Trial Outcomes & Findings for A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs) (NCT NCT01257217)
NCT ID: NCT01257217
Last Updated: 2018-07-02
Results Overview
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
COMPLETED
NA
31 participants
Month 3 from second eye implantation
2018-07-02
Participant Flow
Subjects were recruited from one investigative site located in Spain.
Of the 31 enrolled participants, 1 exited prior to randomization due to withdrawn consent and 5 discontinued after randomization due to adverse event (1) and protocol deviation (4). This reporting group includes all randomized participants who received IOLs without major deviations and/or surgical complications (efficacy population).
Participant milestones
| Measure |
ReSTOR +3
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
|
Acri.LISA
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
10
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)
Baseline characteristics by cohort
| Measure |
ReSTOR +3
n=15 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
|
Acri.LISA
n=10 Participants
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 21 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
≥ 21 years
|
15 participants
n=5 Participants
|
10 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
15 participants
n=5 Participants
|
10 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3 from second eye implantationPopulation: This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Outcome measures
| Measure |
ReSTOR +3
n=13 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
|
Acri.LISA
n=10 Participants
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
|
Acri.LISA/Without
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
|
Acri.LISA/With
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
|
|---|---|---|---|---|
|
Mean Binocular Defocus VA at Month 3
-5.00 diopter
|
0.78 logMAR
Standard Deviation 0.26
|
0.59 logMAR
Standard Deviation 0.18
|
—
|
—
|
|
Mean Binocular Defocus VA at Month 3
-4.50 diopter
|
0.65 logMAR
Standard Deviation 0.18
|
0.45 logMAR
Standard Deviation 0.17
|
—
|
—
|
|
Mean Binocular Defocus VA at Month 3
-4.00 diopter
|
0.58 logMAR
Standard Deviation 0.19
|
0.29 logMAR
Standard Deviation 0.13
|
—
|
—
|
|
Mean Binocular Defocus VA at Month 3
-3.50 diopter
|
0.36 logMAR
Standard Deviation 0.13
|
0.18 logMAR
Standard Deviation 0.14
|
—
|
—
|
|
Mean Binocular Defocus VA at Month 3
-3.00 diopter
|
0.15 logMAR
Standard Deviation 0.07
|
0.11 logMAR
Standard Deviation 0.21
|
—
|
—
|
|
Mean Binocular Defocus VA at Month 3
-2.50 diopter
|
0.04 logMAR
Standard Deviation 0.08
|
0.08 logMAR
Standard Deviation 0.20
|
—
|
—
|
|
Mean Binocular Defocus VA at Month 3
-2.00 diopter
|
0.14 logMAR
Standard Deviation 0.13
|
0.20 logMAR
Standard Deviation 0.18
|
—
|
—
|
|
Mean Binocular Defocus VA at Month 3
-1.50 diopter
|
0.30 logMAR
Standard Deviation 0.11
|
0.33 logMAR
Standard Deviation 0.18
|
—
|
—
|
|
Mean Binocular Defocus VA at Month 3
-1.00 diopter
|
0.23 logMAR
Standard Deviation 0.10
|
0.22 logMAR
Standard Deviation 0.16
|
—
|
—
|
|
Mean Binocular Defocus VA at Month 3
-0.50 diopter
|
0.07 logMAR
Standard Deviation 0.06
|
0.07 logMAR
Standard Deviation 0.11
|
—
|
—
|
|
Mean Binocular Defocus VA at Month 3
0.00 diopter
|
-0.02 logMAR
Standard Deviation 0.07
|
-0.05 logMAR
Standard Deviation 0.14
|
—
|
—
|
|
Mean Binocular Defocus VA at Month 3
+0.50 diopter
|
0.06 logMAR
Standard Deviation 0.08
|
0.06 logMAR
Standard Deviation 0.18
|
—
|
—
|
|
Mean Binocular Defocus VA at Month 3
+1.00 diopter
|
0.26 logMAR
Standard Deviation 0.11
|
0.21 logMAR
Standard Deviation 0.16
|
—
|
—
|
|
Mean Binocular Defocus VA at Month 3
+1.50 diopter
|
0.54 logMAR
Standard Deviation 0.21
|
0.37 logMAR
Standard Deviation 0.19
|
—
|
—
|
|
Mean Binocular Defocus VA at Month 3
+2.00 diopter
|
0.63 logMAR
Standard Deviation 0.23
|
0.51 logMAR
Standard Deviation 0.16
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 3 from second eye implantationPopulation: This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
Visual acuity (VA) was tested binocularly (both eyes together) with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Outcome measures
| Measure |
ReSTOR +3
n=13 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
|
Acri.LISA
n=10 Participants
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
|
Acri.LISA/Without
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
|
Acri.LISA/With
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
|
|---|---|---|---|---|
|
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3
Far distance 4 meters (m)
|
-0.02 logMAR
Standard Deviation 0.08
|
-0.05 logMAR
Standard Deviation 0.15
|
—
|
—
|
|
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3
Intermediate 70 centimeters (cm)
|
0.39 logMAR
Standard Deviation 0.11
|
0.35 logMAR
Standard Deviation 0.09
|
—
|
—
|
|
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3
Intermediate 60 cm
|
0.33 logMAR
Standard Deviation 0.10
|
0.35 logMAR
Standard Deviation 0.09
|
—
|
—
|
|
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3
Intermediate 50 cm
|
0.24 logMAR
Standard Deviation 0.11
|
0.28 logMAR
Standard Deviation 0.11
|
—
|
—
|
|
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3
Near 33/40 cm
|
0.19 logMAR
Standard Deviation 0.13
|
0.20 logMAR
Standard Deviation 0.15
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 3 from second eye implantationPopulation: This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
VA was tested binocularly unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Outcome measures
| Measure |
ReSTOR +3
n=13 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
|
Acri.LISA
n=10 Participants
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
|
Acri.LISA/Without
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
|
Acri.LISA/With
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
|
|---|---|---|---|---|
|
Uncorrected Visual Acuity Across a Range of Distances at Month 3
Intermediate 60 cm
|
0.36 logMAR
Standard Deviation 0.16
|
0.33 logMAR
Standard Deviation 0.12
|
—
|
—
|
|
Uncorrected Visual Acuity Across a Range of Distances at Month 3
Intermediate 50 cm
|
0.29 logMAR
Standard Deviation 0.19
|
0.33 logMAR
Standard Deviation 0.12
|
—
|
—
|
|
Uncorrected Visual Acuity Across a Range of Distances at Month 3
Far distance 4 meters (m)
|
0.14 logMAR
Standard Deviation 0.20
|
0.03 logMAR
Standard Deviation 0.16
|
—
|
—
|
|
Uncorrected Visual Acuity Across a Range of Distances at Month 3
Intermediate 70 centimeters (cm)
|
0.37 logMAR
Standard Deviation 0.15
|
0.27 logMAR
Standard Deviation 0.14
|
—
|
—
|
|
Uncorrected Visual Acuity Across a Range of Distances at Month 3
Near 33/40 cm
|
0.27 logMAR
Standard Deviation 0.18
|
0.28 logMAR
Standard Deviation 0.12
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 3 from second eye implantationPopulation: This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean.
Outcome measures
| Measure |
ReSTOR +3
n=13 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
|
Acri.LISA
n=10 Participants
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
|
Acri.LISA/Without
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
|
Acri.LISA/With
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
|
|---|---|---|---|---|
|
Mean Refractive Spherical Equivalent at Month 3
|
0.1 diopter
Standard Deviation 0.49
|
-0.3 diopter
Standard Deviation 0.49
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 3 from second eye implantationPopulation: This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute.
Outcome measures
| Measure |
ReSTOR +3
n=13 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
|
Acri.LISA
n=13 Participants
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
|
Acri.LISA/Without
n=10 Participants
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
|
Acri.LISA/With
n=10 Participants
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
|
|---|---|---|---|---|
|
Mean Radner Reading Speed
|
90.60 wpm
Standard Deviation 26.82
|
90.46 wpm
Standard Deviation 22.19
|
109.7 wpm
Standard Deviation 18.21
|
113.2 wpm
Standard Deviation 17.80
|
SECONDARY outcome
Timeframe: Month 3 from second eye implantationPopulation: This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.
Outcome measures
| Measure |
ReSTOR +3
n=13 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
|
Acri.LISA
n=10 Participants
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
|
Acri.LISA/Without
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
|
Acri.LISA/With
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
|
|---|---|---|---|---|
|
Patient Reported Outcomes at Month 3
Near function scale score
|
1.78 units on a scale
Standard Deviation 0.76
|
1.48 units on a scale
Standard Deviation 0.84
|
—
|
—
|
|
Patient Reported Outcomes at Month 3
Intermediate function scale score
|
1.13 units on a scale
Standard Deviation 0.18
|
1.19 units on a scale
Standard Deviation 0.38
|
—
|
—
|
|
Patient Reported Outcomes at Month 3
Extended intermediate function scale score
|
1.32 units on a scale
Standard Deviation 0.51
|
1.00 units on a scale
Standard Deviation 0.00
|
—
|
—
|
|
Patient Reported Outcomes at Month 3
Distant function scale score
|
1.08 units on a scale
Standard Deviation 0.13
|
1.04 units on a scale
Standard Deviation 0.10
|
—
|
—
|
Adverse Events
ReSTOR +3
Acri.LISA
Serious adverse events
| Measure |
ReSTOR +3
n=17 participants at risk
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
|
Acri.LISA
n=13 participants at risk
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL
|
|---|---|---|
|
Eye disorders
Macular oedema
|
5.9%
1/17
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
0.00%
0/13
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
|
Eye disorders
Posterior capsule rupture
|
5.9%
1/17
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
0.00%
0/13
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
Other adverse events
| Measure |
ReSTOR +3
n=17 participants at risk
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
|
Acri.LISA
n=13 participants at risk
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL
|
|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
11.8%
2/17
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
0.00%
0/13
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
|
Eye disorders
Conjunctival hyperaemia
|
5.9%
1/17
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
0.00%
0/13
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
|
Eye disorders
Conjunctivitis
|
5.9%
1/17
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
0.00%
0/13
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
|
Eye disorders
Corneal oedema
|
29.4%
5/17
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
7.7%
1/13
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
|
Eye disorders
Corneal oedema/ocular hypertension
|
5.9%
1/17
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
0.00%
0/13
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
|
Eye disorders
Ocular hyperaemia/lacrimation
|
5.9%
1/17
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
0.00%
0/13
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
|
Eye disorders
Retinal cyst
|
5.9%
1/17
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
0.00%
0/13
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
|
Investigations
Intraocular pressure abnormal
|
5.9%
1/17
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
0.00%
0/13
This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
|
Additional Information
Brand Lead, Surgical, Global Medical Affairs
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