Development and Evaluation of a Device for Sutureless and Repeated Application of Amniotic Membrane Overlays

Abstract

To develop a prototype device for sutureless and repeated ocular surface treatments with overlay amniotic membranes and to describe the main results of various prototype modifications. In this experimental, descriptive study, various modifications of a ring-like device were designed and manufactured. The different variants were tested for comfort, local stability, and corneal contact. The final prototype was photographed during different ocular deviations and investigated at a slit lamp for the fit of the device within the fornices and the integrity of the membrane on the ocular surface. Ultrasound was performed with the final prototype to document the distance between the corneal surface and the amniotic membrane that was sutured to the device. The main outcome measures were feasibility of the device setting into the regular fornices, corneal contact of the device during different ocular deviations, comfort, and local stability during 7 days of continuous wearing. One prototype with five modifications was manufactured and tested. An amniotic membrane patch was sutured onto the final prototype and laid into the fornices of a human eyeball during 7 days of continuous wearing. On slit-lamp examination, the amniotic membrane always appeared attached to the complete human cornea and limbal region without macroscopically visible wrinkling. No side effects were observed. The final ellipsoid device enables sutureless and repeated treatment with amniotic membrane overlays and was comfortable in one patient during 7 days of continuous wearing. Limitations of the device such as in cicatriceal foreshortening and possible therapeutic effects need to be determined in future studies.