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| Name | Class |
|---|---|
| City, University of London | OTHER |
| King's College London | OTHER |
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This is a bilateral randomised controlled study to compare visual performance, refractive outcome, forward light scatter, patient satisfaction and objective measurement of glistenings following insertion of two monofocal, aspheric, hydrophobic acrylic intraocular lenses (IOLs). A new product is compared with an established one.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental intraocular lens implant | Experimental | 'Alcon Clareon' : New monofocal, hydrophobic acrylic intraocular lens implant |
|
| Standard intraocular lens implant | Active Comparator | Abbott Tecnis PCB00- Standard monofocal,hydrophobic acrylic intraocular lens implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cataract surgery | Device | Conventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | As measured by conventional LogMAR visual acuity charts | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraocular lens glistenings | Incidence of presence of intraocular lens glistenings in each study arm | 13 months |
| Severity of intraocular lens glistenings | Number of vacuoles per square millimetre |
| Measure | Description | Time Frame |
|---|---|---|
| Forward light scatter | Intraocular (forward) light scatter is measured with a specifically devised computerised vision test. It is represented by straylight parameter, Log(s), on a logarithmic scale from 0 to 1.5. The lower the value (i.e. closer to 0), the better the outcome. | 13 months |
| Contrast sensitivity |
Inclusion Criteria:
Exclusion Criteria:
age-related macula degeneration
glaucoma
previous retinal vascular disorders
previous retinal detachment or tear
any neuro-ophthalmological condition
any inherited retinal disorder or pathology
previous strabismus surgery or record of amblyopia
previous transient ischaemic attacks, cerebrovascular events or other vaso-occlusive disease
already enrolled in another study
Exclusion criteria relate to clinical contraindications for Femtosecond Laser Assisted Cataract Surgery, such as:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Thomas' Hospital NHS Trust | London | SE1 7EH | United Kingdom |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 27, 2020 | |
| Reset | Jun 11, 2020 |
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| 13 months |
| Refraction (i.e. glasses prescription) | In conventional sphere/cylinder dioptre scales: total range -40 to +40, in 0.25 steps. Higher values represent worse outcome. Values closer to 0 (zero) represent better outcome | 13 months |
Visual acuity (LogMAR scale: total range -0.2 to 1.0 in 0.02 steps) measured at different contrasts with a computerized contrast sensitivity chart. Negative values, or values closer to 0, represent better outcome. |
| 13 months |
| Patient satisfaction | Validated patient satisfaction questionnaire. We use specially designed and validated conversion tables to convert raw scores from questionnaires to Rasch calibrated measures. | 13 months |
| Self-reported health | Validated self-reported health questionnaire. We use a vertical Visual Analogue Scale (VAS) to record patients' self-reported health on a scale from 0-100 (values closer or equal to 100 represent better outcome). | 13 months |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 27, 2020 | Jun 11, 2020 |
| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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