Astigmatism
Conditions
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).
Interventions
DEVICEenVista® 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
DEVICEenVista control lens
Spherical Control lens
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
A Prospective, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control IOL Control IOL - Spherical control lens | 79 |
| Toric IOL1.25 D Toric IOL1.25 D - Toric cylinder power of 1.25 diopters (D) | 80 |
| Toric IOL 2.00 D Toric IOL 2.00 D - - Toric cylinder power of 2.00 diopters (D) | 20 |
| Toric IOL 2.75 D Toric IOL 2.75 D - Toric cylinder power of 2.75 diopters (D) | 12 |
| Total | 191 |
Baseline characteristics
| Characteristic | Control IOL | Toric IOL1.25 D | Toric IOL 2.00 D | Toric IOL 2.75 D | Total |
|---|---|---|---|---|---|
| Age, Continuous | 69.5 years STANDARD_DEVIATION 8.6 | 71.1 years STANDARD_DEVIATION 8.8 | 68.7 years STANDARD_DEVIATION 9.1 | 69.6 years STANDARD_DEVIATION 8.8 | 70.1 years STANDARD_DEVIATION 8.7 |
| Sex: Female, Male Female | 36 Participants | 49 Participants | 8 Participants | 9 Participants | 102 Participants |
| Sex: Female, Male Male | 43 Participants | 31 Participants | 12 Participants | 3 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 80 | 0 / 20 | 0 / 12 |
| other Total, other adverse events | 38 / 79 | 39 / 80 | 7 / 20 | 2 / 12 |
| serious Total, serious adverse events | 0 / 79 | 2 / 80 | 1 / 20 | 0 / 12 |
Outcome results
Primary
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.
Time frame: Final Visit (scheduled within window: days 120-180)
Population: Evaluable participants at the specified timepoint are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control IOL | Mean Best-corrected Distance Visual Acuity (BCDVA) at Final Visit | 0.01 logMAR | Standard Deviation 0.09 |
| Toric IOL1.25 D | Mean Best-corrected Distance Visual Acuity (BCDVA) at Final Visit | 0.00 logMAR | Standard Deviation 0.09 |
| Toric IOL 2.00 D | Mean Best-corrected Distance Visual Acuity (BCDVA) at Final Visit | 0.05 logMAR | Standard Deviation 0.1 |
| Toric IOL 2.75 D | Mean Best-corrected Distance Visual Acuity (BCDVA) at Final Visit | -0.01 logMAR | Standard Deviation 0.09 |
Primary
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).
Time frame: Baseline, Final Visit (scheduled within window: days 120-180)
Population: Evaluable participants at the specified timepoint are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control IOL | Mean Dioptric Change in Cylinder | -0.479 diopter | Standard Deviation 0.665 |
| Toric IOL1.25 D | Mean Dioptric Change in Cylinder | -0.865 diopter | Standard Deviation 0.487 |
| Toric IOL 2.00 D | Mean Dioptric Change in Cylinder | -1.413 diopter | Standard Deviation 0.532 |
| Toric IOL 2.75 D | Mean Dioptric Change in Cylinder | -1.944 diopter | Standard Deviation 0.327 |
Primary
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).
Time frame: Form 3 Visit (window: days 30-60), Final Visit (window: days 120-180)
Population: The measure was not assessed for the control IOL. Evaluable participants at the specified timepoint are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Toric IOL1.25 D | Percentage of Participants With Intraocular Lens (IOL) Rotation of Less Than or Equal to Five Degrees | 74 Participants |
| Toric IOL 2.00 D | Percentage of Participants With Intraocular Lens (IOL) Rotation of Less Than or Equal to Five Degrees | 15 Participants |
| Toric IOL 2.75 D | Percentage of Participants With Intraocular Lens (IOL) Rotation of Less Than or Equal to Five Degrees | 12 Participants |
Primary
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)
Population: Evaluable participants at the specified timepoint are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control IOL | Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended. | Within 1.00 D of intended | 45 Participants |
| Control IOL | Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended. | Within 0.50 D of intended | 27 Participants |
| Toric IOL1.25 D | Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended. | Within 1.00 D of intended | 71 Participants |
| Toric IOL1.25 D | Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended. | Within 0.50 D of intended | 43 Participants |
| Toric IOL 2.00 D | Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended. | Within 0.50 D of intended | 12 Participants |
| Toric IOL 2.00 D | Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended. | Within 1.00 D of intended | 17 Participants |
| Toric IOL 2.75 D | Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended. | Within 0.50 D of intended | 8 Participants |
| Toric IOL 2.75 D | Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended. | Within 1.00 D of intended | 12 Participants |
Secondary
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.
Time frame: Final Visit (scheduled within window: days 120-180)
Population: Evaluable participants at the specified timepoint are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control IOL | Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit | 0.19 logMAR | Standard Deviation 0.16 |
| Toric IOL1.25 D | Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit | 0.11 logMAR | Standard Deviation 0.14 |
| Toric IOL 2.00 D | Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit | 0.12 logMAR | Standard Deviation 0.11 |
| Toric IOL 2.75 D | Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit | 0.13 logMAR | Standard Deviation 0.18 |