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Evaluation Studies
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Evaluation of an integrated orbital tissue expander in congenital anophthalmos: report of preliminary clinical experience.
American Journal of Ophthalmology 2011 March
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.
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.
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