United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: Three-year follow-up

Ophthalmology

Volumn 111, Issue 9, 2004, Pages 1683-1692

[No Author Info available]

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CATARACT EXTRACTION; CELL LOSS; CLINICAL TRIAL; CONTRAST SENSITIVITY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORNEA ENDOTHELIUM; DEVICE REMOVAL; DIPLOPIA; DRIVING ABILITY; FEMALE; FOOD AND DRUG ADMINISTRATION; GLARE; HUMAN; IMPLANTABLE COLLAMER LENS; IMPLANTATION; LENS IMPLANT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYOPIA; NIGHT VISION; PATIENT SATISFACTION; POSTOPERATIVE COMPLICATION; POSTOPERATIVE PERIOD; PREDICTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; SAFETY; STATISTICAL SIGNIFICANCE; TREATMENT OUTCOME; UNITED STATES; VISUAL ACUITY; ANTERIOR EYE CHAMBER; CELL COUNT; CONTACT LENS; FOLLOW UP; MIDDLE AGED; PATHOLOGY; PATHOPHYSIOLOGY; PHYSIOLOGY; PROSTHESIS;

ADULT; ANTERIOR CHAMBER; CELL COUNT; CONTACT LENSES; CONTRAST SENSITIVITY; ENDOTHELIUM, CORNEAL; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; MYOPIA; PATIENT SATISFACTION; POSTOPERATIVE COMPLICATIONS; PROSPECTIVE STUDIES; PROSTHESIS DESIGN; PROSTHESIS IMPLANTATION; SAFETY; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VISUAL ACUITY;

EID: 4444238096     PISSN: 01616420     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ophtha.2004.03.026     Document Type: Article

References (33)

1. Implantable Contact Lens in Treatment of Myopia (ITM) Study Group. U.S. Food and Drug Administration clinical trial of the Implantable Contact Lens for moderate to high myopia. Ophthalmology. 110:2003;255-266
2. Arne J.L., Lesueur L.C. Phakic posterior chamber lenses for high myopia functional and anatomical outcomes. J Cataract Refract Surg. 26:2000;369-374
3. Gonvers M., Othenin-Girard P., Barnet C., Sickenberg M. Implantable contact lens for moderate to high myopia short-term follow-up of 2 models. J Cataract Refract Surg. 27:2001;380-388
4. Menezo J.L., Peris-Martinez C., Cisneros A., Martinez-Costa R. Posterior chamber phakic intraocular lenses to correct high myopia a comparative study between STAAR and Adatomed models. J Refract Surg. 17:2001;32-42
5. Pesando P.M., Ghiringhello M.P., Tagliavacche P. Posterior chamber collamer phakic intraocular lens for myopia and hyperopia. J Refract Surg. 15:1999;415-423
6. Assetto V., Benedetti S., Pesando P. Collamer intraocular contact lens to correct high myopia. J Cataract Refract Surg. 22:1996;551-556
7. Zaldivar R., Davidorf J.M., Oscherow S. Posterior chamber phakic intraocular lens for myopia of -8 to -19 diopters. J Refract Surg. 14:1998;294-305
8. BenEzra D., Cohen E., Karshai I. Phakic posterior chamber intraocular lens for the correction of anisometropia and treatment of amblyopia. Am J Ophthalmol. 130:2000;292-296
9. Fink A.M., Gore C., Rosen E. Cataract development after implantation of the Staar Collamer posterior chamber phakic lens. J Cataract Refract Surg. 25:1999;278-282
10. Jimenez-Alfaro I., Benitez del Castillo J.M., Garcia-Feijoo J., et al. Safety of posterior chamber phakic intraocular lenses for the correction of high myopia anterior segment changes after posterior chamber phakic intraocular lens implantation. Ophthalmology. 108:2001;90-99
11. Kaya V., Kevser M.A., Yilmaz O.F. Phakic posterior chamber plate intraocular lenses for high myopia. J Refract Surg. 15:1999;580-585
12. Rosen E., Gore C. Staar Collamer posterior chamber phakic intraocular lens to correct myopia and hyperopia. J Cataract Refract Surg. 24:1998;596-606
13. Longitudinal Study of Cataract Study Group, Chylack L.T. Jr, Wolfe J.K., Singer D.M., et al. The Lens Opacities Classification System III. Arch Ophthalmol. 111:1993;831-836
14. Edelhauser H.F., Sanders D.R., Azar R., et al. Corneal endothelial assessment after ICL implantation. J Cataract Refract Surg. 30:2004;576-583
15. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Guidance for industry and FDA staff: expedited review of premarket submissions for devices. Available at: http://www.fda.gov/cdrh/mdufma/guidance/ 108.html. Accessed March 18, 2004
16. Abu El-Asrar A.M., Al-Bishi S.M., Kangave D. Outcome of temporary silicone oil tamponade in complex rhegmatogenous retinal detachment. Eur J Ophthalmol. 13:2003;474-481
17. Scott I.U., Flynn H.W. Jr, Azen S.P., et al. Silicone oil in the repair of pediatric complex retinal detachments a prospective, observational, multicenter study. Ophthalmology. 106:1999;1399-1407
18. Barbados Eye Studies Group, Leske M.C., Wu S.Y., Nemesure B., Hennis A. Risk factors for incident nuclear opacities. Ophthalmology. 109:2002;1303-1308
19. Wong T.Y., Klein B.E., Klein R., et al. Refractive errors and incident cataracts the Beaver Dam Eye Study. Invest Ophthalmol Vis Sci. 42:2001;1449-1454
20. Younan C., Mitchell P., Cumming R.G., et al. Myopia and incident cataract surgery the Blue Mountain Eye Study. Invest Ophthalmol Vis Sci. 43:2002;3625-3632
21. Leske M.C., Chylack L.T. Jr, Wu S.Y. The Lens Opacities Case-Control Study. Risk factor for cataract. Arch Ophthalmol. 109:1991;244-251
22. Perkins E.S. Morbidity from myopia. Sight Sav Rev. 49:1979;11-19
23. Sanders D.R., Vukich J.A. Comparison of Implantable Contact Lens and laser assisted in situ keratomileusis for moderate to high myopia. Cornea. 22:2003;324-331
24. TM) and laser assisted in situ keratomileusis (LASIK) in low myopia. Cornea. In press
25. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Premarket Approval Application (PMA) summary of safety and effectiveness data (PMA P970053/S002). Nidek EC-5000 excimer laser system. Rockville, MD: Center for Devices and Radiological Health; 2000. Available at: http://www.fda.gov/cdrh/pdf/p970053s002.html. Accessed November 1, 2003
26. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Premarket Approval Application (PMA) summary of safety and effectiveness data (PMA P970043/S005). LADARVision excimer laser system. Rockville, MD: Center for Devices and Radiological Health; 2000. Available at: http://www.fda.gov/cdrh/pdf/p970043s002.html. Accessed November 1, 2003
27. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Premarket Approval Application (PMA) summary of safety and effectiveness data (PMA P930034/S013). SVS Apex Plus excimer laser workstation, emphasis "M" discs. Rockville, MD. Center for Devices and Radiological Health; 1999. Available at: http://www.fda.gov/cdrh/pdf/p930034s013.html. Accessed November 1, 2003
28. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Premarket Approval Application (PMA) summary of safety and effectiveness data (PMA P970005). Kremer excimer laser system serial no. KEA940202 for laser in situ keratomileusis (LASIK) for the correction of primary myopia with and without astigmatism. Rockville, MD: Center for Devices and Radiological Health; 1999. Available at: http://www.fda.gov/cdrh/pdf/p970005.html. Accessed November 1, 2003
29. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Premarket Approval Application (PMA) summary of safety and effectiveness data (PMA P990027). Technolas 217A excimer laser system. Rockville, MD: Center for Devices and Radiological Health; 2000. Available at: http://www.fda.gov/ cdrh/pdf/p990027.html. Accessed November 1, 2003
30. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Premarket Approval Application (PMA) summary of safety and effectiveness data (PMA P990010). Visx STAR S2 excimer laser system. Rockville, MD: Center for Devices and Radiological Health; 1999. Available at: http://www.fda.gov/ cdrh/pdf/p990010.html. Accessed November 1, 2003
31. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Premarket Approval Application (PMA) summary of safety and effectiveness data (PMA P970049). Dishler excimer laser system. Rockville, MD: Center for Devices and Radiological Health; 1999. Available at: http://www.fda.gov/cdrh/ pdf/p970049.html. Accessed November 1, 2003
32. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Premarket Approval Application (PMA) summary of safety and effectiveness data (PMA P970043/S010). Alcon Laboratories, Inc. LADARVision 4000 excimer laser system. Rockville, MD: Center for Devices and Radiological Health; 2002. Available at: http://www.fda.gov/cdrh/pdf/p970043s010.html. Accessed November 1, 2003
33. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Premarket Approval Application (PMA) summary of safety and effectiveness data (PMA P980008/S005). LaserSight LaserScan LSX excimer laser system. Rockville, MD: Center for Devices and Radiological Health; 2001. Available at: http://www.fda.gov/cdrh/pdf/p980008s005.html. Accessed November 1, 2003