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

Primary Purpose

Astigmatism

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

enVista® One-Piece Hydrophobic Acrylic Toric IOL

enVista control lens

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Bausch & Lomb

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

enVista® One-Piece Hydrophobic Acrylic Toric IOL

enVista control lens

Arm Description

Toric cylinder power of either 1.25 diopters (D), 2.00 D, or 2.75 D

Spherical control lens

Outcomes

Primary Outcome Measures

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).

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).

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.

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01852084

First Posted

May 9, 2013

Last Updated

August 28, 2020

Sponsor

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01852084

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

March 6, 2013 (Actual)

Primary Completion Date

July 18, 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Astigmatism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A Prospective, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

191 (Actual)

8. Arms, Groups, and Interventions

Arm Title

enVista® One-Piece Hydrophobic Acrylic Toric IOL

Arm Type

Experimental

Arm Description

Toric cylinder power of either 1.25 diopters (D), 2.00 D, or 2.75 D

Arm Title

enVista control lens

Arm Type

Experimental

Arm Description

Spherical control lens

Intervention Type

Device

Intervention Name(s)

enVista® One-Piece Hydrophobic Acrylic Toric IOL

Intervention Description

Test lens having a toric cylinder power of either 1.25 diopters (D), 2.00 D, or 2.75 D

Intervention Type

Device

Intervention Name(s)

enVista control lens

Intervention Description

Spherical Control lens

Primary Outcome Measure Information:

Title

Mean Dioptric Change in Cylinder

Description

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)

Title

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

Description

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)

Title

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

Description

Time Frame

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

Title

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 Outcome Measure Information:

Title

Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Packer, MD

Organizational Affiliation

Bausch & Lomb Incorporated

Official's Role

Study Director

Facility Information:

Facility Name

Bausch & Lomb

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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