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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monofocal | Placebo Comparator | Monofocal IOL Implant Manufacturers of IOLs used as monofocal comparator are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss |
|
| Multifocal | Experimental | Multifocal IOL Manufacturers of multifocal IOLs under investigation are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss |
|
| Toric | Experimental | Toric IOL Manufacturers of toric IOLs under investigation are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monofocal IOL | Procedure | Monofocal Intraocular lens will be implanted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unaided distance and near vision | Visual Acuity (logMAR) | Measured at 3-6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | NAVQ score | Measured at 3-6 months after surgery |
| Residual refraction | Autorefraction / subjective refraction | Measured at 3-6 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunil Shah, FRCS | Birmingham Midland Eye Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Midland Eye Centre | Birmingham | West Midlands | B18 7QH | United Kingdom |
Data collaboration will be considered on request
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000075542 | Multifocal Intraocular Lenses |
| ID | Term |
|---|---|
| D007910 | Lenses, Intraocular |
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Multifocal IOL | Procedure | Multifocal IOL will be implanted |
|
| Toric IOL | Procedure | Toric IOLS will be implanted |
|
| Aberrations | Aberrometry | Measured at 3-6 months after surgery |
| Corrected distance and near acuity | Acuity (logMAR) | Measured at 3-6 months after surgery |
| D019736 |
| Prostheses and Implants |