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Clinical Investigation of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01424189
First received: August 25, 2011
Last updated: January 13, 2017
Last verified: January 2017
Results First Received: January 13, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cataracts
Interventions: Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Device: AcrySof® ReSTOR® Multifocal IOL Model SA60D3

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 21 investigative sites located in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 677 participants enrolled, 103 were exited prior to randomization as screen failures. This reporting population includes all participants with successful IOL implantation in at least 1 eye (574).

Reporting Groups
  Description
ReSTOR Toric IOL AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
ReSTOR IOL AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation

Participant Flow:   Overall Study
    ReSTOR Toric IOL   ReSTOR IOL
STARTED   386   188 
COMPLETED   373   182 
NOT COMPLETED   13   6 
Adverse Event                1                0 
Lost to Follow-up                4                1 
Withdrawal by Subject                4                4 
Subject moved                1                0 
Death                3                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
This analysis population includes all participants with successful IOL implantation in at least 1 eye.

Reporting Groups
  Description
ReSTOR Toric IOL AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
ReSTOR IOL AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation
Total Total of all reporting groups

Baseline Measures
   ReSTOR Toric IOL   ReSTOR IOL   Total 
Overall Participants Analyzed 
[Units: Participants]
 386   188   574 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.91  (9.20)   68.36  (8.13)   67.38  (8.88) 
Gender 
[Units: Participants]
Count of Participants
     
Female      240  62.2%      136  72.3%      376  65.5% 
Male      146  37.8%      52  27.7%      198  34.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5   [ Time Frame: Month 12 from second eye implantation ]

2.  Primary:   Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5   [ Time Frame: Month 12 from second eye implantation ]

3.  Primary:   Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5   [ Time Frame: Month 12 from second eye implantation ]

4.  Secondary:   Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5   [ Time Frame: Month 12 from second eye implantation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Expert Clinical Project Lead, GCRA, Surgical
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com



Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01424189     History of Changes
Other Study ID Numbers: C-09-036
Study First Received: August 25, 2011
Results First Received: January 13, 2017
Last Updated: January 13, 2017