Evaluation of an Integrated Orbital Tissue Expander in Congenital Anophthalmos: Report of Preliminary Clinical Experience in Seven Patients

Abstract

 

Purpose:

 

To evaluate safety and efficacy of the Orbital Tissue Expander (OTE) in managing congenital anophthalmia. The OTE, cleared for use by the FDA, is an inflatable polymeric globe delivering uniform pressure in the orbital cavity for bone induction. The proof-of-concept study was conducted at the Bascom Palmer Eye Institute and at Innovia LLC, and the safety & efficacy of the device were demonstrated in a feline anophthalmic model (ARVO 2005, ARVO 2008). This study presents the preliminary findings in 7 patients with clinical anophthalmos after 1 to 2 years of follow-up.

 

Methods:

 

7 patients age range 1 to 10 years with unilateral anophthalmos were implanted with the OTE. 4 of the 7 patients have had several orbital procedures prior to OTE placement. The implanted OTE was inflated with an initial average volume of 2.6 ± 0.7 ml (see figure 1) of sterile saline. At least 1 follow up and further inflation have been performed to date. The average volume after the first follow up is 3.8 ±1.2 ml (see figure 1) of sterile saline. Equivalent Orbital volume expansion was assessed by axial and coronal CT scan measurements.

 

Results:

 

No infection or pain has been noted on any of the seven patients. All patients have demonstrated an increase in orbital volume expansion with the OTE when compared to the CT before the device implantation.

 

Conclusions:

 

OTE implantation and serial inflation are simple to implement. It is well tolerated by patients and does not interfere with concurrent fornix expansion. This device eliminates the need for multiple implant exchanges and demonstrates salutary effects in inducing anophthalmic socket bone growth. Additional patients and longer follow-up data are needed to validate the efficacy of this new treatment approach.  

 

Keywords: clinical (human) or epidemiologic studies: outcomes/complications • orbit • wound healing