Trial Outcomes & Findings for Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT) (NCT NCT00759668)

NCT ID: NCT00759668

Last Updated: 2011-01-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

6 months after second eye implantation

Results posted on

2011-01-26

Participant Flow

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.

Patients meeting the inclusion/exclusion criteria were enrolled.

Participant milestones

Participant milestones
Measure	SN60D3 Intraocular Lens Acrysof Natural Restor SN60D3	SN60AT Intraocular Lens Acrysof Natural Monofocal SN60AT
Overall Study STARTED	17	18
Overall Study COMPLETED	16	15
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SN60D3 n=17 Participants Intraocular Lens Acrysof Natural Restor SN60D3	SN60AT n=18 Participants Intraocular Lens Acrysof Natural Monofocal SN60AT	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after second eye implantation

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SN60D3 n=16 Participants Intraocular Lens Acrysof Natural Restor SN60D3	SN60AT n=16 Participants Intraocular Lens Acrysof Natural Monofocal SN60AT
Near Best Corrected Visual Acuity (BCVA) - Binocular	87.5 Percentage of Participants	100 Percentage of Participants

PRIMARY outcome

Timeframe: 6 months after second eye implantation

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SN60D3 n=16 Participants Intraocular Lens Acrysof Natural Restor SN60D3	SN60AT n=16 Participants Intraocular Lens Acrysof Natural Monofocal SN60AT
Near Uncorrected Visual Acuity (UCVA) Binocular	100 Percentage of Participants	31.25 Percentage of Participants

PRIMARY outcome

Timeframe: 6 months after second eye implantation

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SN60D3 n=16 Participants Intraocular Lens Acrysof Natural Restor SN60D3	SN60AT n=16 Participants Intraocular Lens Acrysof Natural Monofocal SN60AT
Near Best Corrected Visual Acuity Left Eye (BCVA LE)	87.5 Percentage of Participants	100 Percentage of Participants

PRIMARY outcome

Timeframe: 6 months after second eye implantation

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SN60D3 n=16 Participants Intraocular Lens Acrysof Natural Restor SN60D3	SN60AT n=16 Participants Intraocular Lens Acrysof Natural Monofocal SN60AT
Near Uncorrected Visual Acuity Left Eye (UCVA LE)	100 Percentage of Participants	18.75 Percentage of Participants

PRIMARY outcome

Timeframe: 6 months after second eye implantation

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SN60D3 n=16 Participants Intraocular Lens Acrysof Natural Restor SN60D3	SN60AT n=16 Participants Intraocular Lens Acrysof Natural Monofocal SN60AT
Near Best Corrected Visual Acuity Right Eye (BCVA RE)	68.75 Percentage of Participants	100 Percentage of Participants

PRIMARY outcome

Timeframe: 6 months after second eye implantation

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SN60D3 n=16 Participants Intraocular Lens Acrysof Natural Restor SN60D3	SN60AT n=16 Participants Intraocular Lens Acrysof Natural Monofocal SN60AT
Near Uncorrected Visual Acuity Right Eye (UCVA RE)	100 Percentage of Participants	25 Percentage of Participants

Adverse Events

SN60D3

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

SN60AT

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SN60D3 n=17 participants at risk Intraocular Lens Acrysof Natural Restor SN60D3	SN60AT n=18 participants at risk；n=118 participants at risk Intraocular Lens Acrysof Natural Monofocal SN60AT
Vascular disorders Aortic aneurysm	5.9% 1/17 • Number of events 1 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)	0.00% 0/18 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/17 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)	5.6% 1/18 • Number of events 1 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)

Other adverse events

Other adverse events
Measure	SN60D3 n=17 participants at risk Intraocular Lens Acrysof Natural Restor SN60D3	SN60AT n=18 participants at risk；n=118 participants at risk Intraocular Lens Acrysof Natural Monofocal SN60AT
Injury, poisoning and procedural complications Lower limb fracture	5.9% 1/17 • Number of events 1 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)	0.00% 0/18 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)
Gastrointestinal disorders hernia hiatal	5.9% 1/17 • Number of events 1 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)	0.00% 0/18 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)
Eye disorders Stenosis and insufficiency of lacrimal passages	0.00% 0/17 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)	5.6% 1/18 • Number of events 1 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)
Eye disorders Corneal membrane disorder NOS	0.00% 0/17 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)	5.6% 1/18 • Number of events 1 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)
Psychiatric disorders Depression	0.00% 0/17 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)	5.6% 1/18 • Number of events 1 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)
Psychiatric disorders Anxiety	0.00% 0/17 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)	5.6% 1/18 • Number of events 1 • Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)

Additional Information

Marcello Fornoni

Alcon Italia SpA

Phone: 39.02.81.303.226

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER