June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Outcomes in cataract surgery using ReSure® Sealant for the intraoperative management of clear corneal incisions:
Results from a registry evaluation for pre-specified adverse ocular events
Author Affiliations & Notes
  • Deepa Mulani
    Ocular Therapeutix, Bedford, Massachusetts, United States
  • Ranjan Malhotra
    Opthamology Associates, St. Louis, Missouri, United States
  • Y Ralph Chu
    Chu Vision Institute, Bloomington, Minnesota, United States
  • Mitchell Jackson
    Jacksoneye, Lake Villa, Illinois, United States
  • Kevin Jong
    Houston Eye Associates, Houston, Texas, United States
  • Cynthia Matossian
    Matossian Eye Associates, Doylestown, Pennsylvania, United States
  • N Timothy Peters
    Eyesight Ophthalmic Services, PA, Somersworth, New Hampshire, United States
  • Inder Paul Singh
    The Eye Center of Racine & Kenosha, Racine, Wisconsin, United States
  • Jonathan Solomon
    Bowie Vision Institute, Bowie, Maryland, United States
  • Navin Tekwani
    Tekwani Vision Center, St. Louis, Missouri, United States
  • Thomas R Walters
    Keystone Research Ltd., Austin, Texas, United States
  • Eric Ankerud
    Ocular Therapeutix, Bedford, Massachusetts, United States
  • Jamie Lynne Metzinger
    Ocular Therapeutix, Bedford, Massachusetts, United States
  • Nicole Rissman
    Ocular Therapeutix, Bedford, Massachusetts, United States
  • Jonathan H Talamo
    Ocular Therapeutix, Bedford, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Deepa Mulani, Ocular Therapeutix (E); Ranjan Malhotra, Ocular Therapeutix (F); Y Ralph Chu, Ocular Therapeutix (F); Mitchell Jackson, Ocular Therapeutix (F); Kevin Jong, Ocular Therapeutix (F); Cynthia Matossian, Ocular Therapeutix (F); N Timothy Peters, Ocular Therapeutix (F); Inder Paul Singh, Ocular Therapeutix (F); Jonathan Solomon, Ocular Therapeutix (F); Navin Tekwani, Ocular Therapeutix (F); Thomas Walters, Ocular Therapeutix (F); Eric Ankerud, Ocular Therapeutix (E); Jamie Lynne Metzinger, Ocular Therapeutix (E); Nicole Rissman, Ocular Therapeutix (E); Jonathan Talamo, Ocular Therapeutix (E)
  • Footnotes
    Support  Ocular Therapeutix supported this research.
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 1821. doi:
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    • Get Citation

      Deepa Mulani, Ranjan Malhotra, Y Ralph Chu, Mitchell Jackson, Kevin Jong, Cynthia Matossian, N Timothy Peters, Inder Paul Singh, Jonathan Solomon, Navin Tekwani, Thomas R Walters, Eric Ankerud, Jamie Lynne Metzinger, Nicole Rissman, Jonathan H Talamo; Outcomes in cataract surgery using ReSure® Sealant for the intraoperative management of clear corneal incisions:
      Results from a registry evaluation for pre-specified adverse ocular events. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1821.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract surgery patients treated with ReSure Sealant.

Methods : This was a prospective, multicenter, single-arm observational post-approval registry study, conducted at up to 40 sites in the United States. Patients were eligible for inclusion in the study if they were greater than or equal to 22 years of age, had a cataract and were expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens. ReSure Sealant was prepared and applied in accordance with the product’s accompanying Instructions for Use. The primary endpoints were the proportion of patients experiencing persistent anterior chamber cells, hypotony, ocular discomfort, and surgical re-intervention in the postoperative follow-up period; achievement of the primary endpoint was based on statistical analysis of the true proportion of eyes exhibiting any adverse ocular event occurring less than or equal to 7.5%.

Results : A total of 12 endpoint adverse ocular events were reported for 12 subjects within the cohort of 626 subjects (1.9%). The frequency of each of the primary endpoint events was low (range 0 to 0.8%). The true proportion of each primary endpoint event is less than 0.075. None of the primary endpoint events were attributed to the application of the ReSure Sealant and no event was deemed to be serious. Seven of the 12 events observed within the course of this study were mild, and the remaining 5 events were of moderate intensity. None of the events were of severe intensity. Eleven of the 12 events were determined to be related to the cataract surgery.

Conclusions : The results of the primary analysis demonstrate that the true proportion of the frequency of primary endpoint Adverse Ocular Events was well below the pre-specified threshold of 7.5%. Results of this registry confirm that the ReSure Sealant can be used safely by ophthalmologists.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

Frequency and Intensity of Primary Endpoint Analysis of Adverse Ocular Events

Frequency and Intensity of Primary Endpoint Analysis of Adverse Ocular Events

 

Overall Summary of Adverse Ocular Events

Overall Summary of Adverse Ocular Events

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