Patient Satisfaction Clinical Trial
Official title:
A 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: the Alcon CLAREON® and the Abbott Medical Optics PCB00 Lenses
NCT number | NCT03364972 |
Other study ID # | 232017 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 6, 2018 |
Est. completion date | August 1, 2019 |
Verified date | August 2019 |
Source | Guy's and St Thomas' NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 145 |
Est. completion date | August 1, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - bilateral cataracts - good visual potential - ability to understand informed consent and objectives of the trial - not-pregnant - not breast feeding - no previous eye surgery - corneal astigmatism less than 1 diopter in both eyes 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: - Significant corneal opacities - Small pupils following pharmacological dilatation - Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine |
Country | Name | City | State |
---|---|---|---|
United Kingdom | St Thomas' Hospital NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust | City, University of London, King's College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Contrast sensitivity | 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 | |
Other | 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 | |
Other | 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 | |
Primary | Visual acuity | As measured by conventional LogMAR visual acuity charts | 13 months | |
Secondary | Incidence of intraocular lens glistenings | Incidence of presence of intraocular lens glistenings in each study arm | 13 months | |
Secondary | Severity of intraocular lens glistenings | Number of vacuoles per square millimetre | 13 months | |
Secondary | 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 |
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