Cataract Extraction, Cataract Surgery, Glistenings, Hydrophobic Acrylic, Intraocular Lens Implant, Light Scatter, Patient Related Outcome Measures, Patient Satisfaction, Phacoemulsification
Conditions
Keywords
cataract, cataract extraction, interocular lens implant, glistenings, phacoemulsification, hydrophobic acrylic, light scatter, patient related outcome measures
Brief summary
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.
Interventions
DEVICECataract surgery
Conventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant
Sponsors
City, University of London
King's College London
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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 *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 13 months | As measured by conventional LogMAR visual acuity charts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraocular lens glistenings | 13 months | Incidence of presence of intraocular lens glistenings in each study arm |
| Severity of intraocular lens glistenings | 13 months | Number of vacuoles per square millimetre |
| Refraction (i.e. glasses prescription) | 13 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Forward light scatter | 13 months | 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. |
| Contrast sensitivity | 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. |
| Patient satisfaction | 13 months | Validated patient satisfaction questionnaire. We use specially designed and validated conversion tables to convert raw scores from questionnaires to Rasch calibrated measures. |
| Self-reported health | 13 months | 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). |
Countries
United Kingdom
Outcome results
None listed