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| Name | Class |
|---|---|
| BMI Southend Hospital | OTHER |
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During cataract surgery an artificial lens is implanted in the eye. These artificial lenses are called intraocular lenses (IOLs) and there are many different types of IOL designs. IOLs are of fixed focus and so unless a multifocal IOL is used you would need to wear spectacles for viewing near objects. This study has been designed to look at how well a multifocal IOL corrects distance and near vision in comparison with a conventional monofocal IOL. Both types of IOLs are commercially available and are commonly implanted. Using new non-invasive methods we hope to be able to better judge the visual performance of these IOLs. In addition the study will involve imaging and examining the IOLs to determine the prevalence of any post-operative complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bi flex M multifocal intraocular lens | Experimental | Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens |
|
| Bi flex 1.8 monofocal intraocular | Active Comparator | Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bi flex M multifocal intraocular lens | Device | Multifocal intraocular lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long Term Monocular Visual Acuity (VA) | Monocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR | Visit 2 [12-18 months] |
| Long Term Binocular Visual Acuity (VA) | Binocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR | Visit 2 [12-18 months] |
| Monocular Visual Acuity (VA) | Monocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR | Visit 1 [3-6 months] |
| Binocular Visual Acuity (VA) | Binocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR | Visit 1 [3-6 months] |
| Defocus Curve Profiles | Visual acuity measurement (assessed in LogMAR) taken with differing levels of optical defocus | visit 1 (3-6 months) |
| Long Term Defocus Curve Profiles | Assessed as a dioptric range and using the Defocus area metric | visit 2 (12-18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Long Term Monocular Pelli-Robson Contrast Sensitivity (CS) | MonocularContrast sensitivity assessed as a contrast threshold using the Pelli-Robson test | Visit 2 [12-18 months] |
| Long Term Binocular Pelli-Robson Contrast Sensitivity (CS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip J Buckhurst, PhD | Plymouth University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bi Flex M Multifocal Intraocular Lens | Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens |
| FG001 | Bi Flex 1.8 Monofocal Intraocular | Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bi Flex M Monofocal Intraocular Lens | Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens |
| BG001 | Bi Flex M Multifocal Intraocular Lens |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Long Term Monocular Visual Acuity (VA) | Monocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR | Posted | Mean | Standard Deviation | LogMAR | Visit 2 [12-18 months] |
|
Data collected for 18 months post surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bi Flex 1.8 Monofocal Intraocular | Subjects implanted bilaterally with the Bi flex 1.8 monofocal intraocular lens Bi flex 1.8 monofocal intraocular lens: Standard monofocal intraocular lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Phillip Buckhurst | University of Plymouth | 01752 588884 | phillip.buckhurst@plymouth.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2015 | Jun 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Bi flex 1.8 monofocal intraocular lens | Device | Standard monofocal intraocular lens |
|
Binocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test
| Visit 2 [12-18 month] |
| Pelli-Robson Monocular Contrast Sensitivity | Monocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test | Visit 1 [3-6 months] |
| Pelli-Robson Binocular Contrast Sensitivity | Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test | Visit 1 [3-6 months] |
| Long Term Contrast Sensitivity CSV-1000 | Binocular Assessment of Contrast Sensitivity at threshold using the Contrast sensitivity vision(CSV) CSV-1000 | Visit 2 [12-18 months] |
| Contrast Sensitivity CSV-1000 | Binocular Assessment of Contrast Sensitivity at threshold using the CSV-1000 | Visit 1 [3-6 months] |
| Long Term Reading Performance | Assessed as the critical print size and using the reading performance index. Uses Radner reading chart and logarithmic Radner scale (LogRAD) Lower LogRAD equals smaller print size | Visit 2 (12-18 months) |
| Reading Performance | Assessed as the critical print size and using the reading performance index Logarithmic Radner scale (LogRAD) Lower LogRAD equals small print size | visit 1 (3-6 months) |
| Long Term Glare | Assessed as the glare area size Scale 0 to 100 Higher scores = larger glare area =worse outcome | Visit 2 (12-18 months) |
| Glare | Assessed as the glare area size Scale 0 to 100 Higher score = larger area = worse outcome | visit 1 (3-6 months) |
Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pupil Size | Mean | Standard Deviation | Millimeters |
|
| Mean Spherical Equivalent | Manifest refraction performed at distance. Values are for the mean spherical equivalent (MSE) measured in dioptres MSE=sph+(cyl/2) Note no changes are necessary | Mean | Standard Deviation | Dioptres |
|
| J0 | Cylindrical correction defined in vector format. J0 describes astigmatic power along the horizontal meridian | Mean | Standard Deviation | Dioptres |
|
| J45 | Cylindrical correction defined in vector format. J45 describes astigmatic power along the vertical meridian | Mean | Standard Deviation | Dioptres |
|
| Pre-operative corrected distance visual acuity | Pre-operative best distance corrected visual acuity measured in LogMAR | Mean | Standard Deviation | LogMAR |
|
|
|
| Primary | Long Term Binocular Visual Acuity (VA) | Binocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR | Posted | Mean | Standard Deviation | LogMAR | Visit 2 [12-18 months] |
|
|
|
| Primary | Monocular Visual Acuity (VA) | Monocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR | Posted | Mean | Standard Deviation | LogMAR | Visit 1 [3-6 months] |
|
|
|
| Primary | Binocular Visual Acuity (VA) | Binocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR | Posted | Mean | Standard Deviation | LogMAR | Visit 1 [3-6 months] |
|
|
|
| Primary | Defocus Curve Profiles | Visual acuity measurement (assessed in LogMAR) taken with differing levels of optical defocus | Posted | Mean | Standard Deviation | LogMAR | visit 1 (3-6 months) |
|
|
|
| Primary | Long Term Defocus Curve Profiles | Assessed as a dioptric range and using the Defocus area metric | Posted | Mean | Standard Deviation | LogMAR | visit 2 (12-18 months) |
|
|
|
| Secondary | Long Term Monocular Pelli-Robson Contrast Sensitivity (CS) | MonocularContrast sensitivity assessed as a contrast threshold using the Pelli-Robson test | Posted | Mean | Standard Deviation | Log CS | Visit 2 [12-18 months] |
|
|
|
| Secondary | Long Term Binocular Pelli-Robson Contrast Sensitivity (CS) | Binocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test | Posted | Mean | Standard Deviation | Log CS | Visit 2 [12-18 month] |
|
|
|
| Secondary | Pelli-Robson Monocular Contrast Sensitivity | Monocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test | Posted | Mean | Standard Deviation | Log CS | Visit 1 [3-6 months] |
|
|
|
| Secondary | Pelli-Robson Binocular Contrast Sensitivity | Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test | Posted | Mean | Standard Deviation | Log CS | Visit 1 [3-6 months] |
|
|
|
| Secondary | Long Term Contrast Sensitivity CSV-1000 | Binocular Assessment of Contrast Sensitivity at threshold using the Contrast sensitivity vision(CSV) CSV-1000 | Posted | Mean | Standard Deviation | Log CS | Visit 2 [12-18 months] |
|
|
|
| Secondary | Contrast Sensitivity CSV-1000 | Binocular Assessment of Contrast Sensitivity at threshold using the CSV-1000 | Posted | Mean | Standard Deviation | Log CS | Visit 1 [3-6 months] |
|
|
|
| Secondary | Long Term Reading Performance | Assessed as the critical print size and using the reading performance index. Uses Radner reading chart and logarithmic Radner scale (LogRAD) Lower LogRAD equals smaller print size | Posted | Mean | Standard Deviation | LogRAD | Visit 2 (12-18 months) |
|
|
|
| Secondary | Reading Performance | Assessed as the critical print size and using the reading performance index Logarithmic Radner scale (LogRAD) Lower LogRAD equals small print size | Posted | Mean | Standard Deviation | LogRAD | visit 1 (3-6 months) |
|
|
|
| Secondary | Long Term Glare | Assessed as the glare area size Scale 0 to 100 Higher scores = larger glare area =worse outcome | Posted | Mean | Standard Deviation | units on a scale | Visit 2 (12-18 months) |
|
|
|
| Secondary | Glare | Assessed as the glare area size Scale 0 to 100 Higher score = larger area = worse outcome | Scale 0 to 100 Higher score = larger glare area = worse outcome | Posted | Mean | Standard Deviation | units on a scale | visit 1 (3-6 months) |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Bi Flex M Multifocal Intraocular Lens | Subjects implanted bilaterally with the Bi flex M multifocal intraocular lens Bi flex M multifocal intraocular lens: Multifocal intraocular lens | 1 | 50 | 0 | 50 | 0 | 50 |
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| Binocular Corrected Distance VA |
|
| Binocular Distance Corrected Intermediate VA |
|
| Binocular Distance Corrected Near VA |
|
| Monocular Corrected Distance VA |
|
| Monocular Distance Corrected Intermediate VA |
|
| Monocular Distance Corrected Near VA |
|
| Binocular Corrected Distance VA |
|
| Binocular Distance Corrected Intermediate VA |
|
| Binocular Distance Corrected Near VA |
|
| +0.50 |
|
| 0.00 |
|
| -0.50 |
|
| -1.00 |
|
| -1.50 |
|
| -2.00 |
|
| -2.50 |
|
| -3.00 |
|
| -3.50 |
|
| -4.00 |
|
| -4.50 |
|
| -5.00 |
|
| 0.50 |
|
| 0.00 |
|
| -0.50 |
|
| -1.00 |
|
| -1.50 |
|
| -2.00 |
|
| -2.50 |
|
| -3.00 |
|
| -3.50 |
|
| -4.00 |
|
| -4.50 |
|
| -5.00 |
|
| 12cpd |
|
| 18cpd |
|
| 12cpd |
|
| 18cpd |
|