Clinical Evaluation of Toric Intraocular Lens Made by Aurolab (TORICIOL)
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| First Received Date ICMJE | July 14, 2011 | ||||||||
| Last Updated Date | January 7, 2013 | ||||||||
| Start Date ICMJE | August 2011 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
vision improvement [ Time Frame: 150 days ] [ Designated as safety issue: No ] The visual acuity will be measured after iol implantation on 1 day, 10 days, 40 days and 150 days post operatively |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01396616 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Refractive error correction [ Time Frame: 150 days ] [ Designated as safety issue: No ] To measure the refraction error after IOL implantation on 1 day, 10 days, 40 days and 150 days post operatively |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Clinical Evaluation of Toric Intraocular Lens Made by Aurolab | ||||||||
| Official Title ICMJE | Clinical Evaluation of Toric Intraocular Lens Made by Aurolab | ||||||||
| Brief Summary | The purpose of this study is to measure visual acuity and Intraocular Lens (IOL) rotational stability after implantation of TORIC IOL and to assess the post operative complications after implantation of TORIC IOL. |
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| Detailed Description | Among available methods for treating astigmatism in cataract surgery, the implantation of toric IOLs is an emerging technology that shows promising results. Similar to implanting a one-piece acrylic lens, toric IOLs provide good distance vision and, in many patients, freedom from spectacles for distance vision. A low absolute residual refractive cylinder has been associated with the implantation of toric IOLs, and the safety profile for toric IOLs has been good. As improvements with regard to rotational stability and treatment and cylinder power range are made, toric IOLs will emerge as an effective, safe treatment option for correcting astigmatism during cataract surgery. Further, to evidence on the safety and efficacy of TORIC IOL for patients having cataract associated with astigmatism served as the basis for us to identify the published literature on the safety and efficacy of TORIC IOL implantation in the treatment of cataract associated with astigmatism, thus provide a background for the development of clinical investigation plan for the present study. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Astigmatism | ||||||||
| Intervention ICMJE | Device: Experimental - Toric Intraocular lenses
Toric Intraocular Lenses will be implenated with cataract patients having astigmatism |
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| Study Arm (s) | Experimental: Single Arm
The enrolled subject will be implanted with Toric IOL manufactured by AuroLab
Intervention: Device: Experimental - Toric Intraocular lenses |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 40 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | India | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01396616 | ||||||||
| Other Study ID Numbers ICMJE | 1PN1011037 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Aurolab | ||||||||
| Study Sponsor ICMJE | Aurolab | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Aurolab | ||||||||
| Verification Date | July 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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