Cataract
Conditions
Keywords
IOL, Intraocular lens, Astigmatism, Cataract Surgery
Brief summary
The purpose of the study was to evaluate the visual acuity outcomes when using the Optiwave Refractive Analysis (ORA) with VerifEye+ and Barrett Toric Calculator for calculating intraocular lens (IOL) power and axis in subjects requiring cataract surgery and implanted with a toric IOL in both eyes.
Detailed description
Surgery was done on each eye on different days, 7 to 14 days apart. Subjects were seen for a total of 10 visits with a follow-up duration of 6 months.
Interventions
DEVICEORA with VerifEye+
Intraoperative device that measures total corneal astigmatism in the aphakic condition and is used for the selection of IOL power. In the pseudophakic condition, ORA provides guidance for the alignment of the toric axis mark.
OTHERAlcon Barrett Toric Calculator
Web-based software application that utilizes an algorithm (Barrett Formula) to estimate the amount of post-operative corneal astigmatism in order to optimize IOL model selection and axis placement, with interoperative axis alignment done manually.
DEVICEAcrysof® IQ Toric IOL
Intraocular lens implanted as a replacement for the cataractous lens during cataract surgery (Model SN6AT3, SN6AT4, Model SN6AT5, Model SN6AT6)
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned cataract surgery with IOL implantation * Able to comprehend and sign the informed consent form * Preoperative astigmatism of 0.75 to 3.00 Diopter * Willing and able to complete all required postoperative visits * Other protocol-defined inclusion criteria may apply
Exclusion criteria
* Unclear intraocular media other than cataract * Pregnant or lactating * Presence or history of any condition or finding that makes the subject unsuitable as a candidate for cataract surgery or study participation or may confound the outcome of the study, in the opinion of the Investigator. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6 | Month 6 | Visual acuity (VA) was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. 20/20 represents normal distance eyesight. No hypothesis testing of the primary endpoint was specified. |
Countries
United States
Participant flow
Recruitment details
Of the 124 subjects enrolled, 12 subjects were discontinued prior to randomization, and 8 subjects were randomized, but not treated in either eye. This reporting group includes all subjects with attempted implantation of an intraocular lens (IOL) in one or both eyes.
Participants by arm
| Arm | Count |
|---|---|
| Overall First surgical eye randomly assigned to Acrysof® IQ Toric (IOL) and Optiwave Refractive Analysis (ORA) with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group. | 104 |
| Total | 104 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 69.0 years STANDARD_DEVIATION 8.73 |
| Age, Customized 65 years old or older | 76 Participants |
| Age, Customized Less than 65 years old | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 102 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 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 | 96 Participants |
| Region of Enrollment United States | 104 participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 43 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 / 104 | 0 / 96 | 0 / 102 | 0 / 104 |
| other Total, other adverse events | 0 / 104 | 10 / 96 | 7 / 102 | 0 / 104 |
| serious Total, serious adverse events | 0 / 104 | 2 / 96 | 2 / 102 | 1 / 104 |
Outcome results
Primary
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6
Visual acuity (VA) was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. 20/20 represents normal distance eyesight. No hypothesis testing of the primary endpoint was specified.
Time frame: Month 6
Population: The Per Protocol Analysis Set (PPS) includes all eyes with successful IOL implantation, T3-T6 and recommended by ORA and with no major protocol deviations and data at visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ORA With VerifEye+ | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6 | 87.1 percentage of eyes |
| Barrett Toric Calculator | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6 | 87.4 percentage of eyes |