The DOI matches its Crossref record.
Four-year Postoperative Results of the US ALLEGRETTO WAVE Clinical Trial for the Treatment of Hyperopia
Abstract
Purpose To evaluate the long-term refractive stability after LASIK for hyperopia with the WaveLight ALLEGRETTO WAVE Excimer Laser System. Methods All 151 patients enrolled in the 2000-2002 FDA study of the ALLEGRETTO WAVE laser were contacted by the investigators approximately 4 years after study completion to be evaluated for refractive stability. Results A total of 127/290 (43.8%) eyes in 68/151 (45%) patients presented for re-examination. Mean time from the examination taken at the 6-month follow-up stability endpoint in the FDA trial (Stability Exam) to the Post-Approval Exam was 3.9+/-0.39 years (range: 3.2 to 4.9 years). Stability of the manifest refraction spherical equivalent (MRSE) within +/-1.00 D or less was seen in 119/127 (93.7%) eyes. Regression of effect of >1.00 D was seen in 6/127 (4.7%) eyes and progression of effect was seen in 2/127 (1.6%) eyes. Weak correlation of refractive changes with keratometry readings were seen in eyes that underwent >2.00 to 4.00 D treatment (R=0.31) and >4.00 D treatment (R=0.33), implying corneal remodeling may have played a role in the refractive change observed. Conclusions Refractive stability within +/-1.00 D MRSE after hyperopic LASIK with the ALLEGRETTO WAVE excimer laser was seen in 93.7% of eyes at > or =3 years after surgery compared with 6-month follow-up, supporting the conclusion in the FDA trial that refractive stability occurred by 6 months postoperatively. Refractive changes associated with keratometry changes wer…
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“This is because epithelial hyperplasia, the major cause of regression, occurs mostly during the first 6 months post-LASIK.5,6”
From Treatment of moderate-to-high hyperopia with the WaveLight Allegretto 400 and EX500 excimer laser systems (2017) · cites this paper as [5]
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Research works printed but not linked: 9
- 10.3928/1081-597X-20050101-11 · DOI
- 10.1016/j.ophtha.2004.09.017 · DOI
- 10.3928/1081-597X-20040701-09 · DOI
- 10.3928/1081-597X-19980401-07 · DOI
- 10.1016/S0161-6420(00)00097-X · DOI
- 10.3928/1081-597X-20060101-10 · DOI
- 10.1016/S0002-9394(02)01942-6 · DOI
- 10.1016/S0886-3350(03)00415-2 · DOI
- 10.1016/j.jcrs.2004.10.051 · DOI
Cited by
LASIK and PRK in hyperopic astigmatic eyes: is early retreatment advisable?
Frings, A., Richard, G., Steinberg, J., Linke, S., Katz, T., & Druchkiv, V. (2016) · Clinical Ophthalmology · doi:10.2147/opth.s99098 · Cited by 29
Motwani, M., & Pei, R. (2017) · Clinical Ophthalmology · doi:10.2147/opth.s136061 · Cited by 19
Metadata
- Authors
- Kezirian, G. M., Moore, C. R., Stonecipher, K. G., & SurgiVision® Consultants Inc WaveLight Investigator Group
- ORCID
- Stonecipher, Karl G.
- Venue
- Journal of Refractive Surgery
- Publisher
- SLACK, Inc.
- Published
- 2008-04
- Volume
- 24
- Issue
- S2
- Pages
- S431-8
- ISSN
- 1042-962X (ISSN-L)
- 1081-597X
- OpenAlex
- W2276700986
- Cited by
- 24
- References
- 0
- Citations by year
- 2025: 3 · 2024: 2 · 2022: 1 · 2021: 2 · 2020: 1 · 2018: 2 · 2017: 2 · 2016: 1 · 2014: 1 · 2013: 2 · 2012: 1
- FWCI
- 1.54
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Refractive Surgery (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Ophthalmology › Corneal surgery and disorders
- Health Sciences › Medicine › Ophthalmology › Ophthalmology and Visual Impairment Studies
- Physical Sciences › Physics and Astronomy › Atomic and Molecular Physics, and Optics › Adaptive optics and wavefront sensing
- Keywords
- hyperopia, hyperopic LASIK, refractive stability, refractive regression, refractive changes, keratometry, corneal remodeling, long-term outcomes, spherical equivalent
- MeSH terms
- Adult, Aged, Female, Humans, Hyperopia, Male, Middle Aged, United States, United States Food and Drug Administration, Visual Acuity, Treatment Outcome, Corneal Topography, Keratomileusis, Laser In Situ, Lasers, Excimer
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