Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
Study Details
Study Description
Brief Summary
The purpose of the study is:
-
to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
-
to assess patient satisfaction before and after implant
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SN60D3 AcrySof Natural ReSTOR Intraocular Lens (IOL) Model SN60D3 |
Device: Acrysof Natural ReSTOR SN60D3
Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.
|
| Active Comparator: SN60AT AcrySof Natural Monofocal Intraocular Lens (IOL) Model SN60AT |
Device: Acrysof Natural Monofocal SN60AT
Bilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.
|
Outcome Measures
Primary Outcome Measures
- Near Best Corrected Visual Acuity (BCVA) - Binocular [6 months after second eye implantation]
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
- Near Uncorrected Visual Acuity (UCVA) Binocular [6 months after second eye implantation]
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
- Near Best Corrected Visual Acuity Left Eye (BCVA LE) [6 months after second eye implantation]
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
- Near Uncorrected Visual Acuity Left Eye (UCVA LE) [6 months after second eye implantation]
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
- Near Best Corrected Visual Acuity Right Eye (BCVA RE) [6 months after second eye implantation]
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
- Near Uncorrected Visual Acuity Right Eye (UCVA RE) [6 months after second eye implantation]
Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Eligibility Criteria
Criteria
Inclusion:
-
Written informed consent
-
Age: ≥ 50 years ≤ 75 years
-
Bilateral age related cataract, to be extracted and followed by the implantation of Posterior Chamber Intraocular Lenses (IOLs)
-
Pre-operative and post-operative astigmatism ≤ 1 Diopter (D), as from Keratometry readings
-
Potential post operative Visual Acuity (VA) ≥ 20/40
-
Second eye surgery to take place no longer than 45 days after the first implant
Exclusion:
-
Irregular optical aberrations;
-
Pupil diameter in scotopic conditions more than 6 mm
-
Degenerative visual pathologies (ex: Age-related Macular Degeneration (AMD))
-
Other exclusions as from ReSTOR Directions for Use (DFU)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | United States | 76134 |
Sponsors and Collaborators
- Alcon Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IT 06 01
Study Results
Participant Flow
| Recruitment Details | 35 patients, diagnosed with bilateral cataracts age related, requiring extraction of cataracts in both eyes followed by implantation of a posterior chamber intraocular lens, were recruited. |
|---|---|
| Pre-assignment Detail | Patients meeting the inclusion/exclusion criteria were enrolled. |
| Arm/Group Title | SN60D3 | SN60AT |
|---|---|---|
| Arm/Group Description | Intraocular Lens Acrysof Natural Restor SN60D3 | Intraocular Lens Acrysof Natural Monofocal SN60AT |
| Period Title: Overall Study | ||
| STARTED | 17 | 18 |
| COMPLETED | 16 | 15 |
| NOT COMPLETED | 1 | 3 |
Baseline Characteristics
| Arm/Group Title | SN60D3 | SN60AT | Total |
|---|---|---|---|
| Arm/Group Description | Intraocular Lens Acrysof Natural Restor SN60D3 | Intraocular Lens Acrysof Natural Monofocal SN60AT | Total of all reporting groups |
| Overall Participants | 17 | 18 | 35 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
3
17.6%
|
6
33.3%
|
9
25.7%
|
| >=65 years |
14
82.4%
|
12
66.7%
|
26
74.3%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
10
58.8%
|
11
61.1%
|
21
60%
|
| Male |
7
41.2%
|
7
38.9%
|
14
40%
|
Outcome Measures
| Title | Near Best Corrected Visual Acuity (BCVA) - Binocular |
|---|---|
| Description | Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA. |
| Time Frame | 6 months after second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations. |
| Arm/Group Title | SN60D3 | SN60AT |
|---|---|---|
| Arm/Group Description | Intraocular Lens Acrysof Natural Restor SN60D3 | Intraocular Lens Acrysof Natural Monofocal SN60AT |
| Measure Participants | 16 | 16 |
| Number [Percentage of Participants] |
87.5
514.7%
|
100
555.6%
|
| Title | Near Uncorrected Visual Acuity (UCVA) Binocular |
|---|---|
| Description | Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA. |
| Time Frame | 6 months after second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations. |
| Arm/Group Title | SN60D3 | SN60AT |
|---|---|---|
| Arm/Group Description | Intraocular Lens Acrysof Natural Restor SN60D3 | Intraocular Lens Acrysof Natural Monofocal SN60AT |
| Measure Participants | 16 | 16 |
| Number [Percentage of Participants] |
100
588.2%
|
31.25
173.6%
|
| Title | Near Best Corrected Visual Acuity Left Eye (BCVA LE) |
|---|---|
| Description | Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA. |
| Time Frame | 6 months after second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations. |
| Arm/Group Title | SN60D3 | SN60AT |
|---|---|---|
| Arm/Group Description | Intraocular Lens Acrysof Natural Restor SN60D3 | Intraocular Lens Acrysof Natural Monofocal SN60AT |
| Measure Participants | 16 | 16 |
| Number [Percentage of Participants] |
87.5
514.7%
|
100
555.6%
|
| Title | Near Uncorrected Visual Acuity Left Eye (UCVA LE) |
|---|---|
| Description | Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA. |
| Time Frame | 6 months after second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations. |
| Arm/Group Title | SN60D3 | SN60AT |
|---|---|---|
| Arm/Group Description | Intraocular Lens Acrysof Natural Restor SN60D3 | Intraocular Lens Acrysof Natural Monofocal SN60AT |
| Measure Participants | 16 | 16 |
| Number [Percentage of Participants] |
100
588.2%
|
18.75
104.2%
|
| Title | Near Best Corrected Visual Acuity Right Eye (BCVA RE) |
|---|---|
| Description | Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA. |
| Time Frame | 6 months after second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations. |
| Arm/Group Title | SN60D3 | SN60AT |
|---|---|---|
| Arm/Group Description | Intraocular Lens Acrysof Natural Restor SN60D3 | Intraocular Lens Acrysof Natural Monofocal SN60AT |
| Measure Participants | 16 | 16 |
| Number [Percentage of Participants] |
68.75
404.4%
|
100
555.6%
|
| Title | Near Uncorrected Visual Acuity Right Eye (UCVA RE) |
|---|---|
| Description | Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA. |
| Time Frame | 6 months after second eye implantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations. |
| Arm/Group Title | SN60D3 | SN60AT |
|---|---|---|
| Arm/Group Description | Intraocular Lens Acrysof Natural Restor SN60D3 | Intraocular Lens Acrysof Natural Monofocal SN60AT |
| Measure Participants | 16 | 16 |
| Number [Percentage of Participants] |
100
588.2%
|
25
138.9%
|
Adverse Events
| Time Frame | Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | SN60D3 | SN60AT | ||
| Arm/Group Description | Intraocular Lens Acrysof Natural Restor SN60D3 | Intraocular Lens Acrysof Natural Monofocal SN60AT | ||
All Cause Mortality |
||||
| SN60D3 | SN60AT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| SN60D3 | SN60AT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/17 (5.9%) | 1/118 (0.8%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Breast cancer | 0/17 (0%) | 0 | 1/18 (5.6%) | 1 |
| Vascular disorders | ||||
| Aortic aneurysm | 1/17 (5.9%) | 1 | 0/18 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| SN60D3 | SN60AT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/17 (11.8%) | 3/18 (16.7%) | ||
| Eye disorders | ||||
| Stenosis and insufficiency of lacrimal passages | 0/17 (0%) | 0 | 1/18 (5.6%) | 1 |
| Corneal membrane disorder NOS | 0/17 (0%) | 0 | 1/18 (5.6%) | 1 |
| Gastrointestinal disorders | ||||
| hernia hiatal | 1/17 (5.9%) | 1 | 0/18 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Lower limb fracture | 1/17 (5.9%) | 1 | 0/18 (0%) | 0 |
| Psychiatric disorders | ||||
| Depression | 0/17 (0%) | 0 | 1/18 (5.6%) | 1 |
| Anxiety | 0/17 (0%) | 0 | 1/18 (5.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Any formal presentation of data publication from this study has to be a joint presentation from both the Investigators and the Sponsor. Being the study multicentric, it is mandatory that the first publication is based on data from all the centres, analysed according to the protocol. Data from a single Centre can not be presented, unless there is a formal agreement from the other Investigators and Alcon.
Results Point of Contact
| Name/Title | Marcello Fornoni |
|---|---|
| Organization | Alcon Italia SpA |
| Phone | 39.02.81.303.226 |
| marcello.fornoni@alconlabs.com |
- IT 06 01