Assessment of Visual Function and Optics in Intraocular Lenses
Tracking Information | |||||
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First Received Date ICMJE | July 17, 2012 | ||||
Last Updated Date | July 30, 2012 | ||||
Start Date ICMJE | September 2012 | ||||
Estimated Primary Completion Date | October 2015 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Unaided distance and near vision [ Time Frame: Measured at 3-6 months after surgery ] [ Designated as safety issue: No ] Visual Acuity (logMAR) |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01654159 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Assessment of Visual Function and Optics in Intraocular Lenses | ||||
Official Title ICMJE | Evaluating Subjective and Objective Performance of Instrumentation Used and Devices Implanted in Cataract Surgery | ||||
Brief Summary | The main objective of this research is to assess visual function and optical performance of CE marked, implanted intraocular lenses to understand the individual factors that affect their performance and how these may be improved in future designs and to evaluate measurement techniques. All outcome measures will be captured 3-6 months after surgery |
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Detailed Description | A cataract occurs when the natural lens of the eye, which plays a major role in the focusing of light and production of sharp visual images, becomes cloudy and hardens, resulting in a loss of visual function. Left untreated, cataracts can cause preventable blindness. During cataract surgery the natural lens is removed and a man-made intraocular lens (IOL) is implanted in its place. IOL technology has advanced significantly in recent years and as a result the main goal of cataract surgery is no longer simply the successful removal of the cloudy lens and restoration of vision. Providing patients with the best possible refractive outcome and the best possible visual quality is now much more important when assessing surgery outcomes. Aspheric, multifocal and accommodating IOLs are among the new designs developed to improve visual outcome after cataract surgery. In order to assess the effectiveness of these designs, visual function needs to be evaluated both objectively and subjectively following their implantation. Such evaluation allows the continued evolution of these IOL designs towards optimum. This proposed research study, which aims to assess the visual function and optical performance of new CE marked IOLs after implantation, could significantly contribute to the enhancement and development of improved IOL designs in the future. We have successfully conducted similar patient trials for the past 5 years. As new IOL designs are constantly being developed, approved and CE marked, this type of research study will always have the potential to offer new information that is not currently available and has not previously been assessed or published and could contribute towards improved IOL designs in the future. All outcome measures will be captured 3-6 months after surgery |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Cataract | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* 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 | Not yet recruiting | ||||
Estimated Enrollment ICMJE | 500 | ||||
Estimated Completion Date | October 2015 | ||||
Estimated Primary Completion Date | October 2015 (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 85 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01654159 | ||||
Other Study ID Numbers ICMJE | IOL2012 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Aston University | ||||
Study Sponsor ICMJE | Aston University | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Aston University | ||||
Verification Date | July 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |