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Prospective Comparative Study of Refractive Outcome of STAAR and Alcon Toric Intraocular Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01121861
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : May 12, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
Several methods have been developed to address and reduce preexisting astigmatism. The refractive results associated with the use of toric IOLs are likely to be more predictable. Other advantages of toric IOL include absence of need for any additional astigmatic correction procedure during cataract surgery, faster visual recovery as well as the reversibility of the procedure. There has not been any trial carried out to evaluate the results of toric IOL in either the investigators local population or in East Asia. Hence, the investigators set out to evaluate and compare the efficacy, safety, predictability and stability of the STAAR and Alcon toric IOL in Asian eyes.

Condition or disease Intervention/treatment
Astigamtism Procedure: Phacoemulsification with implantation of toric IOL

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Prospective Comparative Study of the Efficacy, Predictability, Safety and Stability of the STAAR and Alcon Toric Intraocular Lenses Implanted in Asian Eyes During Phacoemulsification Surgery
Study Start Date : June 2007
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Amount of astigmatism reduction [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Stability of toric IOL [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Suitability for phacoemulsification surgery.
  2. Regular corneal astigmatism of at least 1.25D and not exceeding 2.0D.
  3. Age range between 21-80 years.
  4. Informed consent of surgery and implantation of toric IOL obtained.

Exclusion Criteria:

  1. Presence of irregular corneal astigmatism.
  2. Regular corneal astigmatism less than 1.0D.
  3. Presence of other ocular diseases that may compromise on the visual outcome such as glaucoma, retinal diseases, macular diseases and corneal diseases.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121861


Locations
Singapore
Singapore National Eye Centre
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
Principal Investigator: Wei Han Chua, FRCS, FAMS Singapore National Eye Centre
Principal Investigator: Jocelyn Chua, MRCS, MMED Singapore National Eye Centre