Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00759668
Collaborator
(none)
35
Enrollment
1
Location
2
Arms
28.1
Duration (Months)
1.2
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Device: Acrysof Natural ReSTOR SN60D3
  • Device: Acrysof Natural Monofocal SN60AT
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Sep 1, 2009
Actual Study Completion Date :
Sep 1, 2009

Arms and Interventions

ArmIntervention/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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

SiteCityStateCountryPostal Code
1Contact Alcon Call Center for Trial LocationsFort WorthTexasUnited States76134

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00759668
Other Study ID Numbers:
  • IT 06 01
First Posted:
Sep 25, 2008
Last Update Posted:
Jan 26, 2011
Last Verified:
Jan 1, 2011
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details35 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 DetailPatients meeting the inclusion/exclusion criteria were enrolled.
Arm/Group TitleSN60D3SN60AT
Arm/Group DescriptionIntraocular Lens Acrysof Natural Restor SN60D3Intraocular Lens Acrysof Natural Monofocal SN60AT
Period Title: Overall Study
STARTED1718
COMPLETED1615
NOT COMPLETED13

Baseline Characteristics

Arm/Group TitleSN60D3SN60ATTotal
Arm/Group DescriptionIntraocular Lens Acrysof Natural Restor SN60D3Intraocular Lens Acrysof Natural Monofocal SN60ATTotal of all reporting groups
Overall Participants171835
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

1. Primary Outcome
TitleNear Best Corrected Visual Acuity (BCVA) - Binocular
DescriptionPercentage 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 Frame6 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 TitleSN60D3SN60AT
Arm/Group DescriptionIntraocular Lens Acrysof Natural Restor SN60D3Intraocular Lens Acrysof Natural Monofocal SN60AT
Measure Participants1616
Number [Percentage of Participants]
87.5
514.7%
100
555.6%
2. Primary Outcome
TitleNear Uncorrected Visual Acuity (UCVA) Binocular
DescriptionPercentage 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 Frame6 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 TitleSN60D3SN60AT
Arm/Group DescriptionIntraocular Lens Acrysof Natural Restor SN60D3Intraocular Lens Acrysof Natural Monofocal SN60AT
Measure Participants1616
Number [Percentage of Participants]
100
588.2%
31.25
173.6%
3. Primary Outcome
TitleNear Best Corrected Visual Acuity Left Eye (BCVA LE)
DescriptionPercentage 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 Frame6 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 TitleSN60D3SN60AT
Arm/Group DescriptionIntraocular Lens Acrysof Natural Restor SN60D3Intraocular Lens Acrysof Natural Monofocal SN60AT
Measure Participants1616
Number [Percentage of Participants]
87.5
514.7%
100
555.6%
4. Primary Outcome
TitleNear Uncorrected Visual Acuity Left Eye (UCVA LE)
DescriptionPercentage 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 Frame6 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 TitleSN60D3SN60AT
Arm/Group DescriptionIntraocular Lens Acrysof Natural Restor SN60D3Intraocular Lens Acrysof Natural Monofocal SN60AT
Measure Participants1616
Number [Percentage of Participants]
100
588.2%
18.75
104.2%
5. Primary Outcome
TitleNear Best Corrected Visual Acuity Right Eye (BCVA RE)
DescriptionPercentage 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 Frame6 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 TitleSN60D3SN60AT
Arm/Group DescriptionIntraocular Lens Acrysof Natural Restor SN60D3Intraocular Lens Acrysof Natural Monofocal SN60AT
Measure Participants1616
Number [Percentage of Participants]
68.75
404.4%
100
555.6%
6. Primary Outcome
TitleNear Uncorrected Visual Acuity Right Eye (UCVA RE)
DescriptionPercentage 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 Frame6 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 TitleSN60D3SN60AT
Arm/Group DescriptionIntraocular Lens Acrysof Natural Restor SN60D3Intraocular Lens Acrysof Natural Monofocal SN60AT
Measure Participants1616
Number [Percentage of Participants]
100
588.2%
25
138.9%

Adverse Events

Time FrameVisit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)
Adverse Event Reporting Description
Arm/Group TitleSN60D3SN60AT
Arm/Group DescriptionIntraocular Lens Acrysof Natural Restor SN60D3Intraocular Lens Acrysof Natural Monofocal SN60AT
All Cause Mortality
SN60D3SN60AT
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
SN60D3SN60AT
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/17 (5.9%) 1/118 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer0/17 (0%) 01/18 (5.6%) 1
Vascular disorders
Aortic aneurysm1/17 (5.9%) 10/18 (0%) 0
Other (Not Including Serious) Adverse Events
SN60D3SN60AT
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/17 (11.8%) 3/18 (16.7%)
Eye disorders
Stenosis and insufficiency of lacrimal passages0/17 (0%) 01/18 (5.6%) 1
Corneal membrane disorder NOS0/17 (0%) 01/18 (5.6%) 1
Gastrointestinal disorders
hernia hiatal1/17 (5.9%) 10/18 (0%) 0
Injury, poisoning and procedural complications
Lower limb fracture1/17 (5.9%) 10/18 (0%) 0
Psychiatric disorders
Depression0/17 (0%) 01/18 (5.6%) 1
Anxiety0/17 (0%) 01/18 (5.6%) 1

Limitations/Caveats

Visual acuity data were collected in different units (i.e. c, twentieth, decimal, Jaeger) and were converted to LogMAR after inclusion in the database. This led to inevitable approximations of the data.

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/TitleMarcello Fornoni
OrganizationAlcon Italia SpA
Phone39.02.81.303.226
Emailmarcello.fornoni@alconlabs.com
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00759668
Other Study ID Numbers:
  • IT 06 01
First Posted:
Sep 25, 2008
Last Update Posted:
Jan 26, 2011
Last Verified:
Jan 1, 2011