Schedule for data collection and visits
| Normal | Baseline | Allocation | Treatment | Follow-up | |||||
|---|---|---|---|---|---|---|---|---|---|
| Prior to enrolment | Prior to surgery | Surgery | Standard non-study postoperative visit | 6 weeks (by post) | Visit 1: 3 months | 6 months (by post) | Visit 2: 12 months | ||
| Medical and ocular history | ✓ | ✓ | |||||||
| Consent for cataract surgery | ✓ | ||||||||
| Informed consent and eligibility screening | ✓ | ||||||||
| Identification of study eye | ✓ | ||||||||
| Visual acuity: UDVA, pinhole, +/− glasses (Snellen) | ✓ | ✓* | ✓ | ||||||
| Visual acuity (logMAR) with usual method of correction | ✓ | ||||||||
| Visual acuity: UDVA† and CDVA‡ (logMAR) each eye and binocular | ✓ | ✓ | |||||||
| Subjective refraction | ✓ | ✓ | |||||||
| Ocular biometry | ✓ | ||||||||
| Pentacam corneal topography | ✓§ | ✓ | ✓ | ✓ | |||||
| Optical coherence tomography (OCT) | ✓§ | ✓ | ✓§ | ✓ | ✓ | ||||
| Inclusion/exclusion criteria | ✓ | ✓ | |||||||
| Catquest-9SF questionnaire | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| EQ-5D-3L+vision bolt-on question (EQ-5DV) | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
| CSRI** | ✓ | ✓ | ✓ | ✓ | |||||
| Endothelial cell count measurement | ✓§ | ✓ | ✓ | ✓ | |||||
| Randomisation | ✓ | ||||||||
| Treatment: standard care: Manual Phacoemulsification Cataract Surgery | ✓ | ||||||||
| Treatment: Intervention: Femtosecond Laser-Assisted Phacoemulsification Cataract Surgery | ✓ | ||||||||
| Adverse event collection | ✓ | ✓†† | ✓ | ✓†† | ✓ | ||||
*Current glasses or unaided.
†UDVA: uncorrected distance visual acuity. All visual acuity measures will use the standard ETDRS logMAR chart at 4 metres.
‡CDVA: corrected distance visual acuity using subjective refraction result.
§Some patients will have these tests performed at the standard preassessment visit, depending on the site local procedure for surgical preassessment.
**The CSRI is a questionnaire for collecting retrospective information about study patients’ use of health and social care services, accommodation and living situation, income, employment and benefits.17
††Patient reported complications only.
CDVA, corrected distance visual acuity; CSRI, Client Service Receipt Inventory; ETDRS, Early Treatment Diabetic Retinopathy Study; UDVA, uncorrected distance visual acuity.