ArticleUse of a calibrated force gauge in clear corneal cataract surgery to quantify point-pressure manipulationMasket, Samuel MD∗; Hovanesian, John MD; Raizman, Michael MD; Wee, Daniel MD; Fram, Nicole MD Author Information From Advanced Vision Care (Masket, Fram), Los Angeles, and Harvard Eye Associates (Hovanesian), San Clemente, California, and Ophthalmic Consultants of Boston (Raizman, Wee), Boston Eye Surgery & Laser Center, Waltham, Massachusetts 02451, USA ∗Corresponding author: Samuel Masket, MD, Advanced Vision Care, 2080 Century Park East, Suite 911, Los Angeles, California 90067, USA. E-mail: [email protected] Submitted April 25, 2012; revised October 10, 2012; accepted October 16, 2012. Supported by Ocular Therapeutix, Bedford, Massachusetts, USA. Julie Crider, PhD, provided writing assistance. Ocular Therapeutix, Inc. funded the medical writing support for this article.Figure: No Caption available.First author: Samuel Masket, MD Private practice, Los Angeles, California, USA Journal of Cataract & Refractive Surgery: April 2013 - Volume 39 - Issue 4 - p 511-518 doi: 10.1016/j.jcrs.2012.10.046 Buy Metrics Abstract Purpose To develop and evaluate a calibrated force gauge designed to simulate the effect of patient-induced manipulation of the eye with resultant elevation of intraocular pressure (IOP) and use the device to determine the stability of cataract incisions. Setting Three private practice study sites. Design Clinical trials. Methods A calibrated force gauge was developed to apply controlled and quantifiable amounts of force to the eye. In study 1, the calibrated force gauge was used to evaluate the change in IOP during application of 1 oz of external force in a group of healthy volunteers. In studies 2 and 3, the calibrated force gauge was used to assess wound leakage of clear corneal incisions that were subjected to stromal hydration or sutures, respectively. Results In study 1, with the application of 1.00 oz of external force, the mean IOP rose from a baseline of 17.49 mm Hg to 43.44 mm Hg. In study 2 (stromal hydration) using up to 1.00 oz of force, the leak rate was 67% for the main incision. The overall leak rate for study 3 (sutures) using up to 1.00 oz of force was 23.8%. No adverse events or serious adverse events occurred during these studies. Conclusions Study 1 confirmed that 1.00 oz of force is a realistic approximation of the amount of force a patient's eye may experience during rubbing. After clear corneal cataract surgery, the application of 1.00 oz of force to the ocular surface for approximately 2 to 3 seconds may simulate the propensity for postoperative wound leak resulting from patient manipulation. Financial Disclosure Drs. Masket, Hovanesian, and Raizman are consultants to Ocular Therapeutix. Dr. Masket is also a medical monitor for Ocular Therapeutix. Drs. Hovanesian and Masket are shareholders in Ocular Therapeutix. Drs. Wee and Fram have no financial disclosures. © 2013 by Lippincott Williams & Wilkins, Inc.
