October 2012

 

RESIDENTS

 

EyeWorld journal club

Review of "Immediately sequential bilateral cataract surgery: Safety versus delayed sequential and effectiveness"


by Karolinne Maia Rocha, M.D., and Jeffrey Goshe, M.D., Cole Eye Institute, Cleveland Clinic
 

Jeffrey Goshe, M.D.

 

This month, JCRS unveils a randomized prospective trial evaluating bilateral immediate sequential cataract surgery. I asked the Cleveland Clinic residency to assess this study.

David F. Chang, M.D., EyeWorld chief medical editor

The goals of modern cataract surgery include predictable outcomes, quick recovery, and visual function restoration. Innovative technologies with advanced phacoemulsification devices, small incisions, foldable and customized intraocular lenses, intraoperative aberrometry, and prophylactic antibiotic treatment have made modern cataract surgery safe and effective. Recently, there's been a great debate worldwide about the socioeconomic benefits, faster recovery, and health-related quality of life improvement of immediately sequential bilateral cataract surgery. However, serious complications such as the risk of bilateral endophthalmitis and potential residual refractive error are major concerns of bilateral same day phacoemulsification. In the October issue of the Journal of Cataract & Refractive Surgery, Serrano-Aguiar et al. published "Immediately sequential versus delayed sequential bilateral cataract surgery: Safety and effectiveness," a randomized multicenter clinical trial that included five health centers in Las Palmas de Gran Canaria, Spain.

Patients with bilateral visually significant cataracts and no ocular diseases were randomized to immediately sequential bilateral cataract surgery (ISBCS) versus delayed sequential bilateral cataract surgery (DSBCS) groups. The clinical trial was approved by the Institutional Review Board, Official College of Surgeons of Gran Canaria, Spain. Phacoemulsification with topical anesthesia was performed by five different surgeons from each participating clinic. The surgeries were performed in an ambulatory surgery center. Ciprofloxacin or ofloxacin was administered in combination with diclofenac sodium 2 hours before surgery followed by povidone-iodine 5% 3-5 minutes before surgery and conventional aseptic and antisepstic techniques. All patients had a 2.7 mm incision with no sutures. In the ISBCS group, a new surgical field was arranged with new gloves, gowns, surgical instruments, and viscosurgical devices. A balanced saline solution containing vancomycin or a combination of gentamicin and adrenaline was used in cases of capsule rupture. Post-op all patients received topical ofloxacin and prednisolone drops every 2 hours for 1 week and tapered to four times a day for the second, third, and fourth weeks.

Outcome measures included the incidence of intraoperative and post-op complications, uncorrected and best corrected visual acuity at 1 month post-op, and the Visual Function Index-14 (VF-14) questionnaire at 1 month and 1 year post-op. To ensure safety to the study participants, "a safety rule was initially adopted to halt the study if the overall complication rate of ISBCS surpassed the complication rate of DSBCS by 3%."

Four hundred and thirty-nine patients were randomized to the ISBCS group and 406 patients were randomized to the DSBCS group. Twenty-two patients in the ISBCS group and 15 patients in the DSBCS group did not meet the inclusion criteria. There were no significant differences in gender, age, VF-14 questionnaire, and visual acuity measurements between the ISBCS and DSBCS groups pre-op. No statistically significant differences were found in the incidence of intraoperative or post-op complications in both groups (p>.999 and p=.154, respectively).

No statistically significant differences were found in uncorrected visual acuity and corrected visual acuity in the two groups. Patients in the ISBCS group had significantly better scores in the self-perceived changes in visual function questionnaire (VF-14) at 1 month post-op when compared to the DSBCS group (p<.001). No differences were observed at 1 year after surgery. Immediate corneal edema was observed in 1.2% of eyes in the ISBCS group and 0.4% in the DSBCS group. Dry eye sensation was reported in 3.1% in the ISBCS group and 6.9% in the DSBCS group. In this multicenter, randomized clinical trial no cases of endophthalmitis, suprachoroidal hemorrhage, or cystoid macular edema were reported. The incidence of endophthalmitis after conventional cataract surgery ranges from 0.08% to 0.26%.1-4 Sutureless corneal incisions permit inflow of extraocular fluid into the anterior chamber after phacoemulsification, and it has been reported as an important risk factor for endophthalmitis.5 The use of intracameral antibiotic agents after cataract surgery has decreased the rate of culture-confirmed endophthalmitis to 0.0439%.6

The major limitation of this study is the too small sample size to provide sufficient statistical power to analyze the safety of ISBCS versus DSBCS. As suggested by the authors, a sample size of more than 3,000 patients would be necessary to assess the incidence of intraoperative and post-op complications (e.g., endophthalmitis) in both groups. Another limitation of this study is the lack of visual function measurements and refractive outcomes after 1 month post-op. Furthermore, it is unusual that no cases of cystoid macular edema were reported in the entire population, suggesting that some subtle cases may have been overlooked. This randomized clinical trial including 807 patients with bilateral visually significant cataracts indicated very low adverse events and similar long-term surgical outcomes of ISBCS when compared to DSBCS. This study has special relevance with the ongoing initiative to decrease healthcare spending both in the U.S. and abroad. Immediate sequential cataract surgery may have significant advantages both in terms of faster visual rehabilitation and reduced indirect costs (e.g., fewer post-op examinations, reduced transportation costs). The most feared complication, endophthalmitis, did not occur in this study. It will be up to patients and physicians to determine if the logistical advantages of immediate sequential cataract surgery outweigh the small risk of bilateral visual loss. This risk has been willingly accepted among the refractive surgery population, but the risks associated with bilateral intraocular surgery may warrant further caution.

References

Javitt JC, Vitale S, Canner JK, et al. National outcomes of cataract extraction: endophthalmitis following inpatient surgery. Archives of Ophthalmology. 1991;109(8):10851089.

Norregaard JC, Thoning H, Bernth P, Andersen TF, Javitt JC, Anderson GF. Risk of endophthalmitis after cataract extraction: results from the International Cataract Surgery Outcomes study. British Journal of Ophthalmology. 1997;81(2):102106.

Aaberg TM, Flynn HW, Jr., Schiffman J, Newton J. Nosocomial acute-onset postoperative endophthalmitis survey: a 10-year review of incidence and outcomes. Ophthalmology. 1998;105(6):10041010.

Doft B, Nakamura T, Walonker AF, et al. Results of the endophthalmitis vitrectomy study: a randomized trial of immediate vitrectomy and of intravenous antibiotics for the treatment of postoperative bacterial endophthalmitis. Archives of Ophthalmology. 1995;113(12):14791496.

Herretes S, Stark WJ, Pirouzmanesh A, Reyes JM, McDonnell PJ, Behrens A. Inflow of ocular surface fluid into the anterior chamber after phacoemulsification through sutureless corneal cataract wounds. Am J Ophthalmol. 2005;140(4):737-40.

Barry P, Seal DV, Gettinby G, Lees F, Peterson M, Revie CW. ESCRS Endophthalmitis Study Group. ESCRS study of prophylaxis of postoperative endophthalmitis after cataract surgery: Preliminary report of principal results from a European multicenter study. J Cataract Refract Surg. 2006;32(3):407-410.

Editors' note: The authors have no financial interests related to this article.

Contact information

Rocha: rochak@ccf.org
Goshe: goshej@ccf.org

Review of "Immediately sequential bilateral cataract surgery: Safety versus delayed sequential and effectiveness" Review of "Immediately sequential bilateral cataract surgery: Safety versus delayed sequential and
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