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

NCT01852084 | Completed Results

• 1 other identifier: 761
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit

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

Study Arms (2)

enVista® One-Piece Hydrophobic Acrylic Toric IOL

EXPERIMENTAL

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 lens

EXPERIMENTAL

Spherical control lens

Device: enVista control lens

Interventions

enVista® One-Piece Hydrophobic Acrylic Toric IOL DEVICE

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

enVista® One-Piece Hydrophobic Acrylic Toric IOL

enVista control lens DEVICE

Spherical Control lens

enVista control lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

susan.harris@bauschhealth.com

Study Officials

• Mark Packer, MD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 13, 2013
• Study Start: March 6, 2013
• Primary Completion: July 18, 2016
• Study Completion: December 1, 2016
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)