Cataract
Conditions
Keywords
AcrySof, ReSTOR, Aspheric IOL, Cataract
Brief summary
This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.
Interventions
DEVICEAcrySof® ReSTOR® Aspheric IOL
AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 21 years or older; * need spherical correction between 10-30 Diopters (D); * corneal astigmatism less than 0.75D as measured by keratometry; * willing to sign an Informed Consent Form and complete all visits; * pupil dilation greater than 6mm; * expected Visual Acuity (measured in logMAR)=0.3 or better
Exclusion criteria
* Women of childbearing potential; * irregular corneal astigmatism; * keratopathy/keratectasia; * cornea inflammation or edema; * cornea reshaping surgery; * corneal dystrophy;corneal transplant; * amblyopia; * glaucoma; * Retinal Pigment Epitheliopathy (RPE)/Macular changes; * proliferative diabetic retinopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery | Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spectacle Independence | pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery | Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported. |
Countries
United States
Participant flow
Recruitment details
Subjects \>21 years of age, either sex, and any race. Diagnosis of cataracts in both eyes. 27-Jun-2007 to 20-May-2009
Pre-assignment details
Subject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| AcrySof® ReSTOR® Aspheric IOL AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) | 76 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 2nd Intraoperative exclusion criteria | 1 |
| Overall Study | Lost to Follow-up | 7 |
Baseline characteristics
| Characteristic | AcrySof® ReSTOR® Aspheric IOL |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 43 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants |
| Gender Female | 48 participants |
| Gender Male | 27 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 76 |
| serious Total, serious adverse events | 0 / 76 |
Outcome results
Primary
Visual Acuity
Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity.
Time frame: pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AcrySof® ReSTOR® Aspheric IOL | Visual Acuity | Preoperative | 0.54 logMAR | Standard Deviation 0.3 |
| AcrySof® ReSTOR® Aspheric IOL | Visual Acuity | 1 Week | 0.06 logMAR | Standard Deviation 0.12 |
| AcrySof® ReSTOR® Aspheric IOL | Visual Acuity | 1 Month | 0.03 logMAR | Standard Deviation 0.08 |
| AcrySof® ReSTOR® Aspheric IOL | Visual Acuity | 3 Months | 0.04 logMAR | Standard Deviation 0.08 |
| AcrySof® ReSTOR® Aspheric IOL | Visual Acuity | 6 Months | 0.05 logMAR | Standard Deviation 0.09 |
Secondary
Spectacle Independence
Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.
Time frame: pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery
Population: Patient population was not consistent throughout the study. Number of patients analyzed at each visit is as follows: Preoperative n=76, Week 1 n=61, 1 Month n=71, 3 Months n=70, 6 Months n=68.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AcrySof® ReSTOR® Aspheric IOL | Spectacle Independence | Preoperative | 29 Percentage of Participants |
| AcrySof® ReSTOR® Aspheric IOL | Spectacle Independence | 1 Week Postoperative | 96.8 Percentage of Participants |
| AcrySof® ReSTOR® Aspheric IOL | Spectacle Independence | 1 Month Postoperative | 97.2 Percentage of Participants |
| AcrySof® ReSTOR® Aspheric IOL | Spectacle Independence | 3 Months Postoperative | 98.6 Percentage of Participants |
| AcrySof® ReSTOR® Aspheric IOL | Spectacle Independence | 6 Months Postoperative | 100 Percentage of Participants |