Corneal Endothelial Cell Loss After Endocapsular and Supracapsular Phacoemulsification: The PERCEPOLIS Randomized Clinical Trial

Abstract

Purpose: Subluxation techniques are superior to divide-andconquer in procedure duration, pain, and ultrasound quantity, but their safety in endothelial cell loss (ECL) is unclear. This randomized single-blind noninferiority clinical trial aimed to determine whether subluxation supracapsular phacoemulsification techniques are inferior to a reference endocapsular technique (divide-andconquer) regarding postoperative corneal ECL.Methods: Patients (aged18 years or older) with greater than +0.2 logarithm of the minimum angle of resolution best spectacle-corrected visual acuity and normal to severe density cataract were randomized to subluxation or divide-and-conquer phacoemulsification in 2015 to 2016. Follow-up with ophthalmic tests was conducted on day 4 and months 1, 3, and 12. The primary study outcome was ECL at all time points. Secondary study end points were operative variables, including effective phaco time and procedure duration. A clinically relevant noninferiority ECL limit was established on the basis of the literature.Results: In total, 292 patients (mean age, 73 yrs; 59% female) were randomized and underwent subluxation (n = 148) or divide-andconquer (n = 144). Day 4 and month 1, 3, and 12 data were available for 243, 270, 275, and 198 patients, respectively. The unexpectedly high dropout at 12 months meant that the 12-month ECL data could only be assessed qualitatively. Surgery was successful in all patients. Subluxation was noninferior to divide-and-conquer in ECL. Effective phaco times were similar, but subluxation associated with shorter procedure duration. Conclusions:The subluxation technique was noninferior to divideand-conquer regarding postoperative ECL, at least in the first 3 months, and associated with reduced intervention time. Subluxation techniques may be suitable alternatives to endocapsular techniques.

Corneal Endothelial Cell Loss After Endocapsular and Supracapsular Phacoemulsification: The PERCEPOLIS Randomized Clinical Trial

“…We read with interest the article entitled “Corneal Endothelial Cell Loss After Endocapsular and Supracapsular Phacoemulsification: The PERCEPOLIS Randomized Clinical Trial.“ 1 The findings of this well-designed study support the noninferiority of a subluxation technique compared with standard in-the-bag phacoemulsification.…”

Narrative review after post-hoc trial analysis of factors that predict corneal endothelial cell loss after phacoemulsification: Tips for improving cataract surgery research

“…It was approved by the Ethics Committee of the French Society of Ophthalmology (IRB 00008855 Société Française d’Ophtalmologie IRB#1) and adhered to the tenets of the Declaration of Helsinki. All subjects provided written informed consent before randomization [ 50 ].…”

“…DAC is an endocapsular method where the nucleus is fractured into four quadrants in the capsular bag and then removed [ 49 ]. Our RCT showed that subluxation is non-inferior to DAC in terms of ECL at 3 months [ 50 ]. In the present study, we conducted a post-hoc analysis of these trial data to assess the ability of nine demographic, preoperative, and perioperative variables to predict ECL 3 months after phacoemulsification.…”

Letter Regarding: Corneal Endothelial Cell Loss After Endocapsular and Supracapsular Phacoemulsification: The PERCEPOLIS Randomized Clinical Trial

“…Secondary outcome analysis also showed that the effective phaco times were similar but subluxation associated with significantly shorter procedure duration. 4…”

“…Secondary outcome analysis also showed that the effective phaco times were similar but subluxation associated with significantly shorter procedure duration. 4 Knutsson et al first noted that our analyses did not include the fluid volume used during the procedure, which is known to contribute to ECL. 5 We agree that this is a study limitation and are addressing it with a large prospective study that is currently underway in our department.…”