A Randomised Comparison of Femtosecond Laser Assisted vs Manual Phacoemulsification Cataract Surgery for Adults with Visually Significant Cataract: The FACT trial
Recipient organisationMoorfields Eye Hospital NHS Foundation Trust
Funding£1.5M
PeriodSept 2014 — Oct 2019
In plain English
AI plain-English summary
A new trial is directly comparing laser-assisted cataract surgery against the standard ultrasound method to see which produces sharper vision with fewer complications. Cataract surgery is the most common operation performed by the NHS, but the standard technique has known risks. A small percentage of patients experience serious complications such as posterior capsule rupture, which can lead to long-term poor outcomes, further surgery, and a higher risk of retinal detachment. Even minor complications can be distressing because vision is so critical for daily activities. Laser systems can make the incisions and fragment the cataract in about one minute, potentially offering greater precision and reproducibility than manual surgery. If the laser proves superior, it could reduce complication rates and the need for repeat operations, offsetting the high cost of the equipment. For patients, this would mean safer surgery, faster recovery, and better unaided vision—possibly meeting the standard required for driving without glasses. For the NHS, fewer complications would mean fewer follow-up appointments, less additional treatment, and lower long-term costs for the health service.
View original technical description
Cataract is one of the leading causes of low vision in the UK. Cataract surgery is the most commonly performed operation by the NHS with over 310,000 procedures in 2011-12 at an approximate cost of £250 million. The current surgical method introduced over 20 years ago uses ultrasound (phacoemulsification) to help remove the cataract. Following surgery, 91% achieve a Snellen visual acuity of 6/12 (the minimum required for driving, 0.30 logMAR) and 46% achieve Snellen 6/6 (0.00 logMAR, 20/20 equivalent in the United States, perceived as normal vision. The overall complication rate for cataract surgery is 7.4%. Complications can affect recovery and some are serious and associated with long term poor outcomes; eg. posterior capsule rupture/ vitreous loss (PCR/VL) that occurs in ~1.9% cases. Of these one third of patients have complaints about their eye & vision 3.5 years after surgery. One in 5 cases need further surgery and there is a 15 times higher risk of retinal detachment within 3 years. The surgical learning curve is associated with complications, with a 3.7 and 1.6 times higher risk of PCR/VL for SHOs and SpRs respectively. Other complications, the majority of which are less serious, may mean a longer operation and delayed healing with additional appointments and eye drops. Patients can be devastated when suffering a complication and due to the importance of vision for daily activities, can find even minor complications very distressing. Laser systems are now available that can make the incisions, open the lens capsule and fragment the cataract in 1 minute, leaving only removal lens fragments and insertion of the lens implant to be done by the surgeon. The potential advantages are broad and include better visual outcomes through greater precision and reproducibility and improved safety. These systems are expensive, however costs may be mitigated by fewer complications, less repeat surgery and better outcomes. DESIGN: Multi-centre randomised controlled trial of laser versus manual phacoemulsification cataract surgery with an internal pilot. SETTING: Secondary care. NHS cataract day surgery units in England including St Ann's Hospital, Tottenham, London TARGET POPULATION: Adults with age related cataract. HEALTH TECHNOLOGY BEING ASSESSED: Intervention: Laser assisted cataract surgery Control: Phacoemulsification cataract surgery (standard care) INCLUSION/ EXCLUSION CRITERIA: Inclusion criteria: Symptomatic age related cataract, one or both eyes. Patients must be sufficiently fluent in English for informed consent and completion of the health state questionnaires. Willing to attend follow-up appointments at 4 and 12 months after cataract surgery. Exclusion criteria: Secondary causes of cataract, previous cataract or glaucoma surgery, unable to give consent or unable to attend follow-up assessment, unable to be positioned for surgery, scheduled to undergo combined surgery eg. cataract and trabeculectomy. These inclusion and exclusion criteria have been kept to a minimum to ensure the trial is representative of clinical practice. MEASUREMENT OF OUTCOMES AND COSTS: All outcomes will be assessed at 4 & 12 months after surgery by a masked hospital Optometrist. The study eye is defined as the 1st eye to undergo cataract surgery. Primary: - Uncorrected distance visual acuity (UDVA) at 4 months after surgery in the study eye (logMAR chart at 4 meters). Secondary - UDVA at 12 months in the study eye. - Corrected distance visual acuity (CDVA) at 4 & 12 months in the study eye. - UDVA, CDVA and complications in the second eye within 4 & 12 months of surgery for patients with bilateral cataracts. - Ocular complications within 4 & 12 months of cataract surgery in the study 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. - Residual refractive error
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