Safety and Efficacy of the Presbyopic IPCL for correction of Presbyopia with Moderate Myopia and Hyperopia Prospective Clinical Trial

Correction of presbyopia remains the major vision problem not adequately addressed by modern refractive surgery**.**Presbyopia is a multifactorial anatomic problem that leads to a progressive functional loss of the human eye’s ability to focus at near and results in the use of and dependence on near vision spectacles by age 40 to 50 years.Multifocal posterior chamber intraocular lenses (IOLs) have been used in the correction of aphakia for a relatively long period1, providing functional far, intermediate, and near vision and obviating the need for spectacles for near vision in many cases.Presbyopia is frequently associated with other refractive errors, including myopia, hyperopia, and astigmatism. When a presbyopic patient selects refractive surgery, the choices are limited.Refractive lens exchange with a multifocal intraocular lens was a popular method of refractive surgery in presbyopic patients, However near vision in these cases is attained by pseudoaccomodation. Other complications include posterior capsular opacification and retinal detatchment4. A phakic IOL with multifocal refractive technology therefore is an attractive option. In  a pilot study done by Jorge L et al2in the year 2005, in which the potential of an anterior chamber phakic refractive multifocal intraocular lens (IOL) prototype for the correction of near and far vision in those with myopic and hyperopic presbyopia was studied, they found, promising results were obtained with the refractive multifocal phakic IOL prototype. In another study by Caroline Amaral Ferraz et al,done in 2007,similar results with respect to improvement of mean uncorrected visual acuity and refraction data after multifocal phakic intraocular lens Newlife implantation for presbyopia correction was observed. However, established safety criteria (distance and near corrected visual acuity, endothelial cell count and complications) did not confirm the safety of the procedure in the follow-up period.

There are no published studies on posterior chamber presbyopic phakic IOLs, regarding its efficacy or its safety profile.

A single study presented at ESCRS Barcelona in 2015, including 5 patients in whom posterior chamber presbyopic phakic IOL were implanted, 4 patients had a UDVA of 1.0 and an uncorrected near visual acuity (UNVA) of  J-1, one patient developed cataract. The mean endothelial cell loss at the end of 1 year is 10%. In a single case with flipped IOL, the endothelial loss was 25%, from 2400 to 1800 at the end of 1year. The specifications of the Presbyopic IPCL manufactured by Contacare are as follows,

The lens device is structurally designed to be implanted in the posterior chamber of the eye. It comprises of a circular optic, two flat haptics placed radially opposite sides of the optic and a vaulted section connecting the optic to the haptic. Each haptic has at least 3 outward protruding pads for fixating the haptic structures in the ciliary sulcus. The vaulted section and the optical section and a transition zone between the two, have at one opening each to allow fluid to pass from between the anterior and posterior chamber. The optical zone consist of concentric annular zones having surfaces separated by slanted steps having surfaces where in the surface of the the concentric zones effect both diffraction and refraction of the incident light while the surface of the steps are devoid substantially devoid of these.

The IPCL is DGCI approved on 16/10/2014 . The implant has also received CE certification on 29 October 2013

**Lacunae in knowledge:**No long term study has been done to evaluate the safety and efficacy of  the IPCL to correct Presbyopia with Moderate  Myopia & Hyperopia (with or without astigmatism).

**Objective of the study:**To report the safety and efficacy outcomes of the IPCL to correct presbyopia with moderate  Myopia & Hyperopia    (with or without astigmatism) at minimum 3 years follow-up duration