CataractNCT02176343

Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses

A study testing AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL in people with Cataract and Presbyopia, run by Alcon Research.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to characterize the safety and effectiveness of the ACRYSOF IQ ReSTOR +2.5 diopter (D) Multifocal Toric Intraocular Lens (IOL) in subjects at least 3 months and no more than 14 months after IOL implantation. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Cataract, Presbyopia, Corneal Astigmatism
What is being tested?: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: No sites listed yet
Study dates: 21 Jul 2014to 22 Aug 2014
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must sign an informed consent form and be willing to come in for a visit at least 3 months and not more than 14 months after IOL implantation with the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL (Models SV25T2, SV25T3, SV25T4 and SV25T5);
Must be implanted with the correct lens based on preoperative corneal astigmatism as specified in the protocol;
Must complete a visit within 10 days after IOL implantation;
Successful capsular bag implantation with no surgical complications;
Other protocol-specified inclusion criteria may apply.

Who cannot join

IOL implanted prior to the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL;
Ocular or intraocular infection or inflammation at the time of the preoperative visit;
Any ocular surgery or intraocular laser procedure at or prior to the surgical visit;
Any conditions affecting the cornea (eg. corneal dystrophy, severe dry eye) at the preoperative visit;
Retinal conditions (e.g. degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit;
Known history of Type 1 or 2 diabetes for more than 5 years;

Show all 11Show fewer

Any ocular or systemic co-morbidity at the preoperative visit;
Pregnant at the preoperative visit or at the time of Postoperative Visit 2;
Preoperative corneal astigmatism ≤ 0.50 D;
Participation in another clinical study at the preoperative visit or at the time of the final study visit;
Other protocol-specified exclusion criteria may apply.

About this study

Read the detailed description

This is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data, and a prospective postoperative visit conducted at least 3 months but not more than 14 months after IOL implantation.

Conditions: Cataract, Presbyopia, Corneal Astigmatism
Being tested: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Keywords: Cataract, Intraocular lens, ACRYSOF IQ ReSTOR + 2.5 D Multifocal Toric IOL
Medical subject headings: Cataract, Presbyopia, Astigmatism

What participants receive

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

AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOLDevice
Also called Model SV25T2, Model SV25T3, Model SV25T4, Model SV25T5
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Study groups in NCT02176343
Study group	Role	What they receive
ReSTOR Toric +2.5	Experimental	AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL previously implanted during cataract surgery Receives: Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL

What is being measured

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

Mean Percent Reduction in Cylinder
Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis.
Measured: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D
Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
Measured: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D
Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
Measured: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean Uncorrected Distance Visual Acuity
Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Measured: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean Uncorrected Near Visual Acuity
VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Measured: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean Uncorrected Intermediate Visual Acuity
VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Measured: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean Best Corrected Distance Visual Acuity (BCDVA)
VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Measured: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean IOL Rotation
Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.
Measured: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)

Timeline

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

21 Jul 201422 Aug 2014

First posted27 Jun 2014 (estimated)
Study start21 Jul 2014
Primary completion22 Aug 2014
Study completion22 Aug 2014

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.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02176343
Sponsor's protocol ID: C-14-005
Status last verified: May 2017
First submitted: 25 Jun 2014
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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

Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Not yet recruiting
Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
Cataract, AMD - Age-Related Macular Degeneration
RecruitingObservational study
Capella Scientia Development Study
Cataract

All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses
ClinicalTrials.gov ID: NCT02176343
Acronym / sponsor ID: C-14-005
Conditions: Cataract, Presbyopia, Corneal Astigmatism
Keywords: Cataract, Intraocular lens, ACRYSOF IQ ReSTOR + 2.5 D Multifocal Toric IOL
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 21 Jul 2014 (actual)
Primary completion: 22 Aug 2014 (actual)
Study completion: 22 Aug 2014 (actual)
First posted: 27 Jun 2014 (estimated)
Results: Posted 29 Jun 2017

Clinical summary

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

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ReSTOR Toric +2.5	Experimental	Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOLAcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL previously implanted during cataract surgery

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Must sign an informed consent form and be willing to come in for a visit at least 3 months and not more than 14 months after IOL implantation with the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL (Models SV25T2, SV25T3, SV25T4 and SV25T5);
Must be implanted with the correct lens based on preoperative corneal astigmatism as specified in the protocol;
Must complete a visit within 10 days after IOL implantation;
Successful capsular bag implantation with no surgical complications;
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (11 listed)

IOL implanted prior to the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL;
Ocular or intraocular infection or inflammation at the time of the preoperative visit;
Any ocular surgery or intraocular laser procedure at or prior to the surgical visit;
Any conditions affecting the cornea (eg. corneal dystrophy, severe dry eye) at the preoperative visit;
Retinal conditions (e.g. degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit;

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® IQ ReSTOR® +2.5 D Multifocal Toric IOLAlso: Model SV25T2, Model SV25T3, Model SV25T4, Model SV25T5Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient	Device	ReSTOR Toric +2.5

Primary outcome

Mean Percent Reduction in Cylinder
Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis.
Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D
Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D
Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
Mean Uncorrected Distance Visual Acuity
Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Mean Uncorrected Near Visual Acuity
Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Mean Uncorrected Intermediate Visual Acuity
Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Mean Best Corrected Distance Visual Acuity (BCDVA)
Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Mean IOL Rotation
Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.

Results and safety

Results posted to the registry on 29 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ReSTOR Toric +2.5	31	31

Primary outcome: Mean Percent Reduction in Cylinder

Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation). Mean (Standard Deviation). Unit: percent change

Measure	ReSTOR Toric +2.5 n = 31
Value	60.94 (38.17)

Population analysed: As Treated

Primary outcome: Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D

Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation). Number. Unit: percentage of subjects

Measure	ReSTOR Toric +2.5 n = 31
Value	67.7

Population analysed: As Treated

Primary outcome: Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D

Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation). Number. Unit: percentage of subjects

Measure	ReSTOR Toric +2.5 n = 12
Value	100.0

Population analysed: This analysis population includes all subjects who provided informed consent and were determined eligible based upon the inclusion and exclusion criteria, having preoperative astigmatism \> 1.00 D.

Primary outcome: Mean Uncorrected Distance Visual Acuity

Time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation). Mean (Standard Deviation). Unit: logMAR

Measure	ReSTOR Toric +2.5 n = 31
Value	0.07 (0.12)

Population analysed: As Treated

Adverse events

Time frame: The time period of collection of AEs was preoperative to postoperative visit 3-14 months after IOL implantation. This analysis population includes all subjects who provided informed consent and were determined eligible based upon inclusion and exclusion criteria (As Treated).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ReSTOR Toric +2.5	3 of 31 (9.7%)	4 of 31 (12.9%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataract

Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Not yet recruiting
Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
Cataract, AMD - Age-Related Macular Degeneration
RecruitingObservational study
Capella Scientia Development Study
Cataract

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.

Clinical Manager, GCRA, Surgical study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL in people with Cataract and Presbyopia, run by Alcon Research.

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 5 inclusion and 11 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 2 Jul 2018. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2017). 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?

Mean Percent Reduction in Cylinder (time frame: Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)). The study lists 8 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 NCT02176343.

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 2 Jul 2018.