Astigmatism, Cataract, Eye Diseases, Lens Opacities, Postcataract Aphakia
Conditions
Keywords
Intraocular Lens, Monofocal, Toric, Hydrophobic
Brief summary
This study is a prospective, multicenter, randomized, double masked trial comparing an investigational Monofocal Toric intraocular lens (IOL) (PODEYE TORIC CYL 1.5 D) and a commercially available non-toric monofocal IOL.
Detailed description
The study will include adult subjects with operable cataract in at least one eye along with pre-existing corneal astigmatism who are eligible for phacoemulsification cataract surgery followed by IOL implantation.
Interventions
DEVICEPODEYE TORIC Monofocal IOL
Cataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag.
DEVICEAlcon AcrySof SA60AT Monofocal IOL
Cataractous lens will be removed in the study eyes and the Alcon AcrySof SA60AT Monofocal IOL will be implanted in the capsular bag.
Sponsors
Beaver-Visitec International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
In order to minimize bias, site personnel performing postoperative study assessments of visual performance will be masked to subject treatment assignment until after the final database lock ("masked assessors").
Intervention model description
Up to 300 subjects shall be screened and approximately 230 subjects will be randomized and implanted at up to 10 clinical sites in USA. Subjects who meet all protocol-specified eligibility criteria will be randomized at a 1:1 ratio to receive either the PODEYE TORIC CYL 1.5 D IOL (test) or the control IOL in the study eye.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female adults, age 22 years or older at the Preoperative Visit. 2. Clinically significant cataract in the study eye eligible for standard phacoemulsification cataract surgery. 3. Eligible for receipt of an IOL power within the range of the investigational IOL in the study eye. (The Investigational IOL is available in powers from +15 D to +30 D Spherical Equivalent) 4. Pre-operative corneal astigmatism in the range: ≥0.75 D and ≤1.50 D in the study eye 5. Anticipated residual astigmatism of ≤0.3 D in the study eye as determined by the Toric Calculator. 6. Clear intraocular media other than cataract in the study eye. 7. Best corrected visual acuity equal to or worse than 0.3 logMAR, with or without a glare source in the study eye. * Ability to dilate pupil sufficiently (greater than or equal to 6.0 mm) to allow visualization of Toric IOL axis markings post-implantation in the study eye. * Projected BCDVA of 0.2 logMAR (20/32 Snellen) or better in the study eye after cataract surgery/IOL implantation, as determined by the medical judgment of the Investigator. * Contact lens users must be willing to discontinue wear of their lenses in the study eye in accordance with the following requirements: * Rigid gas permeable and toric lenses for ≥ 7 days prior to the Preoperative Visit * Soft non-toric contact lenses for ≥ 3 days prior to the Preoperative Visit * All contact lens wearers must demonstrate a stable refraction within ± 0.50 D MRSE and 15 degrees astigmatic axis, on two consecutive examinations at least 1 week apart in an eye to be treated. * Provide signed written consent prior to participation in any study-related procedures. * Ability, comprehension, and willingness to follow study instructions, and to complete all study visits. * Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
Exclusion criteria
* · Subjects with irregular corneal astigmatism in the study eye (Note: corneal incisions intended to reduce astigmatism are not permitted) * Subjects with clinically significant corneal pathology potentially affecting corneal topography in the study eye. * Subjects with a traumatic cataract in the study eye. * Subjects with uncontrolled glaucoma in the study eye. * Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 0.2 logMAR or worse in the study eye. * Subjects with conditions associated with increased risk of zonular rupture during the cataract extraction procedure which may affect the postoperative centration or tilt of the lens in the study eye. * Significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome) in the study eye. * Reasonably expected to require secondary ocular surgical intervention or laser treatment other than YAG capsulotomy in study eye during the study participation period. * Presence of one or more clinically significant corneal abnormalities in study eye, including corneal dystrophy, irregularity, or edema. * Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK, astigmatic keratotomy and limbal relaxing incisions in the study eye. * Clinically significant ocular inflammation or infection present ≤ 30 days in either eye prior to the Preoperative Visit. * Subjects with potential BCDVA of 20/200 or worse in the fellow eye. * Subjects with a difference of greater than 0.50 D of corneal astigmatism as measured with the IOL master/Lenstar/Argos and the topographer in the study eye using vector analysis. * Presence or history of one or more severe/serious ocular conditions (e.g., glaucoma, uveitis, ocular infection, severe dry eye) in the study eye, or any other unstable medical condition (e.g., uncontrolled diabetes) that in the opinion of the Investigator would put the subject's health at risk, confound the results of the study and/or prevent the subject from completing all study visits. * Use of medications known to interfere with visual performance, pupil dilation, or iris structure ≤ 30 days prior to the Preoperative Visit. * Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period. * Pregnant or nursing females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Residual Manifest Cylinder in Diopters in Toric and Control Arms. | Form 4 visit (window: 120-180 days) | Residual Cylinder in Diopters as measured by Manifest Refraction |
| Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than 10 Degrees (Toric IOL Arm Only) | Form 4 visit (window: 120-180 days) | Intraocular lens (IOL) axis misalignment of less than 10 degrees at 4 to 6 months compared to the intended IOL axis of orientation at the operative visit after the surgery |
| Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than 20 Degrees (Toric IOL Arm Only) | Form 4 visit (window: 120-180 days) | Intraocular lens (IOL) axis misalignment of less than 20 degrees at 4 to 6 months compared to the intended IOL axis of orientation at the operative visit after the surgery |
| Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than or Equal to 5 Degrees (Toric IOL Arm Only) | Form 3 Visit (window: 30-60 days), Form 4 Visit (window: 120-180 days) | Intraocular Lens (IOL) rotation of less than or equal to five degrees between Form 3 visit (window: 30-60 days) and Form 4 visit (window: 120-180 days) |
Participant flow
Recruitment details
Subjects were recruited from 9 investigative sites located in the United States.
Pre-assignment details
Of the 261 enrolled, 31 exited as screen failures prior to randomization. A total of 230 participants were randomized in a ratio of 1:1 to receive either the PODEYE TORIC Intraocular lens (IOL) or the AcrySof SA60AT Monofocal IOL (control) in the study eye (unilaterally). 5 participants discontinued after randomization but before implantation. A total of 225 participants were implanted unilaterally with either PODEYE TORIC IOL or the control IOL.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 69.0 years STANDARD_DEVIATION 8.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 110 Participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 88 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 / 112 | 0 / 113 | 0 / 112 | 0 / 113 |
| other Total, other adverse events | 37 / 112 | 61 / 113 | 0 / 112 | 0 / 113 |
| serious Total, serious adverse events | 1 / 112 | 1 / 113 | 1 / 112 | 0 / 113 |
Outcome results
None listed