Symptomatic age-related cataract Eye Diseases Senile cataract
Conditions
Interventions
Arm A: manual phacoemulsification cataract surgery in the study eye
Arm B: laser-assisted phacoemulsification cataract surgery in the study eye
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 or over with symptomatic age-related cataract, one or both eyes 2. Patients must be sufficiently fluent in English to provide informed consent and completion of the patient-reported outcome measures 3. Patients must be willing to attend for follow up at 3 and 12 months after first eye cataract surgery
Exclusion criteria
Exclusion criteria: 1. Secondary causes of cataract 2. Previous cataract, corneal or glaucoma surgery 3. Patient unable to give consent or unable to attend follow-up assessment 4. Patient unable to be positioned for surgery 5. Patient scheduled to undergo combined surgery, e.g. cataract and trabeculectomy 6. Previously identified poor pupil dilation 7. Post-operative intended refractive target is not between (+0.50 and -0.50 dioptres) for the study eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unaided distance visual acuity (UDVA, logMAR) at 3 months following surgery in the study eye measured using a standard ETDRS chart at a distance of 4 metres | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Unaided distance visual acuity (UDVA) in the study eye at 12 months after surgery 2. Corrected distance visual acuity (logMAR) at 3 and 12 months after surgery in the study eye (ETDRS logMAR chart at 4 metres) 3. Ocular complications within 3 and 12 months of surgery in the study eye (and second eye). A complication will be defined as any event that causes unintentional injury to an ocular structure, or requires additional treatment, or has a negative effect on a patient's health or eyesight 4. Unaided and corrected visual distance acuity and complications in the second eye (for those with bilateral cataracts), and with both eyes open at 3 and 12 months after surgery 5. Percentage of patients within 0.5 and within 1 dioptre of intended refractive outcome 6. Patient-reported outcomes measures: vision health status using Rasch validated patient-reported outcome measures at 3 and 12 months: (Catquest-9SF) 7. Cost-utility analysis: within-trial cost-effectiveness analyses at 3 and 12 months and expected cost- effectiveness over patient lifetime. The analysis will conform to accepted economic evaluation methods and will use the EQ-5D-3L+vision bolt-on question (EQ-5DV) 8. Corneal endothelial cell count change (additional safety measure) at 3 and 12 months | — |
Countries
United Kingdom
Contacts
Public ContactVicky McCudden
Outcome results
None listed