Phase ii evaluation of the ICRS1™ for the correction of myopia

Penny Asbell, R. L. Abbott, T. E. Burris, D. S. Durrie, R. L. Lindstrom, D. J. Schanzlin

Research output: Contribution to journalArticle

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Abstract

Purpose. To evaluate safely and cf'icacy for the correction of myopia Methods. The Phase II clinical trial of the ICRS (Intrastromal Corneal Ring Segments) m sighted eves involves 150 patients enrolled across six investigational sites. The ICRS was i nplanted into one eye ol each patient, with eligible subjects also receiving the ICRS in their fellow eye after a minimum waiting period of six months. Five ICRS thicknesses (0.25, 0.30, 0.35. 0.-40 and 0.45 mm) are being evaluated. Results. Available data at postoperative Month 6 (68 patients: all ring thicknesses) show that 94% of the patients had une or reeled VAs of 20/40 or better. Cycloplegic refraction SE results at Month d indicate that 77% ol he patients were within ±1 00 D of then intended correction These patients lave followed a normal postoperative course, with no significant complications. Data collection is ongoing and combined results from initial and fellow eyes will be presented at the meeting. Conclusions. Though preliminary, these Phase II results indicate that the ICR is a safe and effective alternative for the predictable reduction of myopia.

Original languageEnglish (US)
JournalInvestigative Ophthalmology and Visual Science
Volume38
Issue number4
StatePublished - Dec 1 1997

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Myopia
Mydriatics
Phase II Clinical Trials

All Science Journal Classification (ASJC) codes

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience

Cite this

Asbell, P., Abbott, R. L., Burris, T. E., Durrie, D. S., Lindstrom, R. L., & Schanzlin, D. J. (1997). Phase ii evaluation of the ICRS1™ for the correction of myopia. Investigative Ophthalmology and Visual Science, 38(4).

Phase ii evaluation of the ICRS1™ for the correction of myopia. / Asbell, Penny; Abbott, R. L.; Burris, T. E.; Durrie, D. S.; Lindstrom, R. L.; Schanzlin, D. J.

In: Investigative Ophthalmology and Visual Science, Vol. 38, No. 4, 01.12.1997.

Research output: Contribution to journalArticle

Asbell, P, Abbott, RL, Burris, TE, Durrie, DS, Lindstrom, RL & Schanzlin, DJ 1997, 'Phase ii evaluation of the ICRS1™ for the correction of myopia', Investigative Ophthalmology and Visual Science, vol. 38, no. 4.
Asbell P, Abbott RL, Burris TE, Durrie DS, Lindstrom RL, Schanzlin DJ. Phase ii evaluation of the ICRS1™ for the correction of myopia. Investigative Ophthalmology and Visual Science. 1997 Dec 1;38(4).
Asbell, Penny ; Abbott, R. L. ; Burris, T. E. ; Durrie, D. S. ; Lindstrom, R. L. ; Schanzlin, D. J. / Phase ii evaluation of the ICRS1™ for the correction of myopia. In: Investigative Ophthalmology and Visual Science. 1997 ; Vol. 38, No. 4.
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