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

This study has been completed.
Sponsor:
Information provided by:
Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT01121861
First received: May 10, 2010
Last updated: May 11, 2010
Last verified: May 2010
  Purpose

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 Intervention
Astigamtism
Procedure: Phacoemulsification with implantation of toric IOL

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Singapore National Eye Centre:

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

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

Estimated Enrollment: 100
Study Start Date: June 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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