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Comparison of Functional Vision Provided by AMO Tecnis Z9000 and Alcon SA60AT Acrysof

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00459303
First received: April 10, 2007
Last updated: December 29, 2013
Last verified: December 2013
Results First Received: October 5, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cataract
Interventions: Device: aspherical intraocular lens
Device: spherical intraocular lens

  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
Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye. All cases were enrolled from October 2005 to April 2006 and were followed up for at least three months at the department of ophthalmology.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with diabetes or other systemic disease, such as dysthyroid related orbitopathy or drug related optic neuropathy, that may potentially affect contrast sensitivity and visual quality were excluded.

Reporting Groups
  Description
Cataract Patients Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye.

Participant Flow:   Overall Study
    Cataract Patients  
STARTED     20  
COMPLETED     20  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
Cataract Patients Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye

Baseline Measures
    Cataract Patients  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     15  
Age  
[units: years]
Mean ± Standard Deviation
  70.4  ± 9.34  
Gender  
[units: participants]
 
Female     11  
Male     9  
Region of Enrollment  
[units: participants]
 
Taiwan     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition   [ Time Frame: average data of post-op 3rd, 6th, 12th week measurements ]

2.  Primary:   Best Corrected Contrast Sensitivity in Photopic Condition   [ Time Frame: average data of post-operative 3rd week, 6th week, 12th week measurements ]

3.  Secondary:   Corneal High-order Aberrations   [ Time Frame: pre-op & averate data of post-op 3rd, 6th, 12th week measurements ]

4.  Secondary:   Total Ocular High-order Aberrations   [ Time Frame: average data of post-op 3rd, 6th, 12th week measurements ]


  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
small sample size


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Fung-Rong Hu
Organization: National Taiwan University Hospital
phone: +886223123456 ext 2131
e-mail: fungronghu@ntuh.gov.tw


No publications provided


Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00459303     History of Changes
Other Study ID Numbers: 05012006
Study First Received: April 10, 2007
Results First Received: October 5, 2009
Last Updated: December 29, 2013
Health Authority: Taiwan: Department of Health