Evaluation of an integrated orbital tissue expander in congenital anophthalmos: report of preliminary clinical experience.

PURPOSE: To evaluate the effectiveness of an orbital tissue expander designed to stimulate orbital bone growth in an anophthalmic socket.

DESIGN

Retrospective, noncomparative, interventional case series.

SETTINGS: Institutional.

STUDY POPULATION: Nine consecutive patients with unilateral congenital anophthalmos.

INTERVENTION: The orbital tissue expander is made of an inflatable silicone globe sliding on a titanium T-plate secured to the lateral orbital rim with screws. The globe is inflated by a transconjunctival injection of normal saline through a 30-gauge needle to a final volume of approximately 5 cm(3). Computed tomography scans were used to determine the orbital volume. The data studied were: demographics, prior orbital expansion procedures, secondary interventions, orbital symmetry, and implant-related complications.

MAIN OUTCOME MEASURES: The primary outcome measure was the orbital volume change, and the secondary outcome measures were changes in forehead, brow, and zygomatic eminence contour and adverse events.

RESULTS

The average patient age at implantation was 41.89 ± 39.42 months (range, 9 to 108 months). The initial average volume of inflation was 3.00 ± 0.87 cm(3) (range, 2.0 to 4.0 cm(3)), and the average final volume of 4.33 ± 0.50 cm(3) (range, 4.0 to 5.0 cm(3)) was achieved. The duration of expansion was 18.89 ± 8.80 months (range, 4 to 26 months). All patients demonstrated an average increase in the orbital tissue expander implanted orbital volume of 5.112 ± 2.173 cm(3) (range, 2.81 to 10.38 cm(3)). The average difference between the volume of the implanted and the initial contralateral orbit was 5.68 ± 2.34 cm(3), which decreased to 2.53 ± 1.80 cm(3) at the final measurement (P < .001, paired t test). All implants remained inflated except for 2 iatrogenic punctures at the second inflation and 1 that was the result of implant failure. All were replaced.

CONCLUSIONS

The integrated orbital tissue expander is safe and effective in stimulating anophthalmic socket bone growth.