Ex vivo performance of bacterially-derived OVDs compared to animal-derived OVDs

Session Details

Session Title: Cornea & Miscellaneous
Session Date/Time: Friday 15/02/2019 | 10:30-12:30
Paper Time: 12:00
Venue: Room MC3

First Author: G.Kahraman AUSTRIA
Co Author(s): C. Bernhart  B. Wetzel              

Abstract Details

Purpose:

To compare the performance of bacterially-derived ophthalmic viscoelastic devices (OVDs) to the animal-derived OVDs respectively, during simulated cataract surgeries performed ex vivo in porcine eyes.


Setting:

Masked, randomized ex vivo study by experienced cataract surgeons from the European Union, USA, Japan, and Brazil.

Methods:

23 Surgeons evaluated the performance of bacterially-derived OVDs (Healon, Healon GV) compared to the animal-derived OVD. The ex vivo procedure was performed in porcine eyes in a randomized, masked fashion. The incision/OVD injection technique was performed according to the surgeon’s preference. OVD performance was evaluated on a scale (0-100 for Healon OVDs and 0-5 for Healon GV OVDs) at three surgical steps (injection, capsulorhexis, and hydrodissection). The anterior chamber volume maintenance (ACVM) was also assessed. The average score for each surgeon was calculated and compared using a non-parametric statistical analysis (Mann-Whitney). The level of significance was set to p=0.05

Results:

Mean scores for the bacterially-derived OVD ranged from 63,8 to 91,5 and 55,7 to 91,5 for the animal-derived OVD (p≥0.236). ACVM mean scores for OVD (Healon PRO) ranged from 65,8 to 84,7 during the three surgical steps, which was also similar to OVD (Healon) (p≥0.503). Mean scores for the bacterially-derived OVD ranged from 4,3 to 4,9 and 4,3 to 5,0 for the animal-derived OVD (p≥0.268). ACVM mean scores ranged from 4,7 to 4,8 during the three-surgical step and were similar for both groups (p≥0.380).

Conclusions:

In this study, statistical analysis showed no significant difference in all scores for the bacterially-derived OVDs compared to the animal-derived OVD. During simulated cataract surgery, surgeons could not distinguish a difference in the performance, injection of the OVD, capsulorhexis, or hydrodissection. In addition, the anterior chamber volume was maintained with all OVDs during these three surgical steps

Financial Disclosure:

... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented