Acknowledgement
The authors thank Dale Heuer for critically reviewing the manuscript.
Study Sponsor: Aeon Astron Europe B.V., Leiden, The Netherlands
DATA SAFETY MONITORING COMMITTEE:
Dale K. Heuer, M.D. (Chair)
C. Gustavo De Moraes, M.D., M.P.H.
Paul F. Palmberg, M.D., Ph.D.
Sylvia W Smoller, Ph.D.
STATISTICIAN:
Alfred W. Rademaker, Ph.D.
STUDY INVESTIGATORS:
Robert Ritch, M.D.
Glaucoma Associates of New York
310 East 14th Street, New York, NY 10003
Phone: 212-673-5140
Email: [email protected]
Angelo P. Tanna, M.D.
Northwestern University Feinberg School of Medicine
645 N. Michigan Ave, Suite 440, Chicago, IL 60611
Phone: 312-908-8152
Email: [email protected]
Steven R. Sarkisian, Jr., M.D.
Dean McGee Eye Institute
608 Stanton L. Young Blvd, Oklahoma City, OK 73104
Phone: 405-271-1093
Email: [email protected]
Celso Tello, M.D., Jeffrey Liebmann, M.D., Christopher Teng, M.D.
Glaucoma Associates of New York
310 East 14th Street, New York, NY 10003
Phone: 212-477-7540
Email: [email protected]/[email protected]/
Robert D. Fechtner, M.D.
Institute of Ophthalmology and Visual Science,
UMDNJ/New Jersey Medical School
90 Bergen Street, Suite 6100, Newark, NJ 07103
Phone: 973-972-0205
Email: [email protected]
Michael Pro, M.D., Marlene Moster, M.D., Scott J. Fudemberg, M.D., L. Jay Katz, M.D., Anand Mantravadi, M.D., Jonathan S. Myers, M.D., Courtland Schmidt, M.D., George L. Spaeth, M.D.
Wills Eye Institute
840 Walnut Street, Suite 1110, Philadelphia, PA 19107
Phone: 917-254-2455/215-928-3342
Email:
Steven D. Vold, M.D./Kevin M. Gardner, O.D.
Boozman-Hof Eye Clinic, P.A.
3737 West Walnut, Rogers, AR 72756
Phone: 479-246-1700
Email: [email protected]/[email protected]
David G. Godfrey, M.D.
Glaucoma Associates of Texas
10740 N. Central Expy, Suite 300, Dallas, TX 75231
Phone: 214-360-0000
Email: [email protected]
Paul Sidoti, M.D.
New York Eye and Ear Infirmary
Address: 310 East 14th Street, New York, NY 10003
Phone: 212-477-7540
Email: [email protected]
Funding
The study sponsor, Aeon Astron Europe B.V., Leiden, The Netherlands, provided funding to each investigator’s academic institution or private practice to conduct the clinical trial. The Northwestern University Biostatistics Consultation Service received funding from the study sponsor to carry out the statistical analysis independently. The study sponsor was involved in the design of the clinical trial. The study sponsor had no role in the collection, analysis, and interpretation of data or in writing the manuscript.
Availability of data and materials
The datasets during and/or analysed during the current study available from the corresponding author on reasonable request.
Authors’ contributions
AWR performed all statistical analyses. All authors analyzed and interpreted the data, participated in manuscript preparation, read and approved the final manuscript.
Competing interests
APT: Consulting fees and travel support from the study sponsor. CGdM: Consulting fees from the study sponsor. SRS: Consulting fees from the study sponsor. RR: Consulting fees and travel support from the study sponsor. AWR, DGG, SDV: Declares that they have no competing interests.
Consent for publication
Not applicable.
Ethics approval and consent to participate
This study was approved by five Institutional Review Boards with oversight authority of the eight study sites (listed below). Written informed consent was obtained from each subject. The study followed the tenets of the Declaration of Helsinki, is in compliance with the Health Insurance Portability and Accountability Act of 1996 and is registered with ClinicalTrials.gov (NCT01440751). An independent data safety monitoring committee received regular reports on surgical outcomes and adverse events during the course of the study and at its conclusion.
Western Institutional Review Board
Wills Eye Hospital Institutional Review Board
Northwestern University Institutional Review Board
University of Oklahoma Health Sciences Center Institutional Review Board
New York Eye and Ear Infirmary Institutional Review Board
Financial disclosure
APT and RR have received travel support and consulting fees from the study sponsor. CGdM and SRS received consulting frees from the study sponsor. APT is supported by an unrestricted grant to Northwestern University from Research to Prevent Blindness, New York, NY. The Northwestern University Biostatistics Consultation Service received funding from the study sponsor to carry out the statistical analysis.