Prospective Comparative Study of Refractive Outcome of STAAR and Alcon Toric Intraocular Lenses
This study has been completed.
Sponsor:
Singapore National Eye Centre
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
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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:
- Suitability for phacoemulsification surgery.
- Regular corneal astigmatism of at least 1.25D and not exceeding 2.0D.
- Age range between 21-80 years.
- Informed consent of surgery and implantation of toric IOL obtained.
Exclusion Criteria:
- Presence of irregular corneal astigmatism.
- Regular corneal astigmatism less than 1.0D.
- 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
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 |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT01121861 History of Changes |
| Other Study ID Numbers: | R536/24/2007 |
| Study First Received: | May 10, 2010 |
| Last Updated: | May 11, 2010 |
| Health Authority: | Singapore: Clinical Trials & Epidemiology Research Unit (CTERU) |
Keywords provided by Singapore National Eye Centre:
|
efficacy safety predictability stability |
toric IOL refractive astigmatism phacoemulsification |
ClinicalTrials.gov processed this record on May 23, 2013