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The purpose of this study is to characterize the safety and effectiveness of the ACRYSOF IQ ReSTOR +2.5 diopter (D) Multifocal Toric Intraocular Lens (IOL) in subjects at least 3 months and no more than 14 months after IOL implantation.
This is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data, and a prospective postoperative visit conducted at least 3 months but not more than 14 months after IOL implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSTOR Toric +2.5 | Experimental | AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL previously implanted during cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL | Device | Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Reduction in Cylinder | Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis. | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
| Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D | Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis. | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
| Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D | Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis. | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
| Mean Uncorrected Distance Visual Acuity | Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, GCRA, Surgical | Alcon Research | Study Director |
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Of the 37 enrolled, 6 subjects were exited as screen failures and were ineligible to participate in the study. This reporting group includes all subjects who provided informed consent and were determined to be eligible based upon the inclusion and exclusion criteria (As Treated) (31).
Subjects were recruited from 4 study centers located in Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | ReSTOR Toric +2.5 | AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lens (IOL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
As Treated
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| ID | Title | Description |
|---|---|---|
| BG000 | ReSTOR Toric +2.5 | AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL |
| 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 | Mean Percent Reduction in Cylinder | Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis. | As Treated | Posted | Mean | Standard Deviation | percent change | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
|
The time period of collection of AEs was preoperative to postoperative visit 3-14 months after IOL implantation. This analysis population includes all subjects who provided informed consent and were determined eligible based upon inclusion and exclusion criteria (As Treated).
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product. AEs were obtained as solicited and volunteered comments from subjects and as observations by the study Investigator as outlined in the study protocol.
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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 | ReSTOR Toric +2.5 | All subjects implanted with AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular oedema | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Photopsia | Eye disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Lead, GCRA, Surgical | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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|
| Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
| Mean Uncorrected Near Visual Acuity | VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis. | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
| Mean Uncorrected Intermediate Visual Acuity | VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis. | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
| Mean Best Corrected Distance Visual Acuity (BCDVA) | VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis. | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
| Mean IOL Rotation | Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis. | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
|
|
| Primary | Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D | Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis. | As Treated | Posted | Number | percentage of subjects | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
|
|
|
| Primary | Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D | Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis. | This analysis population includes all subjects who provided informed consent and were determined eligible based upon the inclusion and exclusion criteria, having preoperative astigmatism > 1.00 D. | Posted | Number | percentage of subjects | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
|
|
|
| Primary | Mean Uncorrected Distance Visual Acuity | Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis. | As Treated | Posted | Mean | Standard Deviation | logMAR | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
|
|
|
| Primary | Mean Uncorrected Near Visual Acuity | VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis. | As Treated | Posted | Mean | Standard Deviation | logMAR | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
|
|
|
| Primary | Mean Uncorrected Intermediate Visual Acuity | VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis. | As Treated | Posted | Mean | Standard Deviation | logMAR | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
|
|
|
| Primary | Mean Best Corrected Distance Visual Acuity (BCDVA) | VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis. | As Treated | Posted | Mean | Standard Deviation | logMAR | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
|
|
|
| Primary | Mean IOL Rotation | Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis. | As Treated | Posted | Mean | Standard Deviation | degrees | Preoperative and Postoperative Visit (3 to 14 months after IOL implantation) |
|
|
|
| 0 |
| 31 |
| 3 |
| 31 |
| 4 |
| 31 |
| Retinal vein occlusion | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Strabismus | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Intra-ocular injection | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA (17.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.