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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01852084
• Collaborator: (none)
• Enrollment: 191
• Location: 1
• Arms: 2
• Actual Duration (Months): 44.9
• Patients Per Site Per Month: 4.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: enVista® One-Piece Hydrophobic Acrylic Toric IOL; Device: enVista control lens	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 191 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A Prospective, Multicenter Clinical Trial to Evaluate the Safety and EffectivenessA Prospective, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 6, 2013
• Actual Primary Completion Date: Jul 18, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean Dioptric Change in Cylinder [Baseline, Final Visit (scheduled within window: days 120-180)]

   Dioptric change in cylinder from the preoperative keratometric cylinder magnitude to postoperative manifest refraction cylinder magnitude (referenced to the corneal plane).

2. Percentage of Participants With Intraocular Lens (IOL) Rotation of Less Than or Equal to Five Degrees [Form 3 Visit (window: days 30-60), Final Visit (window: days 120-180)]

   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).

3. Mean Best-corrected Distance Visual Acuity (BCDVA) at Final Visit [Final Visit (scheduled within window: days 120-180)]

   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.

4. 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

1. Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit [Final Visit (scheduled within window: days 120-180)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb	Irvine	California	United States	92618

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01852084
• Other Study ID Numbers: 761
• First Posted: May 13, 2013
• Last Update Posted: Sep 16, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Arm/Group Title	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D
Arm/Group Description	Control IOL - Spherical control lens	Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)	Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)	Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
Period Title: Overall Study
STARTED	79	80	20	12
COMPLETED	79	80	18	12
NOT COMPLETED	0	0	2	0

Baseline Characteristics

Arm/Group Title	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D	Total
Arm/Group Description	Control IOL - Spherical control lens	Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)	Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)	Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)	Total of all reporting groups
Overall Participants	79	80	20	12	191
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.5 (8.6)	71.1 (8.8)	68.7 (9.1)	69.6 (8.8)	70.1 (8.7)
Sex: Female, Male (Count of Participants)
Female	36 45.6%	49 61.3%	8 40%	9 75%	102 53.4%
Male	43 54.4%	31 38.8%	12 60%	3 25%	89 46.6%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Evaluable participants at the specified timepoint are included in the analysis.

Arm/Group Title	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D
Arm/Group Description	Control IOL - Spherical control lens	Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)	Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)	Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
Measure Participants	78	80	18	12
Mean (Standard Deviation) [diopter]	-0.479 (0.665)	-0.865 (0.487)	-1.413 (0.532)	-1.944 (0.327)

2. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

The measure was not assessed for the control IOL. Evaluable participants at the specified timepoint are included in the analysis.

Arm/Group Title	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D
Arm/Group Description	Control IOL - Spherical control lens	Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)	Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)	Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
Measure Participants	0	74	15	12
Count of Participants [Participants]	74 93.7%	15 18.8%	12 60%

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Evaluable participants at the specified timepoint are included in the analysis.

Arm/Group Title	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D
Arm/Group Description	Control IOL - Spherical control lens	Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)	Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)	Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
Measure Participants	78	80	18	12
Mean (Standard Deviation) [logMAR]	0.01 (0.09)	0.00 (0.09)	0.05 (0.10)	-0.01 (0.09)

4. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Evaluable participants at the specified timepoint are included in the analysis.

Arm/Group Title	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D
Arm/Group Description	Control IOL - Spherical control lens	Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)	Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)	Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
Measure Participants	78	80	18	12
Within 0.50 D of intended	27 34.2%	43 53.8%	12 60%	8 66.7%
Within 1.00 D of intended	45 57%	71 88.8%	17 85%	12 100%

5. Secondary Outcome

Title	Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit
Description	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)

Outcome Measure Data

Analysis Population Description

Evaluable participants at the specified timepoint are included in the analysis.

Arm/Group Title	Control IOL	Toric IOL1.25 D	Toric IOL 2.00 D	Toric IOL 2.75 D
Arm/Group Description	Control IOL - Spherical control lens	Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)	Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)	Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
Measure Participants	78	80	18	12
Mean (Standard Deviation) [logMAR]	0.19 (0.16)	0.11 (0.14)	0.12 (0.11)	0.13 (0.18)

Adverse Events

Time Frame	180 days
Arm/Group Title	Control IOL		Toric IOL1.25 D		Toric IOL 2.00 D		Toric IOL 2.75 D
Arm/Group Description	Control IOL - Spherical control lens		Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D)		Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D)		Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D)
All Cause Mortality
	Control IOL		Toric IOL1.25 D		Toric IOL 2.00 D		Toric IOL 2.75 D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/79 (0%)		0/80 (0%)		0/20 (0%)		0/12 (0%)
Serious Adverse Events
	Control IOL		Toric IOL1.25 D		Toric IOL 2.00 D		Toric IOL 2.75 D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/79 (0%)		2/80 (2.5%)		1/20 (5%)		0/12 (0%)
Eye disorders
Epiretinal membrane	0/79 (0%)		0/80 (0%)		1/20 (5%)		0/12 (0%)
IOL tilt	0/79 (0%)		1/80 (1.3%)		0/20 (0%)		0/12 (0%)
Anterior lens vault	0/79 (0%)		1/80 (1.3%)		0/20 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Control IOL		Toric IOL1.25 D		Toric IOL 2.00 D		Toric IOL 2.75 D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/79 (48.1%)		39/80 (48.8%)		7/20 (35%)		2/12 (16.7%)
Eye disorders
Corneal edema	15/79 (19%)		18/80 (22.5%)		3/20 (15%)		0/12 (0%)
Anterior chamber cell	17/79 (21.5%)		15/80 (18.8%)		1/20 (5%)		1/12 (8.3%)
Anterior chamber flare	4/79 (5.1%)		3/80 (3.8%)		1/20 (5%)		1/12 (8.3%)
Punctate keratosis	6/79 (7.6%)		5/80 (6.3%)		0/20 (0%)		0/12 (0%)
Visual acuity reduced	7/79 (8.9%)		2/80 (2.5%)		1/20 (5%)		1/12 (8.3%)
Dry eye	1/79 (1.3%)		1/80 (1.3%)		2/20 (10%)		0/12 (0%)
Diplopia	0/79 (0%)		1/80 (1.3%)		1/20 (5%)		0/12 (0%)
Trichiasis	0/79 (0%)		1/80 (1.3%)		1/20 (5%)		0/12 (0%)
Maculopathy	0/79 (0%)		0/80 (0%)		1/20 (5%)		0/12 (0%)
Photophobia	0/79 (0%)		0/80 (0%)		1/20 (5%)		0/12 (0%)
Investigations
Intraocular pressure increased	3/79 (3.8%)		5/80 (6.3%)		1/20 (5%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Contact sponsor directly for details.