AstigmatismNCT01852084

Hydrophobic Acrylic Toric IOL Designed to Reduce the Effects of Preoperative Corneal Astigmatism

A study testing enVista® One-Piece Hydrophobic Acrylic Toric IOL in people with Astigmatism, run by Bausch & Lomb Incorporated 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

The investigational enVista IOL, Model MX60Tis equipped with toric optics and axis marks on the posterior surface to minimize the possibility of surgically induced astigmatism. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Astigmatism
What is being tested?: enVista® One-Piece Hydrophobic Acrylic Toric IOL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 191 participants
Where: 1 siteUnited States
Study dates: 6 Mar 2013to Dec 2016
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must have a clinically significant cataract in the study eye that is considered amenable to treatment with standard phacoemulsification cataract extraction.
Subjects must require a lens power from 16.0 D to 27.0 D in the study eye.
Subjects must be willing to discontinue contact lens wear for the duration of the study and, demonstrate stability prior to biometry and surgery in the study eye.
Subjects must have a best corrected distance visual acuity (BCDVA) projected to be better than 20/30 after toric IOL implantation in the study eye.
Subjects must have predicted postoperative corneal astigmatism between 0.90D and 2.40D in the study eye, as determined by the Toric Calculator.
Subjects must have a minimum preoperative corneal astigmatism of 0.90 D in the study eye.
Subjects must have a dilated preoperative pupil size greater than or equal to 5.0 mm in the study eye.

Who cannot join

Subjects who have had previous intraocular or corneal surgery in the study eye.
Subjects with any clinically significant ocular pathology which would be expected to reduce potential BCDVA to 20/30 or worse in the study eye during the course of the study.
Subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery.
Subjects with associated ocular conditions which could affect the stability of the IOL in the study eye.
Subjects with a traumatic cataract in the study eye.
Subjects with uncontrolled glaucoma in the study eye.

Show all 12Show fewer

Subjects with clinically significant irregular corneal astigmatism in the study eye, as determined by the medical judgment of the Investigator.
Subjects with clinically significant corneal pathology potentially affecting topography of either eye.
Subjects with any ocular condition that could prevent the possibility of a visual outcome better than 20/30 in the study eye.
Subjects with a difference of greater than 0.50D of corneal astigmatism as measured with the IOL Master and the topographer in the study eye using vector analysis.
Subjects with an anterior chamber depth <2mm in the study eye.
Subjects with potential BCDVA of 20/200 or worse in the fellow eye.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bausch & Lomb
Irvine, California, 92618

Other trials in United States

About this study

Official title: To Evaluate the Safety and Effectiveness of the EnVista® One-Piece Hydrophobic Acrylic Toric IOL Designed to Reduce the Effects of Preoperative Corneal Astigmatism on Postoperative Refraction Following Cataract Surgery

The investigational enVista IOL, Model MX60Tis equipped with toric optics and axis marks on the posterior surface to minimize the possibility of surgically induced astigmatism.

Read the detailed description

The investigational enVista Toric IOL, Model MX60T, and the currently approved Model MX60, are identical with the exception of the addition of toric optics and axis marks on the posterior optic surface for the correction of astigmatism on the Model MX60T. Both lenses have an aspheric biconvex optic with a modified C haptic monoblock, single-piece design. The design and material of both the MX60 and MX60T allow them to be folded and inserted through small incisions to minimize the possibility of surgically induced astigmatism (SIA).

Conditions: Astigmatism
Being tested: enVista® One-Piece Hydrophobic Acrylic Toric IOL, enVista control lens
Medical subject headings: Astigmatism

What participants receive

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

enVista® One-Piece Hydrophobic Acrylic Toric IOLDevice
Test lens having a toric cylinder power of either 1.25 diopters (D), 2.00 D, or 2.75 D
enVista control lensDevice
Spherical Control lens

Study groups in NCT01852084
Study group	Role	What they receive
enVista® One-Piece Hydrophobic Acrylic Toric IOL	Experimental	Toric cylinder power of either 1.25 diopters (D), 2.00 D, or 2.75 D Receives: Device: enVista® One-Piece Hydrophobic Acrylic Toric IOL
enVista control lens	Experimental	Spherical control lens Receives: Device: enVista control lens

What is being measured

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

Mean Dioptric Change in Cylinder
Dioptric change in cylinder from the preoperative keratometric cylinder magnitude to postoperative manifest refraction cylinder magnitude (referenced to the corneal plane).
Measured: Baseline, Final Visit (scheduled within window: days 120-180)
Percentage of Participants With Intraocular Lens (IOL) Rotation of Less Than or Equal to Five Degrees
Intraocular Lens (IOL) rotation of less than or equal to five degrees between Forms 3 (scheduled within window: days 30-60) and final visit (scheduled within window: days 120-180).
Measured: Form 3 Visit (window: days 30-60), Final Visit (window: days 120-180)
Mean Best-corrected Distance Visual Acuity (BCDVA) at Final Visit
Best-corrected distance visual acuity (BCDVA) at Final Visit, expressed as logarithm of the minimum angle of resolution (logMAR). Corrected means spectacle corrected. Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters were recorded. A decrease in the number of correct letters indicates a decrease in visual acuity.
Measured: Final Visit (scheduled within window: days 120-180)
Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended.
Measured: Final Visit (scheduled within window: days 120-180)

Secondary outcomes (1)

Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit
Uncorrected distance visual acuity (UCDVA), expressed as logarithm of the minimum angle of resolution (logMAR). Uncorrected means not spectacle-corrected. Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters were recorded. A decrease in the number of correct letters indicates a decrease in visual acuity.
Measured: Final Visit (scheduled within window: days 120-180)

Timeline

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

6 Mar 2013Dec 2016

First posted13 May 2013 (estimated)
Study start6 Mar 2013
Primary completion18 Jul 2016
Study completionDec 2016

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 AstigmatismStudies 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: Parallel groups
Model description: A Prospective, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 191 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01852084
Sponsor's protocol ID: 761
Status last verified: Aug 2020
First submitted: 9 May 2013
Last updated: 16 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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?

See locations

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
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The EYERISING Study
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Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
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Recruiting
Clareon TruPlus Study
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All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: To Evaluate the Safety and Effectiveness of the EnVista® One-Piece Hydrophobic Acrylic Toric IOL Designed to Reduce the Effects of Preoperative Corneal Astigmatism on Postoperative Refraction Following Cataract Surgery
ClinicalTrials.gov ID: NCT01852084
Acronym / sponsor ID: 761
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 191 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: 6 Mar 2013 (actual)
Primary completion: 18 Jul 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 13 May 2013 (estimated)
Results: Posted 16 Sep 2020

Clinical summary

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

The investigational enVista IOL, Model MX60Tis equipped with toric optics and axis marks on the posterior surface to minimize the possibility of surgically induced astigmatism.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: A Prospective, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness

Arm	Type	Receives
enVista® One-Piece Hydrophobic Acrylic Toric IOL	Experimental	Device: enVista® One-Piece Hydrophobic Acrylic Toric IOLToric cylinder power of either 1.25 diopters (D), 2.00 D, or 2.75 D
enVista control lens	Experimental	Device: enVista control lensSpherical control lens

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subjects must have a clinically significant cataract in the study eye that is considered amenable to treatment with standard phacoemulsification cataract extraction.
Subjects must require a lens power from 16.0 D to 27.0 D in the study eye.
Subjects must be willing to discontinue contact lens wear for the duration of the study and, demonstrate stability prior to biometry and surgery in the study eye.
Subjects must have a best corrected distance visual acuity (BCDVA) projected to be better than 20/30 after toric IOL implantation in the study eye.
Subjects must have predicted postoperative corneal astigmatism between 0.90D and 2.40D in the study eye, as determined by the Toric Calculator.

Key exclusion criteria (12 listed)

Subjects who have had previous intraocular or corneal surgery in the study eye.
Subjects with any clinically significant ocular pathology which would be expected to reduce potential BCDVA to 20/30 or worse in the study eye during the course of the study.
Subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery.
Subjects with associated ocular conditions which could affect the stability of the IOL in the study eye.
Subjects with a traumatic cataract in the study eye.

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
enVista® One-Piece Hydrophobic Acrylic Toric IOLTest lens having a toric cylinder power of either 1.25 diopters (D), 2.00 D, or 2.75 D	Device	enVista® One-Piece Hydrophobic Acrylic Toric IOL
enVista control lensSpherical Control lens	Device	enVista control lens

Primary outcome

Mean Dioptric Change in Cylinder
Time frame: Baseline, Final Visit (scheduled within window: days 120-180)
Dioptric change in cylinder from the preoperative keratometric cylinder magnitude to postoperative manifest refraction cylinder magnitude (referenced to the corneal plane).
Percentage of Participants With Intraocular Lens (IOL) Rotation of Less Than or Equal to Five Degrees
Time frame: Form 3 Visit (window: days 30-60), Final Visit (window: days 120-180)
Intraocular Lens (IOL) rotation of less than or equal to five degrees between Forms 3 (scheduled within window: days 30-60) and final visit (scheduled within window: days 120-180).
Mean Best-corrected Distance Visual Acuity (BCDVA) at Final Visit
Time frame: Final Visit (scheduled within window: days 120-180)
Best-corrected distance visual acuity (BCDVA) at Final Visit, expressed as logarithm of the minimum angle of resolution (logMAR). Corrected means spectacle corrected. Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters were recorded. A decrease in the number of correct letters indicates a decrease in visual acuity.
Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended.
Time frame: Final Visit (scheduled within window: days 120-180)

1 secondary outcome

Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit
Time frame: Final Visit (scheduled within window: days 120-180)

Results and safety

Results posted to the registry on 16 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control IOL	79	79
Toric IOL1.25 D	80	80
Toric IOL 2.00 D	20	18
Toric IOL 2.75 D	12	12

Primary outcome: Mean Dioptric Change in Cylinder

Time frame: Baseline, Final Visit (scheduled within window: days 120-180). Mean (Standard Deviation). Unit: diopter

Measure	Control IOL n = 78	Toric IOL1.25 D n = 80	Toric IOL 2.00 D n = 18	Toric IOL 2.75 D n = 12
Value	-0.479 (0.665)	-0.865 (0.487)	-1.413 (0.532)	-1.944 (0.327)

Population analysed: Evaluable participants at the specified timepoint are included in the analysis.

Primary outcome: Percentage of Participants With Intraocular Lens (IOL) Rotation of Less Than or Equal to Five Degrees

Time frame: Form 3 Visit (window: days 30-60), Final Visit (window: days 120-180). Count of participants. Unit: Participants

Measure	Control IOL n = 0	Toric IOL1.25 D n = 74	Toric IOL 2.00 D n = 15	Toric IOL 2.75 D n = 12
Value	–	74	15	12

Population analysed: The measure was not assessed for the control IOL. Evaluable participants at the specified timepoint are included in the analysis.

Primary outcome: Mean Best-corrected Distance Visual Acuity (BCDVA) at Final Visit

Time frame: Final Visit (scheduled within window: days 120-180). Mean (Standard Deviation). Unit: logMAR

Measure	Control IOL n = 78	Toric IOL1.25 D n = 80	Toric IOL 2.00 D n = 18	Toric IOL 2.75 D n = 12
Value	0.01 (0.09)	0.00 (0.09)	0.05 (0.10)	-0.01 (0.09)

Population analysed: Evaluable participants at the specified timepoint are included in the analysis.

Primary outcome: Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended.

Time frame: Final Visit (scheduled within window: days 120-180). Count of participants. Unit: Participants

Measure	Control IOL n = 78	Toric IOL1.25 D n = 80	Toric IOL 2.00 D n = 18	Toric IOL 2.75 D n = 12
Within 0.50 D of intended	27	43	12	8
Within 1.00 D of intended	45	71	17	12

Population analysed: Evaluable participants at the specified timepoint are included in the analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 180 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control IOL	0 of 79 (0%)	38 of 79 (48.1%)	0 of 79
Toric IOL1.25 D	2 of 80 (2.5%)	39 of 80 (48.8%)	0 of 80
Toric IOL 2.00 D	1 of 20 (5%)	7 of 20 (35%)	0 of 20
Toric IOL 2.75 D	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Astigmatism

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
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Recruiting
Clareon TruPlus Study
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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.

Mark Packer, MD study director

Bausch & Lomb Incorporated

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

Questions about this trial

What is this clinical trial studying?

A study testing enVista® One-Piece Hydrophobic Acrylic Toric IOL in people with Astigmatism, run by Bausch & Lomb Incorporated 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 7 inclusion and 12 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 16 Sep 2020. 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 16 Sep 2020). 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 Dioptric Change in Cylinder (time frame: Baseline, Final Visit (scheduled within window: days 120-180)). The study lists 4 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 NCT01852084.

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 16 Sep 2020.