Efficacy and safety analysis of an intraocular lutein-based dye for cataract surgery in preclinical and clinical models

Session Details

Session Title: Cat Surgery Equipment/inst/OVD

Session Date/Time: Tuesday 16/09/2014 | 16:30-18:00

Paper Time: 16:53

Venue: Boulevard B

First Author: : I.Laíns PORTUGAL

Co Author(s): :    J. Figueira   D. Sousa Martins   J. Lencart   R. Belfort   M. Maia  

Abstract Details

Purpose:

To investigate the preclinical and clinical efficacy and safety of a novel dye, composed of lutein in association with a low percentage of trypan blue, for staining the anterior lens capsule (AC) during phacoemulsification cataract surgery.

Setting:

Department of Ophthalmology, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.

Methods:

The preclinical efficacy of a lutein-based dye (Phacodyne™) was tested in fifty-two human cadaveric eyes undergoing cataract surgery. The dye solutions were in contact with the anterior capsule for 30 seconds. Afterwards, they were washed-out with balanced salt solution (BSS) and a 360º capsulorhexis was performed, with the removal of the stained AC from the unstained lens. The specimens were examined by light and electron transmission microscopy. The lutein-based dye was also tested in 25 eyes of 25 patients, submitted to phacoemulsification cataract surgery by 25 different ophthalmologists, who performed continuous circular capsulorhexis (CCC) guided by Phacodyne™. All surgeons answered a questionnaire to evaluate their opinion about the efficacy of the dye. Follow-up examinations were performed 1, 7 and 30 days postoperatively. Eyes were evaluated by complete ophthalmologic examination, corneal topography/pachymetry and corneal endothelial cells count.

Results:

In the preclinical study, contact between the lutein-based dye and the AC resulted in its greenish blue staining, which improved the execution of the CCC, with no histologic signs of toxicity. Regarding the clinical study, the performed questionnaire revealed that all surgeons considered that the dye facilitated the CCC procedure. Baseline nuclear cataract classification (according to LOCS III) was 3.24 (±1.12). Preoperative best-corrected visual acuity (logMAR) was 0.89±0.59 and improved to 0.23±0.22 at day 30 after surgery (p<0.0001). The intraocular pressure (IOP) remained stable and a mild inflammatory reaction disappeared in all cases within the 7 first days after surgery. There were no statistical significant differences regarding corneal pachymetry and IOP on day 30, when compared to the preoperative values. The preoperative endothelial cells count average was 2573.5±235.9 cell/mm2 and the postoperative was 2311.36±490.7 cell/mm2, showing an average decrease of 10.18% of endothelium cells in the first month after the surgical procedures. Such behavior of endothelial cells loss was similar to reports with or without the use of trypan blue during phacoemulsification.

Conclusions:

The natural dye solution based on lutein combined with trypan blue efficiently stained the AC in human cadaveric eyes. In the clinical setting, this new dye proved to be efficient for anterior capsulorhexis during cataract surgery by phacoemulsification. Additionally, it showed no signs of toxicity or side effects after 30 days of follow-up, confirming the excellent safety profile observed in previous cell line model studies.

Financial Interest:

One or more of the authors... is employed by a forNONEprofit company with an interest in the subject of the presentation, One or more of the authors... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented