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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORA with VerifEye+ | Experimental | First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group. |
|
| Barrett Toric Calculator | Active Comparator | First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORA with VerifEye+ | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Operations Lead, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Mt. Dora | Florida | 32757 | United States | ||
| Alcon Investigative Site |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | First surgical eye randomly assigned to Acrysof® IQ Toric IOL and Optiwave Refractive Analysis with VerifEye+ (ORA With VerifEye+) or Acrysof® IQ Toric IOL and Barrett Toric Calculator (Barrett Toric Calculator), with the second surgical eye (fellow eye) assigned to the alternative group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percentage of eyes | Month 6 | eyes | eyes |
|
Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days.
Adverse events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. "At Risk" population for ocular adverse events is included with unit of "eyes."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pretreatment | All subjects prior to with attempted implantation with any IOL (successful or aborted after contact with the eye) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metamorphopsia | Eye disorders | MedDRA (21.0) | Systematic Assessment | Assessed as not related to the Barrett Toric Calculator |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior capsule opacification | Eye disorders | MedDRA (21.0) | Systematic Assessment | Assessed as not related to the ORA with VerifEye or Barrett Toric Calculator |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. CDMA Project Lead, Surgical | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2019 | Mar 19, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 22, 2019 | Mar 19, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| Alcon Barrett Toric Calculator | Other | 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. |
|
| Acrysof® IQ Toric IOL | Device | Intraocular lens implanted as a replacement for the cataractous lens during cataract surgery (Model SN6AT3, SN6AT4, Model SN6AT5, Model SN6AT6) |
|
| Panama City |
| Florida |
| 32405 |
| United States |
| Alcon Investigative Site | Poughkeepsie | New York | 12603 | United States |
| Alcon Investigative Site | Kingston | Pennsylvania | 18704 | United States |
| Alcon Investigative Site | Florence | South Carolina | 29501 | United States |
| Alcon Investigative Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Alcon Investigative Site | Sioux Falls | South Dakota | 57108 | United States |
| Alcon Investigative Site | Nashville | Tennessee | 37205 | United States |
| Alcon Investigative Site | Nacogdoches | Texas | 75965 | United States |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Barrett Toric Calculator |
Acrysof® IQ Toric IOL and Barrett Toric Calculator |
|
|
| 0 |
| 104 |
| 0 |
| 104 |
| 0 |
| 104 |
| EG001 | ORA With VerifEye+ Study Eye | All eyes with attempted implantation (successful or aborted after contact with the eye) of Acrysof® IQ Toric IOL and ORA with VerifEye+ | 0 | 96 | 2 | 96 | 10 | 96 |
| EG002 | Barrett Toric Calculator Study Eye | All eyes with attempted implantation (successful or aborted after contact with the eye) of Acrysof® IQ Toric IOL and Barrett Toric Calculator | 0 | 102 | 2 | 102 | 7 | 102 |
| EG003 | Overall Systemic | All subjects with attempted implantation with any IOL (successful or aborted after contact with the eye) | 0 | 104 | 1 | 104 | 0 | 104 |
|
| Retinal detachment | Eye disorders | MedDRA (21.0) | Systematic Assessment | Assessed as not related to the ORA With VerifEye |
|
| Retinal tear | Eye disorders | MedDRA (21.0) | Systematic Assessment | Assessed as not related to the ORA With VerifEye |
|
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Eye laser surgery | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment | Assessed as not related to the ORA With VerifEye |
|
| Intraocular lens implant | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment | Assessed as not related to the Barrett Toric Calculator |
|
| Intraocular lens repositioning | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment | Assessed as not related to the Barrett Toric Calculator |
|
|
| Intraocular pressure increased | Investigations | MedDRA (21.0) | Systematic Assessment | Assessed as not related to the ORA with VerifEye or Barrett Toric Calculator |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.