Researchers have developed a prosthetic capsular bag (PCB) for posterior scleral fixation of an intraocular lens (IOL) in eyes without capsular support, with a recent study demonstrating its viability.
Fifteen patients underwent PCB fixation with secondary IOL placement, with one device-related serious adverse event reported. A patient with Marfan’s syndrome experienced reinternalization of a single footplate, which required secondary surgical intervention to refixate the footplate. None of the participants suffered conjunctival erosion over the footplates or IOL dislocation from the PCB.
Of the patients, 93 percent demonstrated best-corrected visual acuity (BCVA) within 1 line of the screening BCVA. Uncorrected visual acuity (UCVA) improved 12 lines on average, while 71 percent of patients showed UCVA within 2 lines of the screening BCVA.
Notably, the PCB delivered reliable refractive outcomes, with a mean spherical equivalent of 0.12 dioptres.
“Additional studies are planned to confirm these findings,” the researchers said.
This multicentre, prospective, open-label, single-arm study recruited patients with insufficient capsular or zonular integrity, or both, to support an IOL from three retina practices in Australia.
Eligible participants underwent pars plana vitrectomy with removal of dislocated crystalline lens or IOL as needed. The PCB was inserted via standard IOL injector with or without a preloaded IOL and was secured transsclerally using three fixation arms without the use of sutures or scleral pockets.
“Fixation approaches for secondary IOLs in the absence of capsular support are varied and technically challenging and can lead to high rates of complications,” the researchers said. “A scleral-fixated PCB was developed to provide secure, sutureless fixation of posterior chamber IOLs.”