Posters

AmnioClip-plus makes amniotic membrane transplantation without trauma possible

Poster Details

First Author: N.Hofmann GERMANY

Co Author(s):    I. Wittmershaus   K. Becke   K. Hofmann   K. Engelmann   M. Börgel        

Abstract Details

Purpose:

Defects of the cornea, often caused by surface disorders of the eye, are difficult to treat. A consequence is clouding of the cornea with a subsequent visual loss or blindness. Wound healing is often time-consuming and protracted. Ointments and local therapies are necessary, which is why hospitalization is often required. In addition to the pharmacological therapy, amniotic membrane transplantation (AMT) has been proved as an excellent treatment option for surface disorders of the cornea. However, a major disadvantage of AMT is that the membrane must be fixed on the ocular surface with sutures, which causes an extra trauma or bleeding.

Setting:

To avoid this additional surgical trauma, an interdisciplinary team developed a sutureless method. They designed a medical device for clamping the amniotic membrane (AM) into a ring system (AmnioClip). AM is donated and obtained after caesarean section. It can be stored lyophilized or cryopreserved for a longer period of time.

Methods:

The AM-ring system can easily be used in a similar way to a contact lens. A clamping device facilitates the handling of the thin AM. For the AmnioClip ring system, only materials approved by the Medicinal Products Act for use in humans were used. The ready-to-use combination of the medical product and the AM (human tissue) – the so-called "AmnioClip-plus" (AC+) – is prepared under standardized conditions in a clean room of a tissue bank.

Results:

AM possess anti-inflammatory, anti-angiogenic and antifibrotic properties, resulting in significant reduction of scarring and promotion of wound healing. AC+ combines the valuable properties of AM with a simple, easy-to-repeat method of application by being placed on the eye surface under local anesthesia. The treatment of other diseases (e.g. dry eye syndrome) is also possible. In clinical practice, AC+ proved to be well tolerated and effective. The valuable factors of AM are not affected by freezing; the effect of AM in AC+ is the same as in AMT. Studies even show that they are particularly well preserved by native freezing.

Conclusions:

With AC+ ophthalmologists could treat more patients with the valuable AM without causing any additional trauma. A particular challenge in the development of the AC+ was the extensive approval procedure by the senior federal authority (Paul Ehrlich Institute). Even if the individual components have proven to be harmless or are already approved as a drug, a completely new test series must be carried out for the combined product.

Financial Disclosure:

None