FACT: laser-assisted versus standard ultrasound cataract surgery

• Register: ISRCTN
• Last refreshed on: 16 February 2021
• Main ID: ISRCTN77602616
• Date of registration: 06/01/2015
• Prospective Registration: Yes
• Primary sponsor: University College London
• Public title: FACT: laser-assisted versus standard ultrasound cataract surgery
• Scientific title: The FACT trial: a randomised comparison of Femtosecond laser-assisted vs. manual phacoemulsification CataracT surgery for adults with visually significant cataract
• Date of first enrolment: 01/05/2015
• Target sample size: 808
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN77602616
• Study type: Interventional
• Study design: Pragmatic randomised controlled non-inferiority trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Vicky McCudden

• Name: Mark Wilkins

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Symptomatic age-related cataract
Eye Diseases
Senile cataract

Intervention(s)

Arm A: manual phacoemulsification cataract surgery in the study eye
Arm B: laser-assisted phacoemulsification cataract surgery in the study eye

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

14/0609; HTA 13/04/46

Source(s) of Monetary Support

National Institute for Health Research

Ethics review

Status:
Approval date:
Contact:

NRES Committee London - City Road & Hampstead, 06/02/2015, ref: 14/LO/1937

Results

• Results available: Yes
• Date Completed: 28/02/2018