Trial Outcomes & Findings for A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients (NCT NCT01684007)
NCT ID: NCT01684007
Last Updated: 2015-06-22
Results Overview
Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.
COMPLETED
NA
112 participants
Day 90 from second eye implantation
2015-06-22
Participant Flow
Subjects were recruited from 8 investigative sites located outside the USA, including Argentina (1), Chile (1), Germany (2), Netherlands (2), and Spain (2).
Of the 112 subjects enrolled, 9 were discontinued prior to randomization as screen failures. This reporting group includes all implanted subjects (103).
Participant milestones
| Measure |
Bilateral
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
|
Contralateral
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
50
|
|
Overall Study
COMPLETED
|
53
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients
Baseline characteristics by cohort
| Measure |
Bilateral
n=53 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
|
Contralateral
n=50 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 7.9 • n=99 Participants
|
65.9 years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
66.6 years
STANDARD_DEVIATION 9.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
12 participants
n=99 Participants
|
9 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
11 participants
n=99 Participants
|
12 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Region of Enrollment
Argentina
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Region of Enrollment
Chile
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 90 from second eye implantationPopulation: This analysis population includes all subjects with both eyes implanted.
Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.
Outcome measures
| Measure |
Bilateral
n=53 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
|
Contralateral
n=50 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
|
|---|---|---|
|
Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)
|
0.13 logMAR
Standard Deviation 0.148
|
0.09 logMAR
Standard Deviation 0.133
|
SECONDARY outcome
Timeframe: Day 90 from second eye implantationPopulation: This analysis population includes all subjects with both eyes implanted.
VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.
Outcome measures
| Measure |
Bilateral
n=53 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
|
Contralateral
n=50 Participants
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
|
|---|---|---|
|
Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)
|
0.26 logMAR
Standard Deviation 0.158
|
0.10 logMAR
Standard Deviation 0.134
|
Adverse Events
Bilateral
Contralateral
Serious adverse events
| Measure |
Bilateral
n=53 participants at risk
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
|
Contralateral
n=50 participants at risk
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/53 • Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the medical device. AEs were collected as solicited comments and as observations by the study Investigator as outlined in the protocol.
|
2.0%
1/50 • Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the medical device. AEs were collected as solicited comments and as observations by the study Investigator as outlined in the protocol.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/53 • Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the medical device. AEs were collected as solicited comments and as observations by the study Investigator as outlined in the protocol.
|
2.0%
1/50 • Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the medical device. AEs were collected as solicited comments and as observations by the study Investigator as outlined in the protocol.
|
Other adverse events
| Measure |
Bilateral
n=53 participants at risk
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
|
Contralateral
n=50 participants at risk
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
5.7%
3/53 • Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the medical device. AEs were collected as solicited comments and as observations by the study Investigator as outlined in the protocol.
|
6.0%
3/50 • Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the medical device. AEs were collected as solicited comments and as observations by the study Investigator as outlined in the protocol.
|
Additional Information
Magda Michna, Expert Clinical Lead, Surgical
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER