N/A
Completed N=191
Hydrophobic Acrylic Toric IOL Designed to Reduce the Effects of Preoperative Corneal Astigmatism
Astigmatism
Source: ClinicalTrials.gov NCT01852084 ↗
Enrolled (actual)
191
Serious AEs
1.6%
Results posted
Sep 2020
Primary outcomePrimary: Mean Dioptric Change in Cylinder — -0.479; -0.865; -1.413; -1.944 diopter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Dioptric Change in Cylinder |
-0.479; -0.865; -1.413; -1.944 | — |
| PRIMARY Percentage of Participants With Intraocular Lens (IOL) Rotation of Less Than or Equal to Five Degrees |
74; 15; 12 | — |
| PRIMARY Mean Best-corrected Distance Visual Acuity (BCDVA) at Final Visit |
0.01; 0.00; 0.05; -0.01 | — |
| PRIMARY Percentage of Participants With Reduction in Cylinder Within 0.50 Diopter (D) and Within 1.00 D of Intended. |
27; 43; 12; 8; 45; 71 | — |
| SECONDARY Mean Uncorrected Distance Visual Acuity (UCDVA) at Final Visit |
0.19; 0.11; 0.12; 0.13 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01852084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.