0.75 ~ 2.0 D of astigmatism measured preoperatively by Keratometry readings
able to sign the informed consent, to comply with scheduled visits and other study procedures

Who cannot join

Preoperative ocular pathology
previous intraocular or corneal surgery
an increased risk for complications which could require vitreoretinal surgery
corneal irregularities
corneal opacities
current contact lens usage
uncontrolled diabetes

Trial locations and contacts

1 site in 1 country.

United States1 site

Alcon Call Center
Fort Worth, Texas, 76134

Other trials in United States

About this study

To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.

Conditions: Cataract
Being tested: AcrySof® Toric intraocular lens
Keywords: Cataract
Medical subject headings: Cataract

What participants receive

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

AcrySof® Toric intraocular lensDevice
Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery

Study groups in NCT00762216
Study group	Role	What they receive
Toric	Other	Implantation with the AcrySof® Toric intraocular lens Receives: Device: AcrySof® Toric intraocular lens

What is being measured

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

Rotational Stability
Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.
Measured: 6 Months post-surgery

Secondary outcomes (1)

Residual Refractive Cylinder
The refractive astigmatism 6 months post-surgery, measured in diopters.
Measured: 6 Months post-surgery

Timeline

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

May 2008Jun 2009

First posted30 Sep 2008 (estimated)
Study startMay 2008
Primary completionJun 2009

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00762216
Sponsor's protocol ID: RM-08-001
Status last verified: May 2010
First submitted: 26 Sep 2008
Last updated: 31 Oct 2012
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rotational Stability of the AcrySof® Toric
ClinicalTrials.gov ID: NCT00762216
Acronym / sponsor ID: RM-08-001
Conditions: Cataract
Keywords: Cataract
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Jun 2009 (actual)
First posted: 30 Sep 2008 (estimated)
Results: Posted 10 May 2010

Clinical summary

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

To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Toric	Other	Device: AcrySof® Toric intraocular lensImplantation with the AcrySof® Toric intraocular lens

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Monolateral or bilateral cataracts
anticipated intraocular lens (IOL) power of +10 Diopters (D) ~ +25D
0.75 ~ 2.0 D of astigmatism measured preoperatively by Keratometry readings
able to sign the informed consent, to comply with scheduled visits and other study procedures

Key exclusion criteria (7 listed)

Preoperative ocular pathology
previous intraocular or corneal surgery
an increased risk for complications which could require vitreoretinal surgery
corneal irregularities
corneal opacities

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
AcrySof® Toric intraocular lensImplantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery	Device	Toric

Primary outcome

Rotational Stability
Time frame: 6 Months post-surgery
Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.

1 secondary outcome

Residual Refractive Cylinder
Time frame: 6 Months post-surgery

Results and safety

Results posted to the registry on 10 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Toric	71	71

Primary outcome: Rotational Stability

Time frame: 6 Months post-surgery. Mean (Standard Error). Unit: degrees

Measure	Toric n = 67
Value	4 (3)

Population analysed: 67 eyes (64 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications. Two (2) additional eyes had no operative intraocular lens (IOL) axis noted on file and were omitted from the analysis of IOL rotation.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Toric	0 of 71 (0%)	0 of 71 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingObservational study
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RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AcrySof® Toric intraocular lens in people with Cataract, run by Alcon Research at 1 site in United States.

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 4 inclusion and 7 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 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2010). 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?

Rotational Stability (time frame: 6 Months post-surgery). 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 NCT00762216.

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 31 Oct 2012.