TY - JOUR
T1 - Evaluation of an integrated orbital tissue expander in congenital anophthalmos
T2 - Report of preliminary clinical experience
AU - Tse, David T.
AU - Abdulhafez, Mohammad
AU - Orozco, Marcia A.
AU - Tse, Jeffrey D.
AU - Azab, Amr Osama
AU - Pinchuk, Leonard
N1 - Funding Information:
Publication of this article was supported in part by Research to Prevent Blindness, Inc , New York, New York; Center Grant P30-EY014801 from the National Institutes of Health , Bethesda, Maryland; Small Business Innovation Research Phase I Grant NIH-1R43-EY015016-01 from the National Institutes of Health to Innovia, LLC, Miami, Florida. Dr Tse is the inventor of the integrated orbital tissue expander, which was assigned to the University of Miami and licensed exclusively to Innovia LLC. Dr Tse receives royalties from the sale of the device by Innovia. He has received grant support from Boston Scientific Corp , Small Business Innovation Research (NIH), and the Department of Defense . Drs Tse and Pinchuk have a financial interest in the device mentioned in this article. Involved in Design and fabrication of the device (D.T.T., L.P., M.A.O.); Design and conduct of the study (D.T.T., M.H.A., L.P.); data collection (D.T.T., M.H., M.A.O., J.D.T., A.O.A.); management (D.T.T., M.H.), analysis (D.T.T., M.H., M.A.O., J.D.T., A.O.A., L.P.), and interpretation (D.T.T., M.H., M.A.O., J.D.T., L.P.) of the data; and Preparation (D.T.T., M.H., M.A.O., J.D.T., L.P.), review (D.T.T., M.H., M.A.O., J.D.T., L.P.), and approval (D.T.T., M.H., M.A.O., J.D.T., A.O.A., L.P.) of the manuscript. The study protocol was conducted with prior approval of the Research Committee of the Magrabi Eye Specialist Hospital in Cairo, Egypt, and in accordance with the provisions of the Declaration of Helsinki. Informed consent was obtained from parents after full explanation of the investigative nature of the study. William J. Feuer, Bascom Palmer Eye Institute Biostatistics Department, provided assistance with statistical analysis.
PY - 2011/3
Y1 - 2011/3
N2 - • 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. • Methods: 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 cm3. 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 cm3 (range, 2.0 to 4.0 cm3), and the average final volume of 4.33 ± 0.50 cm3 (range, 4.0 to 5.0 cm3) 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 cm3 (range, 2.81 to 10.38 cm3). The average difference between the volume of the implanted and the initial contralateral orbit was 5.68 ± 2.34 cm3, 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.
AB - • 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. • Methods: 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 cm3. 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 cm3 (range, 2.0 to 4.0 cm3), and the average final volume of 4.33 ± 0.50 cm3 (range, 4.0 to 5.0 cm3) 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 cm3 (range, 2.81 to 10.38 cm3). The average difference between the volume of the implanted and the initial contralateral orbit was 5.68 ± 2.34 cm3, 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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U2 - 10.1016/j.ajo.2010.09.009
DO - 10.1016/j.ajo.2010.09.009
M3 - Article
C2 - 21145530
AN - SCOPUS:79951809579
VL - 151
SP - 470-482.e1
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
SN - 0002-9394
IS - 3
ER -