Aberration analyses needed for FDA evaluation of safety and effectiveness of wavefront-guided refractive surgical devices

Journal of Refractive Surgery

Volumn 19, Issue 5, 2003, Pages

  Drum, Bruce A ^a,b  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b HFZ 460 ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABERROMETRY; ASTIGMATISM; CONFERENCE PAPER; CONTRAST SENSITIVITY; EYE SURGERY; FOOD AND DRUG ADMINISTRATION; HUMAN; KERATOMETRY; LASER SURGERY; MEDICAL TECHNOLOGY; OPTICAL BIOSENSOR; PRIORITY JOURNAL; QUESTIONNAIRE; REFRACTION ERROR; SAFETY; SENSOR; TREATMENT OUTCOME; VISUAL ACUITY; WAVEFRONT ABERRATION;

CORNEA; CORNEAL TOPOGRAPHY; DEVICE APPROVAL; HUMANS; KERATECTOMY, PHOTOREFRACTIVE, EXCIMER LASER; KERATOMILEUSIS, LASER IN SITU; REFRACTION, OCULAR; REFRACTIVE ERRORS; SAFETY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0141433495     PISSN: 1081597X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (5)

1. Code of Federal Regulations; 21 CFR 860.7; Washington, DC: U.S. Government Printing Office; 2002.
2. Federal Food, Drug and Cosmetic Act, as amended February, 1998; Washington, DC: U.S. Government Printing Office;1998.
3. Liang J, Grimm B, Goelz S, Bille JF. Objective measurement of wave aberrations of the human eye with the use of a Hartmann-Shock wave-front sensor. J Opt Soc Am A 1994;11:1949-1957.
4. Liang J, Williams DR, Miller DT. Supernormal vision and high-resolution retinal imaging through adaptive optics. J Opt Soc Am A 1997;14:1884-2992.
5. Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers. FDA guidance document, October 10, 1996, http://www.fda.gov/cdrh/ode/2093.pdf.