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A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)

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ClinicalTrials.gov Identifier: NCT01257217
Recruitment Status : Completed
First Posted : December 9, 2010
Results First Posted : April 20, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Cataract
Interventions Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT
Device: Acri.LISA® 366D IOL
Device: Acri.LISA® 466TD Toric IOL
Enrollment 31
Recruitment Details Subjects were recruited from one investigative site located in Spain.
Pre-assignment Details Of the 31 enrolled participants, 1 exited prior to randomization due to withdrawn consent and 5 discontinued after randomization due to adverse event (1) and protocol deviation (4).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).
Arm/Group Title ReSTOR +3 Acri.LISA
Hide Arm/Group Description 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® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
Period Title: Overall Study
Started 15 10
Completed 13 10
Not Completed 2 0
Arm/Group Title ReSTOR +3 Acri.LISA Total
Hide Arm/Group Description 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® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation Total of all reporting groups
Overall Number of Baseline Participants 15 10 25
Hide Baseline Analysis Population Description
This analysis population includes all randomized participants who received IOLs without major deviations and/or surgical complications (efficacy population).
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 10 participants 25 participants
< 21 years 0 0 0
≥ 21 years 15 10 25
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 10 participants 25 participants
Female
9
  60.0%
8
  80.0%
17
  68.0%
Male
6
  40.0%
2
  20.0%
8
  32.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 15 participants 10 participants 25 participants
15 10 25
1.Primary Outcome
Title Mean Binocular Defocus VA at Month 3
Hide Description 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.
Time Frame Month 3 from second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
Arm/Group Title ReSTOR +3 Acri.LISA
Hide Arm/Group Description:
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® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
Overall Number of Participants Analyzed 13 10
Mean (Standard Deviation)
Unit of Measure: logMAR
-5.00 diopter 0.78  (0.26) 0.59  (0.18)
-4.50 diopter 0.65  (0.18) 0.45  (0.17)
-4.00 diopter 0.58  (0.19) 0.29  (0.13)
-3.50 diopter 0.36  (0.13) 0.18  (0.14)
-3.00 diopter 0.15  (0.07) 0.11  (0.21)
-2.50 diopter 0.04  (0.08) 0.08  (0.20)
-2.00 diopter 0.14  (0.13) 0.20  (0.18)
-1.50 diopter 0.30  (0.11) 0.33  (0.18)
-1.00 diopter 0.23  (0.10) 0.22  (0.16)
-0.50 diopter 0.07  (0.06) 0.07  (0.11)
0.00 diopter -0.02  (0.07) -0.05  (0.14)
+0.50 diopter 0.06  (0.08) 0.06  (0.18)
+1.00 diopter 0.26  (0.11) 0.21  (0.16)
+1.50 diopter 0.54  (0.21) 0.37  (0.19)
+2.00 diopter 0.63  (0.23) 0.51  (0.16)
2.Secondary Outcome
Title Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3
Hide Description 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.
Time Frame Month 3 from second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
Arm/Group Title ReSTOR +3 Acri.LISA
Hide Arm/Group Description:
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® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
Overall Number of Participants Analyzed 13 10
Mean (Standard Deviation)
Unit of Measure: logMAR
Far distance 4 meters (m) -0.02  (0.08) -0.05  (0.15)
Intermediate 70 centimeters (cm) 0.39  (0.11) 0.35  (0.09)
Intermediate 60 cm 0.33  (0.10) 0.35  (0.09)
Intermediate 50 cm 0.24  (0.11) 0.28  (0.11)
Near 33/40 cm 0.19  (0.13) 0.20  (0.15)
3.Secondary Outcome
Title Uncorrected Visual Acuity Across a Range of Distances at Month 3
Hide Description 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.
Time Frame Month 3 from second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
Arm/Group Title ReSTOR +3 Acri.LISA
Hide Arm/Group Description:
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® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
Overall Number of Participants Analyzed 13 10
Mean (Standard Deviation)
Unit of Measure: logMAR
Far distance 4 meters (m) 0.14  (0.20) 0.03  (0.16)
Intermediate 70 centimeters (cm) 0.37  (0.15) 0.27  (0.14)
Intermediate 60 cm 0.36  (0.16) 0.33  (0.12)
Intermediate 50 cm 0.29  (0.19) 0.33  (0.12)
Near 33/40 cm 0.27  (0.18) 0.28  (0.12)
4.Secondary Outcome
Title Mean Refractive Spherical Equivalent at Month 3
Hide Description 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.
Time Frame Month 3 from second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
Arm/Group Title ReSTOR +3 Acri.LISA
Hide Arm/Group Description:
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® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
Overall Number of Participants Analyzed 13 10
Mean (Standard Deviation)
Unit of Measure: diopter
0.1  (0.49) -0.3  (0.49)
5.Secondary Outcome
Title Mean Radner Reading Speed
Hide Description 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.
Time Frame Month 3 from second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
Arm/Group Title ReSTOR +3/Without ReSTOR +3/With Acri.LISA/Without Acri.LISA/With
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
Overall Number of Participants Analyzed 13 13 10 10
Mean (Standard Deviation)
Unit of Measure: wpm
90.60  (26.82) 90.46  (22.19) 109.7  (18.21) 113.2  (17.80)
6.Secondary Outcome
Title Patient Reported Outcomes at Month 3
Hide Description 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.
Time Frame Month 3 from second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.
Arm/Group Title ReSTOR +3 Acri.LISA
Hide Arm/Group Description:
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® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
Overall Number of Participants Analyzed 13 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Near function scale score Number Analyzed 13 participants 10 participants
1.78  (0.76) 1.48  (0.84)
Intermediate function scale score Number Analyzed 2 participants 4 participants
1.13  (0.18) 1.19  (0.38)
Extended intermediate function scale score Number Analyzed 13 participants 9 participants
1.32  (0.51) 1.00  (0.00)
Distant function scale score Number Analyzed 6 participants 6 participants
1.08  (0.13) 1.04  (0.10)
Time Frame [Not Specified]
Adverse Event Reporting Description This analysis group includes all subjects who were randomized (N=17 for ReSTOR+3, N=13 for Acri.LISA) into the study.
 
Arm/Group Title ReSTOR +3 Acri.LISA
Hide Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL
All-Cause Mortality
ReSTOR +3 Acri.LISA
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ReSTOR +3 Acri.LISA
Affected / at Risk (%) Affected / at Risk (%)
Total   2/17 (11.76%)   0/13 (0.00%) 
Eye disorders     
Macular oedema  1  1/17 (5.88%)  0/13 (0.00%) 
Posterior capsule rupture  1  1/17 (5.88%)  0/13 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ReSTOR +3 Acri.LISA
Affected / at Risk (%) Affected / at Risk (%)
Total   10/17 (58.82%)   1/13 (7.69%) 
Eye disorders     
Conjunctival haemorrhage  1  2/17 (11.76%)  0/13 (0.00%) 
Conjunctival hyperaemia  1  1/17 (5.88%)  0/13 (0.00%) 
Conjunctivitis  1  1/17 (5.88%)  0/13 (0.00%) 
Corneal oedema  1  5/17 (29.41%)  1/13 (7.69%) 
Corneal oedema/ocular hypertension  1  1/17 (5.88%)  0/13 (0.00%) 
Ocular hyperaemia/lacrimation  1  1/17 (5.88%)  0/13 (0.00%) 
Retinal cyst  1  1/17 (5.88%)  0/13 (0.00%) 
Investigations     
Intraocular pressure abnormal  1  1/17 (5.88%)  0/13 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title: Brand Lead, Surgical, Global Medical Affairs
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01257217     History of Changes
Other Study ID Numbers: M09-051
First Submitted: December 8, 2010
First Posted: December 9, 2010
Results First Submitted: January 13, 2017
Results First Posted: April 20, 2017
Last Update Posted: July 2, 2018