European study underscores trend towards immediate sequential bilateral cataract surgery.
Rudy MMA Nuijts MD, PhD
Immediate sequential bilateral cataract surgery (ISBCS) offers comparable safety and efficacy to delayed sequential bilateral cataract surgery (DSBCS) and may confer other cost advantages as well, according to a major Dutch study presented at the 25th ESCRS Winter Meeting.
“The clear take-home message is that ISBCS shows comparable safety and effectiveness versus DSBCS. There are also lower costs for ISBCS, but we still need more analysis to determine the true cost-effectiveness of the procedure,” said Rudy MMA Nuijts MD, PhD, Professor of Ophthalmology, Vice-Chairman, and Director of the Cornea Clinic and the Centre for Refractive Surgery at the University Eye Clinic Maastricht, Maastricht Medical University, The Netherlands.
Prof Nuijts presented data from the bilateral cataract surgery in the Netherlands (BICAT-NL), a multicentre randomised controlled trial with non-inferiority design carried out at 10 hospitals in the Netherlands, with 865 patients randomised for either ISBCS or DSBCS.
The primary outcome of the study was to evaluate whether ISBCS is non-inferior to DSBCS, with effectiveness defined as the proportion of patients with a postoperative refraction within 1.0D of target refraction.
“This outcome was chosen because it is an indicator for insurance companies in the Netherlands to evaluate how well cataract surgery has been performed,” explained Prof Nuijts.
Secondary objectives included the proportion of patients with a postoperative refraction within 0.5D of target refraction, postoperative visual acuity, patient satisfaction using patient-reported outcome measures (PROMs), incidence of complications and cost-effectiveness.
The guidelines followed for surgery were in line with the ISBCS General Principles for Excellence, said Prof Nuijts, with strict separation of procedure, instruments and intraocular medication for right and left eye.
Turning to the results, the number of eyes within 1.0D of target refraction was around 97% for both groups and there was no statistical difference either for eyes within 0.5D in both groups. The uncorrected and best-corrected visual acuity outcomes were also similar between the two groups, said Prof Nuijts.
In terms of adverse events, there were no cases of endophthalmitis, one case of bilateral corneal decompensation (DSBCS patient) which developed six weeks after surgery, one case of bilateral uveitis (ISBCS patient) which developed at 10.5 weeks after surgery and one case of bilateral macular oedema (DSBCS patient), which developed at 4.5 weeks after surgery. There were also comparable mild adverse events for ISBCS versus DSBCS such as dry eye and dysphotopsias.
For total operating room (OR) time, there was not a lot of difference between the two groups.
“This was a bit surprising to us as we expected there to be less time for ISBCS, yet only one centre showed a clear advantage for ISBCS. I think this shows that most centres have organised their patient flow very efficiently in the Netherlands,” he said.
Costs were also less for ISBCS, with a difference of around 620 euros per procedure coming from reduced day admission costs, visits to ophthalmologists and eye drops, he said.
Prof Nuijts said that the outcomes of the study reflect the growing interest in ISBCS at a time of shrinking healthcare budgets and increased demographic pressure on practitioners to deliver quality eyecare as efficiently as possible.
“The COVID-19 pandemic has sparked a lot of interest in ISBCS over the past year and we have seen a lot of debate in the academic journals concerning the pros and cons of this approach,” he said.
Prof Nuijts cited a recent editorial in Ophthalmology (Ahmed I et al., Ophthalmology2021 Jan;128(1):13-14) arguing that ISBCS is less expensive, more efficient and provides faster visual recovery than traditional delayed bilateral surgery. They also argue that the cost efficiency is greater due to less patient costs for travel, less home care and decreased absence from work.
“They reported no cases of bilateral endophthalmitis or TASS in a series of over 95,000 ISBCS surgeries. The refractive outcomes were enhanced when using the latest generation formulas such as the Barrett Universal II. In their opinion patients should be given an informed option between ISBCS and DSBCS,” he said.
The counter argument outlined in another editorial by Samuel Masket (Masket S. Ophthalmology. 2021;128(1):11-12) is that ISCBS poses a risk for potentially blinding complications such as endophthalmitis or TASS and there is no justification for placing the surgeon at greater medicolegal risk with ISBCS.
“He also suggests there is a risk of a wrong power IOL as the first eye cannot be properly evaluated before second eye surgery. There is also a greater risk of negative dysphotopsia in both eyes. He argues that the benefits disappear if second eye surgery is performed within two days. There are also adoption hurdles: surgeons are financially penalised for ISBCS, leaving the bulk of the benefit to third-party payers,” said Prof Nuijts.
Although guidelines in the Netherlands officially prohibit ISBCS, the reality is that some surgeons are already performing such procedures and the demand is growing, said Prof Nuijts.
“We performed a survey last year in the Netherlands and some 26% said they currently perform ISBCS for a small percentage of cases despite the fact that it is not officially allowed. When we asked if they would consider performing ISBCS in the near future, the answer was yes for 46%, which underlines the interest in the procedure,” he said.
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