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The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSTOR +3 | Experimental | Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL) |
|
| Crystalens HD | Active Comparator | Bilateral implantation of Crystalens HD Intraocular Lens (IOL) |
|
| Crystalens AO | Active Comparator | Bilateral implantation of Crystalens AO Intraocular Lens (IOL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReSTOR +3 | Device | Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity | Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm. | 6 Months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center For Trial Locations | Fort Worth | Texas | 76134 | United States |
During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.
Bilateral diagnosis of cataracts of subjects >21 years of age.
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| ID | Title | Description |
|---|---|---|
| FG000 | ReSTOR +3 | Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL) |
| FG001 | Crystalens HD | Bilateral implantation of Crystalens HD Intraocular Lens (IOL) |
| FG002 | Crystalens AO | Bilateral implantation of Crystalens AO Intraocular Lens (IOL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ReSTOR +3 | Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL) |
| BG001 | Crystalens HD | Bilateral implantation of Crystalens HD Intraocular Lens (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 | Best Corrected Visual Acuity | Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm. | 2 ReSTOR +3 subjects and 1 Crystalens HD subject missed their final visits and were not included in this analysis. | Posted | Mean | Standard Deviation | logMAR | 6 Months after surgery |
|
Day of surgery until visit 6 months following surgery.
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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 +3 | Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical | Alcon Research, Ltd. | 888-451-3937; 817-568-6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Crystalens HD | Device | Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract. |
|
| Crystalens AO | Device | Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract. |
|
| BG002 | Crystalens AO | Bilateral implantation of Crystalens AO Intraocular Lens (IOL) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Crystalens HD |
Bilateral implantation of Crystalens HD Intraocular Lens (IOL) |
| OG002 | Crystalens AO | Bilateral implantation of Crystalens AO Intraocular Lens (IOL) |
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Crystalens HD | Bilateral implantation of Crystalens HD Intraocular Lens (IOL) | 0 | 44 | 0 | 44 |
| EG002 | Crystalens AO | Bilateral implantation of Crystalens AO Intraocular Lens (IOL) | 0 | 41 | 0 | 41 |
All data and discoveries arising out of the study, patentable or nonpatentable, shall be the sole property of Alcon Laboratories, Inc. Alcon reserves the right of prior review of any publication or presentation of information related to the study. Alcon may use these data now and in the future for presentation or publication at Alcon's discretion or for submission to government regulatory agencies.