Intrastromal corneal ring segments: Reversibility of refractive effect

P. A. Asbell, Ö Ö Uçakhan, R. L. Abbott, K. A. Assil, T. E. Burris, D. S. Durrie, R. L. Lindstrom, D. J. Schanzlin, Steven Verity, G. O. Waring

Research output: Contribution to journalArticle

49 Citations (Scopus)

Abstract

PURPOSE: To evaluate the reversibility of refractive effect following removal of the ICRS (intrastromal corneal ring segments; Intacs). METHODS: Data from 34 eyes from which ICRS were removed during United States FDA Phase II and III clinical trials were evaluated with regard to segment size, loss or change of best spectacle-corrected visual acuity (BSCVA), any change of uncorrected visual acuity (UCVA), manifest spherical equivalent refraction, manifest cylinder refraction, stability of manifest cylinder refraction, and subjective visual symptoms. RESULTS: Out of 725 initial or contralateral eyes placed with the ICRS during Phase II and III clinical trials, segments were removed from 34 eyes (4.7%). Other than one (1/725, 0.1%) safety related ICRS removal, 30/725 (4.1%) were due to visual symptoms. ICRS removal was accomplished under topical anesthesia without complications in all eyes. The mean length of time the segments remained in the cornea after initial surgery was 10.3 ± 5.4 months. At 3 months after ICRS removal, 21 eyes had monitored data available and were within ±1 line or 10 letters of their preoperative BSCVA. Twenty eyes (20/21, 95%) returned to within ±1.00 D of their preoperative manifest spherical equivalent refraction. All eyes had a stable refraction at the 3-month examination after removal, and a manifest spherical equivalent refraction within ±1.00 D of their 1-month examination after removal. Nineteen eyes (19/21, 90%) returned to within ±2 lines and 16 eyes (16/21, 76%) returned to within ±1 line of preoperative UCVA. CONCLUSION: The ICRS (Intacs) was easily and safely removed, and eyes returned to preoperative refractive status within 3 months.

Original languageEnglish (US)
Pages (from-to)25-31
Number of pages7
JournalJournal of Refractive Surgery
Volume17
Issue number1
StatePublished - 2001

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Visual Acuity
Phase III Clinical Trials
Phase II Clinical Trials
Cornea
Anesthesia
Safety

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Asbell, P. A., Uçakhan, Ö. Ö., Abbott, R. L., Assil, K. A., Burris, T. E., Durrie, D. S., ... Waring, G. O. (2001). Intrastromal corneal ring segments: Reversibility of refractive effect. Journal of Refractive Surgery, 17(1), 25-31.

Intrastromal corneal ring segments : Reversibility of refractive effect. / Asbell, P. A.; Uçakhan, Ö Ö; Abbott, R. L.; Assil, K. A.; Burris, T. E.; Durrie, D. S.; Lindstrom, R. L.; Schanzlin, D. J.; Verity, Steven; Waring, G. O.

In: Journal of Refractive Surgery, Vol. 17, No. 1, 2001, p. 25-31.

Research output: Contribution to journalArticle

Asbell, PA, Uçakhan, ÖÖ, Abbott, RL, Assil, KA, Burris, TE, Durrie, DS, Lindstrom, RL, Schanzlin, DJ, Verity, S & Waring, GO 2001, 'Intrastromal corneal ring segments: Reversibility of refractive effect', Journal of Refractive Surgery, vol. 17, no. 1, pp. 25-31.
Asbell PA, Uçakhan ÖÖ, Abbott RL, Assil KA, Burris TE, Durrie DS et al. Intrastromal corneal ring segments: Reversibility of refractive effect. Journal of Refractive Surgery. 2001;17(1):25-31.
Asbell, P. A. ; Uçakhan, Ö Ö ; Abbott, R. L. ; Assil, K. A. ; Burris, T. E. ; Durrie, D. S. ; Lindstrom, R. L. ; Schanzlin, D. J. ; Verity, Steven ; Waring, G. O. / Intrastromal corneal ring segments : Reversibility of refractive effect. In: Journal of Refractive Surgery. 2001 ; Vol. 17, No. 1. pp. 25-31.
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abstract = "PURPOSE: To evaluate the reversibility of refractive effect following removal of the ICRS (intrastromal corneal ring segments; Intacs). METHODS: Data from 34 eyes from which ICRS were removed during United States FDA Phase II and III clinical trials were evaluated with regard to segment size, loss or change of best spectacle-corrected visual acuity (BSCVA), any change of uncorrected visual acuity (UCVA), manifest spherical equivalent refraction, manifest cylinder refraction, stability of manifest cylinder refraction, and subjective visual symptoms. RESULTS: Out of 725 initial or contralateral eyes placed with the ICRS during Phase II and III clinical trials, segments were removed from 34 eyes (4.7{\%}). Other than one (1/725, 0.1{\%}) safety related ICRS removal, 30/725 (4.1{\%}) were due to visual symptoms. ICRS removal was accomplished under topical anesthesia without complications in all eyes. The mean length of time the segments remained in the cornea after initial surgery was 10.3 ± 5.4 months. At 3 months after ICRS removal, 21 eyes had monitored data available and were within ±1 line or 10 letters of their preoperative BSCVA. Twenty eyes (20/21, 95{\%}) returned to within ±1.00 D of their preoperative manifest spherical equivalent refraction. All eyes had a stable refraction at the 3-month examination after removal, and a manifest spherical equivalent refraction within ±1.00 D of their 1-month examination after removal. Nineteen eyes (19/21, 90{\%}) returned to within ±2 lines and 16 eyes (16/21, 76{\%}) returned to within ±1 line of preoperative UCVA. CONCLUSION: The ICRS (Intacs) was easily and safely removed, and eyes returned to preoperative refractive status within 3 months.",
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T2 - Reversibility of refractive effect

AU - Asbell, P. A.

AU - Uçakhan, Ö Ö

AU - Abbott, R. L.

AU - Assil, K. A.

AU - Burris, T. E.

AU - Durrie, D. S.

AU - Lindstrom, R. L.

AU - Schanzlin, D. J.

AU - Verity, Steven

AU - Waring, G. O.

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N2 - PURPOSE: To evaluate the reversibility of refractive effect following removal of the ICRS (intrastromal corneal ring segments; Intacs). METHODS: Data from 34 eyes from which ICRS were removed during United States FDA Phase II and III clinical trials were evaluated with regard to segment size, loss or change of best spectacle-corrected visual acuity (BSCVA), any change of uncorrected visual acuity (UCVA), manifest spherical equivalent refraction, manifest cylinder refraction, stability of manifest cylinder refraction, and subjective visual symptoms. RESULTS: Out of 725 initial or contralateral eyes placed with the ICRS during Phase II and III clinical trials, segments were removed from 34 eyes (4.7%). Other than one (1/725, 0.1%) safety related ICRS removal, 30/725 (4.1%) were due to visual symptoms. ICRS removal was accomplished under topical anesthesia without complications in all eyes. The mean length of time the segments remained in the cornea after initial surgery was 10.3 ± 5.4 months. At 3 months after ICRS removal, 21 eyes had monitored data available and were within ±1 line or 10 letters of their preoperative BSCVA. Twenty eyes (20/21, 95%) returned to within ±1.00 D of their preoperative manifest spherical equivalent refraction. All eyes had a stable refraction at the 3-month examination after removal, and a manifest spherical equivalent refraction within ±1.00 D of their 1-month examination after removal. Nineteen eyes (19/21, 90%) returned to within ±2 lines and 16 eyes (16/21, 76%) returned to within ±1 line of preoperative UCVA. CONCLUSION: The ICRS (Intacs) was easily and safely removed, and eyes returned to preoperative refractive status within 3 months.

AB - PURPOSE: To evaluate the reversibility of refractive effect following removal of the ICRS (intrastromal corneal ring segments; Intacs). METHODS: Data from 34 eyes from which ICRS were removed during United States FDA Phase II and III clinical trials were evaluated with regard to segment size, loss or change of best spectacle-corrected visual acuity (BSCVA), any change of uncorrected visual acuity (UCVA), manifest spherical equivalent refraction, manifest cylinder refraction, stability of manifest cylinder refraction, and subjective visual symptoms. RESULTS: Out of 725 initial or contralateral eyes placed with the ICRS during Phase II and III clinical trials, segments were removed from 34 eyes (4.7%). Other than one (1/725, 0.1%) safety related ICRS removal, 30/725 (4.1%) were due to visual symptoms. ICRS removal was accomplished under topical anesthesia without complications in all eyes. The mean length of time the segments remained in the cornea after initial surgery was 10.3 ± 5.4 months. At 3 months after ICRS removal, 21 eyes had monitored data available and were within ±1 line or 10 letters of their preoperative BSCVA. Twenty eyes (20/21, 95%) returned to within ±1.00 D of their preoperative manifest spherical equivalent refraction. All eyes had a stable refraction at the 3-month examination after removal, and a manifest spherical equivalent refraction within ±1.00 D of their 1-month examination after removal. Nineteen eyes (19/21, 90%) returned to within ±2 lines and 16 eyes (16/21, 76%) returned to within ±1 line of preoperative UCVA. CONCLUSION: The ICRS (Intacs) was easily and safely removed, and eyes returned to preoperative refractive status within 3 months.

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