Bilateral Cataract Surgery

Superior cost-effectiveness builds the case for immediate sequential procedure. Howard Larkin reports

Will we all be doing immediate sequential bilateral cataract surgery (ISBCS) in the near future? For appropriate cases, probably yes, according to Dutch investigator Rob WP Simons MD.

Refractive outcomes and complication rates are similar between immediate sequential bilateral cataract surgery (ISBCS, same-day bilateral cataract surgery) and delayed sequential bilateral cataract surgery (DSBCS, surgery on both eyes delayed by days or even weeks), according to a multicentre randomised clinical trial in the Netherlands. However, ISBCS significantly reduces costs and slightly improves patient quality of life compared with DSBCS.

The BICAT-NL study results involving 865 patients at 10 hospitals confirm findings of several non-randomised studies comparing the safety, efficacy, and costs of the two approaches. Together they increase pressure to adopt ISBCS for select patients on the grounds of superior cost-effectiveness—though barriers including restrictions in national guidelines and lower payments for immediate sequential procedures also must be overcome.

SIMILAR OUTCOMES Questions about ISBCS versus DSBCS involve the trade-off between the potential advantages and disadvantages. Results of the Dutch study suggest the advantages of ISBCS, primarily improved quality of life and lower costs, outweigh the disadvantages, primarily risk of a “refractive surprise” or bilateral complications.

To assess “refractive surprise” and overall efficacy, BICATNL used a non-inferiority design with a primary outcome of postoperative refraction of the second eye within 1.0 D of target. Of 834 second eyes treated, 96.9% of ISBCS eyes and 97.6% of BSBCS eyes were within 1.0 D, while 79.4% and 77.2% were within 0.5 D, respectively.

These refractive findings are similar to published studies, of which two found between 91% and 97% of ISBCS eyes and 90% to 97% of DSBCS eyes were within 1.0 D. Three studies found 63% to 71% of ISBCS eyes and 61% to 81% of DSBCS eyes within 0.5 D.

Regarding safety, no cases of endophthalmitis occurred in either BICAT-NL group. As for serious bilateral complications, one DSBCS patient developed corneal decompensation 6 weeks after surgery, another developed bilateral cystoid macular oedema 4.5 weeks after surgery, and one ISBCS patient developed bilateral uveitis 10.5 weeks after surgery. Mild adverse events such as dry eye and dysphotopsias were similar between the two groups. These results also are consistent with five other studies in which complication rates were similar between the two approaches—with one study finding one unilateral case of endophthalmitis in 10,494 ISBCS eyes and two unilateral cases in 38,736 BSBCS eyes.

“We can conclude ISBCS is not inferior to DSBCS when it comes to refractive outcomes and the rate of complications,” Dr Simons said.

LOWER COSTS BICAT-NL took a comprehensive approach to measuring costeffectiveness associated with both cataract procedures, Dr Simons said. Costs were approached from a societal perspective with all costs over a three-month period included, no matter who incurred them. These included healthcare costs, such as operating room time, outpatient visits, medication, and home care, as well as patient costs for travel, informal care, and loss of productivity for both patients and any caregivers. Data were collected using questionnaires and patient records.

Overall, mean ISBCS total cost was €1,561 per patient, or €403 less than the €1,964 mean cost per DSBCS patient, a savings of 20.5%. One less admission day and fewer postoperative visits accounted for €354 of the total savings. These results were in line with the 12% to 30% savings for ISBCS reported by five other studies using various methodologies Dr Simons summarised.

Effectiveness was measured using the EQ-5D-5L survey, which assesses five quality of life domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and the HUI-3 survey, which assesses eight quality of life domains, including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. Slightly higher HUI-3 scores translated into 0.193 quality-adjusted life years (QALYs) for the ISBCS group compared with a 0.186 QALYs for ISBCS out of a maximum achievable 0.25 during 13 weeks of follow up. Results were similar for EQ-5D-5L findings, with ISBCS resulting in 0.215 QALYs, slightly more than DSBCS with 0.212 QALYs. Further analysis of the costs and QUALYs showed a probability of 100% that ISBCS is cost-effective compared with DSBCS, leaving very little uncertainty about the results of the study Dr Simons said.

“Will we all be doing ISBCS because it is more cost effective? I think the answer is ‘yes,’ but in a select group of patients,” Dr Simons said. Patients should have no increased risk of endophthalmitis, refractive surprise, or other complications. “Patients with previous refractive surgery or severe blepharitis may not be suitable candidates.” Surgeon experience is also an important factor, he added.

To make ISBCS safer and reduce the risk of bilateral complications, Dr Simons stressed the importance of adhering to the International Society for Bilateral Cataract Surgery’s general principles for excellence. These include strict aseptic preparation, use of separate instruments from different sterilisation cycles, different lot numbers for medications for each eye, and use of intracameral antibiotics.

Participating testing centres across the Netherlands.

This study was presented at the 39th Congress of the ESCRS in Amsterdam, the Netherlands.

Rob WP Simons MD is an ophthalmologist at Zuyderland Eyescan Oogzorgkliniek, SittardGeleen, the Netherlands. robsimons87@gmail.com