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

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: enVista® One-Piece Hydrophobic Acrylic Toric IOL; Device: enVista control lens

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).

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Bausch & Lomb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Test lens having a toric cylinder power of either 1.25 diopters (D), 2.00 D, or 2.75 D
Experimental: enVista control lens; Spherical control lens	Device: enVista control lens; Spherical Control lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.	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.		Final Visit (scheduled within window: days 120-180)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Final Visit (scheduled within window: days 120-180)

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Mark Packer, MD, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2013
• Primary Completion (Actual): July 18, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 9, 2013
• First Submitted That Met QC Criteria: May 9, 2013
• First Posted (Estimate): May 13, 2013

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: August 28, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: 761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes