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

NCT ID: NCT01852084

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-06
• Study Completion Date: 2016-12-31

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).

Conditions

Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

enVista® One-Piece Hydrophobic Acrylic Toric IOL

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

Group Type: EXPERIMENTAL

enVista® One-Piece Hydrophobic Acrylic Toric IOL

Intervention Type: DEVICE

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

enVista control lens

Spherical control lens

Group Type: EXPERIMENTAL

enVista control lens

Intervention Type: DEVICE

Spherical Control lens

Interventions

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

Intervention Type: DEVICE

enVista control lens

Spherical Control lens

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Packer, MD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb

Irvine, California, United States

Countries

United States

Other Identifiers

761

Identifier Type: -

Identifier Source: org_study_id