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Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

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ClinicalTrials.gov Identifier: NCT01200511
Recruitment Status : Completed
First Posted : September 13, 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 Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cataract
Intervention Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Enrollment 49
Recruitment Details Subjects were recruited from 5 investigational sites located in Germany (2), Venezuela (2), and Spain (1).
Pre-assignment Details This reporting population includes all enrolled subjects.
Arm/Group Title ReSTOR +3.0 Toric
Hide Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Period Title: Overall Study
Started 49
Completed 44
Not Completed 5
Reason Not Completed
Lost to Follow-up             3
Withdrawal by Subject             1
Adverse Event             1
Arm/Group Title ReSTOR +3.0 Toric
Hide Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
This analysis population includes all patients receiving IOL implantation in both eyes that completed the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
62.52  (7.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
30
  68.2%
Male
14
  31.8%
1.Primary Outcome
Title Uncorrected Visual Acuity Across a Range of Distances at Month 6
Hide Description Visual acuity (VA) was tested binocularly (both eyes together) 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 6 from second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.
Arm/Group Title ReSTOR +3.0 Toric
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Overall Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: logMAR
Far distance 4 meters (m) 0.05  (0.10)
Intermediate 70 centimeters (cm) 0.15  (0.13)
Intermediate 60 cm 0.09  (0.11)
Intermediate 50 cm 0.05  (0.09)
Near 40 cm 0.07  (0.09)
Near - preferred 0.04  (0.08)
2.Primary Outcome
Title Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6
Hide Description VA was tested binocularly 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 6 from second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.
Arm/Group Title ReSTOR +3.0 Toric
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Overall Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: logMAR
Far distance 4 m 0.00  (0.06)
Intermediate 70 cm 0.19  (0.14)
Intermediate 60 cm 0.14  (0.14)
Intermediate 50 cm 0.06  (0.10)
Near 40 cm 0.04  (0.07)
Near - preferred distance 0.05  (0.08)
3.Primary Outcome
Title Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6
Hide Description Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.
Time Frame Month 6 from second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.
Arm/Group Title ReSTOR +3.0 Toric
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of participants
± 0.5D 84.5
± 0.75D 92.9
±1.0D 95.2
4.Secondary Outcome
Title Patient Reported Outcomes at Month 6
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. Distance specific tasks were rated (without / with corrective aids) 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 6 from second eye implantation
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit. A subject may have responded with and without.
Arm/Group Title ReSTOR +3.0 Toric/Without ReSTOR +3.0 Toric/With
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids if needed
Overall Number of Participants Analyzed 44 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Near function scale score Number Analyzed 39 participants 5 participants
1.72  (0.65) 1.65  (0.60)
Intermediate function scale score Number Analyzed 39 participants 6 participants
1.49  (0.59) 1.21  (0.51)
Extended intermediate function scale score Number Analyzed 39 participants 7 participants
1.24  (0.38) 1.20  (0.37)
Time Frame An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user, or other persons regardless of causal relationship.
Adverse Event Reporting Description This analysis population includes all enrolled subjects that underwent surgery independent of IOL implantation.
 
Arm/Group Title ReSTOR +3.0 Toric
Hide Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
All-Cause Mortality
ReSTOR +3.0 Toric
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ReSTOR +3.0 Toric
Affected / at Risk (%)
Total   7/49 (14.29%) 
Eye disorders   
Macular oedema  1  1/49 (2.04%) 
Gastrointestinal disorders   
Gastrointestinal bleeding  1  1/49 (2.04%) 
General disorders   
Device dislocation  1  3/49 (6.12%) 
Investigations   
Intraocular pressure test abnormal  1  1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/49 (2.04%) 
Surgical and medical procedures   
Intraocular Lens Repositioning  1  3/49 (6.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ReSTOR +3.0 Toric
Affected / at Risk (%)
Total   3/49 (6.12%) 
Eye disorders   
Posterior capsule opacification  1  3/49 (6.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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: NCT01200511     History of Changes
Other Study ID Numbers: M09-052
First Submitted: September 10, 2010
First Posted: September 13, 2010
Results First Submitted: January 13, 2017
Results First Posted: April 20, 2017
Last Update Posted: July 2, 2018