CompletedNCT01852084Updated Sep 16, 2020Results posted

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

An interventional study of enVista® One-Piece Hydrophobic Acrylic Toric IOL and enVista control lens in Astigmatism, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Bausch & Lomb Incorporated · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 191
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Astigmatism

Browse trials for

Astigmatism 413

In context

Astigmatism

413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.

This study's enrollment of 191 is above the median of 55 across 321 interventional studies indexed under Astigmatism.

Browse Astigmatism studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 191 participants (actual)

Study arms

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

Interventions

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

What researchers measure

Primary outcomes

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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Final Visit (scheduled within window: days 120-180)

Secondary outcomes

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.
Time frame: Final Visit (scheduled within window: days 120-180)

Results

Posted Sep 16, 2020

Participant flow

Participant flow — Overall Study
Milestone	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D
Started	79	80	20	12
Completed	79	80	18	12
Not completed	0	0	2	0

Outcome measures

PrimaryMean 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).

Time frame:: Baseline, Final Visit (scheduled within window: days 120-180)
Reported as:: Mean · diopter

Mean Dioptric Change in Cylinder
diopter	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D
Mean Dioptric Change in Cylinder	-0.479 ± 0.665	-0.865 ± 0.487	-1.413 ± 0.532	-1.944 ± 0.327

PrimaryPercentage 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).

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

Percentage of Participants With Intraocular Lens (IOL) Rotation of Less Than or Equal to Five Degrees
Participants	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D
Percentage of Participants With Intraocular Lens (IOL) Rotation of Less Than or Equal to Five Degrees	—	74	15	12

PrimaryMean 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.

Time frame:: Final Visit (scheduled within window: days 120-180)
Reported as:: Mean · logMAR

Mean Best-corrected Distance Visual Acuity (BCDVA) at Final Visit
logMAR	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D
Mean Best-corrected Distance Visual Acuity (BCDVA) at Final Visit	0.01 ± 0.09	0.00 ± 0.09	0.05 ± 0.10	-0.01 ± 0.09

PrimaryPercentage 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)
Reported as:: Count of participants · Participants

Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended.
Participants	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D
Within 0.50 D of intended	27	43	12	8
Within 1.00 D of intended	45	71	17	12

SecondaryMean 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.

Time frame:: Final Visit (scheduled within window: days 120-180)
Reported as:: Mean · logMAR

Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit
logMAR	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D
Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit	0.19 ± 0.16	0.11 ± 0.14	0.12 ± 0.11	0.13 ± 0.18

Adverse events

Collected over 180 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Control IOL	0/79 (0%)	0/79 (0%)	38/79 (48.1%)
Toric IOL1.25 D	0/80 (0%)	2/80 (2.5%)	39/80 (48.8%)
Toric IOL 2.00 D	0/20 (0%)	1/20 (5%)	7/20 (35%)
Toric IOL 2.75 D	0/12 (0%)	0/12 (0%)	2/12 (16.7%)

Most frequent serious events

Most frequent serious events
Event	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D
Epiretinal membraneEye disorders	0/79	0/80	1/20	0/12
IOL tiltEye disorders	0/79	1/80	0/20	0/12
Anterior lens vaultEye disorders	0/79	1/80	0/20	0/12

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D
Corneal edemaEye disorders	15/79	18/80	3/20	0/12
Anterior chamber cellEye disorders	17/79	15/80	1/20	1/12
Dry eyeEye disorders	1/79	1/80	2/20	0/12
Visual acuity reducedEye disorders	7/79	2/80	1/20	1/12
Anterior chamber flareEye disorders	4/79	3/80	1/20	1/12
Punctate keratosisEye disorders	6/79	5/80	0/20	0/12
Intraocular pressure increasedInvestigations	3/79	5/80	1/20	0/12
DiplopiaEye disorders	0/79	1/80	1/20	0/12
TrichiasisEye disorders	0/79	1/80	1/20	0/12
MaculopathyEye disorders	0/79	0/80	1/20	0/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D	Total
Mean	69.5 ± 8.6	71.1 ± 8.8	68.7 ± 9.1	69.6 ± 8.8	70.1 ± 8.7

Sex: Female, Male
Sex: Female, Male(Participants)	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D	Total
Female	36	49	8	9	102
Male	43	31	12	3	89

Study locations

1 site

Bausch & Lomb
Irvine, California 92618, United States

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01852084
Lead sponsor: Bausch & Lomb Incorporated
Responsible party: Sponsor
First posted: May 13, 2013
Start date: Mar 6, 2013
Primary completion: Jul 18, 2016
Completion: Dec 2016
Results posted: Sep 16, 2020
Last update: Sep 16, 2020

Study contacts

Mark Packer, MD

study director · Bausch & Lomb Incorporated

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Astigmatism→

Other studies from this sponsor

Bausch & Lomb Incorporated

Start the discussion