U.S. food and drug administration clinical trial of the implantable contact lens for moderate to high myopia

Ophthalmology

Volumn 110, Issue 2, 2003, Pages 255-266

  Vukich, John A ^a   Duehr, Davis ^a   Sanders, Donald R ^b   Doney, Kimberley ^b   Barnett, Ronald ^c   Dulaney, David ^c   Perkins, Scott ^c   Rowen, Sheri L ^d   Steel, Douglas ^e   Berkeley, Ralph ^f   Caplan, Michael ^f   Mann, Paul ^f   Bylsma, Stephen ^g   Martin, R Gale ^h   Brown, David C ⁱ   Grabow, Harry ^j   Williamson, Charles H ^k   Shepherd, John R ^l   Fine, Howard ^m   Kraff, Manus ⁿ   Fabricant, Robert ^o   Berg, Alan ^p   Gaston, Monica ^q   Hall, Nancy ^q   Smith, Darcy ^q   more..

^a DEAN MEDICAL CENTER   (United States)

^b Center for Clinical Research   (United States)

^c Barnet Dulaney Perkins Eye Center   (United States)

^d Rowen Laser Vision/Correction Ctr   (United States)

^e Advance Sight Medical Group   (United States)

^f Houston Microsurgery Center   (United States)

^g Shepard Eye Center   (United States)

^h Carolina Eye Associates   (United States)

ⁱ Eye Centers of Florida   (United States)

^j Sarasota Cataract Institute   (United States)

^k Williamson Eye Center   (United States)

^l Shepherd Eye Center   (United States)

^m Oregon Cardiology PC   (United States)

ⁿ Kraff Eye Institute   (United States)

^o Pacific Eye Institute   (United States)

^p Advanced Vision Correction Centers   (United States)

^q STAAR Surgical Company   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOPLEGIC AGENT; DEXAMETHASONE PLUS TOBRAMYCIN; OFLOXACIN; PRESERVATIVE;

ADULT; ANTERIOR EYE CHAMBER; ARTICLE; CATARACT; CATARACT EXTRACTION; CLINICAL TRIAL; CONTACT LENS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIPLOPIA; DRIVING ABILITY; EYE REFRACTION; FEMALE; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GLARE; HUMAN; LENS IMPLANT; LENS POWER; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYOPIA; PATIENT SATISFACTION; PEROPERATIVE COMPLICATION; PHASE 1 CLINICAL TRIAL; POSTOPERATIVE COMPLICATION; PREDICTION; PRIORITY JOURNAL; QUESTIONNAIRE; REFRACTION ERROR; SAFETY; SPECTACLES; SYMPTOM; TREATMENT INDICATION; TREATMENT OUTCOME; VISION; VISUAL ACUITY;

EID: 0037312362     PISSN: 01616420     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0161-6420(02)01771-2     Document Type: Article

References (42)

1. Kim JH, Hahn TW, Lee YC, Sah WJ. Excimer laser photorefractive keratectomy for myopia: two year follow-up. J Cataract Refract Surg 1994;20(Suppl):S229-33.
2. Maguen E, Salz JJ, Nesburn AB, et al. Results of excimer laser photorefractive keratectomy for the correction of myopia. Ophthalmology 1994;101:1548-56 discussion 1556-7.
3. Pietilä J, Mäkinen P, Pajari S, et al. Photorefractive keratectomy for -1.25 to -25.00 diopters of myopia. J Refract Surg 1998;14:615-22.
4. Heitzmann J, Binder PS, Kassar BS, Nordan LT. The correction of high myopia using the excimer laser. Arch Ophthalmol 1993;111:1627-34.
5. Seiler T, Holschbach A, Derse M, et al. Complications of myopic photorefractive keratectomy with the excimer laser. Ophthalmology 1994;101:153-60.
6. Hersh PS, Steinert RF, Brint SF. Photorefractive keratectomy versus laser in situ keratomileusis: comparison of optical side effects. Summit PRK-LASIK Study Group. Ophthalmology 2000;107:925-33.
7. Holladay JT, Dudeja DR, Chang J. Functional vision and corneal changes after laser in situ keratomileusis determined by contrast sensitivity, glare testing, and corneal topography. J Cataract Refract Surg 1999;25:663-9.
8. Joo CK, Kim TG. Corneal perforation during laser in situ keratomileusis. J Cataract Refract Surg 1999;25:1165-7.
9. Goes FJ. Photorefractive keratectomy for myopia of -8.00 to -24.00 diopters. J Refract Surg 1996;12:91-7.
10. Davidorf JM, Zaldivar R, Oscherow S. Results and complications of laser in situ keratomileusis by experienced surgeons. J Refract Surg 1998;14:114-22.
11. Holland SP, Srivannaboon S, Reinstein DZ. Avoiding serious corneal complications of laser assisted in situ keratomileusis and photorefractive keratectomy. Ophthalmology 2000;107:640-52.
12. Geggel HS, Talley AR. Delayed onset keratectasia following laser in situ keratomileusis. J Cataract Refract Surg 1999;25:582-6.
13. Tsai RJ. Laser in situ keratomileusis for myopia of -2 to -25 diopters. J Refract Surg 1997;13:S427-9.
14. Knorz MC, Liermann A, Seiberth V, et al. Laser in situ keratomileusis to correct myopia of -6.00 to -29.00 diopters. J Refract Surg 1996;12:575-84.
15. Shah MN, Misra M, Wihelmus KR, Koch DD. Diffuse lamellar keratitis associated with epithelial defects after laser in situ keratomileusis. J Cataract Refract Surg 2000;26:1312-8.
16. Baikoff G, Ame JL, Bokobza Y, et al. Angle-fixated anterior chamber phakic intraocular lens for myopia of -7 to -19 diopters. J Refract Surg 1998;14:282-93.
17. Fyodorov SN, Zuev VK, Tumanyan ER, et al. Analysis of long term clinical and functional results of intraocular correction of high myopia. Ophthalmosurgery (Moscow) 1990;2:3-6.
18. Menezo JL, Cisneros A, Hueso JR, Harto M. Long-term results of surgical treatment of high myopia with Worst-Fechner intraocular lenses. J Cataract Refract Surg 1995;21:93-8.
19. Sanders DR, Brown DC, Martin RG, et al. Implantable contact lens for moderate to high myopia: phase I FDA clinical study with 6 month follow-up. J Cataract Refract Surg 1998;24:607-11.
20. Ame JL, Lesueur LC. Phakic posterior chamber lenses for high myopia: functional and anatomical outcomes. J Cataract Refract Surg 2000;26:369-74.
21. Gonvers M, Othenin-Girard P, Bomet C, Sickenberg M. Implantable contact lens for moderate to high myopia: short-term follow-up of 2 models. J Cataract Refract Surg 2001;27:380-8.
22. Menezo JL, Peris-Martínez C, Cisneros A, Martínez-Costa R. Posterior chamber phakic intraocular lenses to correct high myopia: a comparative study between Staar and Adatomed models. J Refract Surg 2001;17:32-42.
23. Pesando PM, Ghiringhello MP, Tagliavacche P. Posterior chamber collamer phakic intraocular lens for myopia and hyperopia. J Refract Surg 1999;15:415-23.
24. Assetto V, Benedetti S, Pesando P. Collamer intraocular contact lens to correct high myopia. J Cataract Refract Surg 1996;22:551-6.
25. Zaldivar R, Davidorf JM, Oscherow S. Posterior chamber phakic intraocular lens for myopia of -8 to -19 diopters. J Refract Surg 1998;14:294-305.
26. BenEzra D, Cohen E, Karshai I. Phakic posterior chamber intraocular lens for the correction of anisometropia and treatment of amblyopia. Am J Ophthalmol 2000;130:292-6.
27. Jimenez-Alfaro I, Benitez del Castillo JM, 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 2001;108:90-9.
28. Kaya V, Kevser MA, Yilmaz OF. Phakic posterior chamber plate intraocular lenses for high myopia. J Refract Surg 1999;15:580-5.
29. Rosen E, Gore C. Staar Collamer posterior chamber phakic intraocular lens to correct myopia and hyperopia. J Cataract Refract Surg 1998;24:596-606.
30. Sánchez-Galeana CA, Smith RJ, Rodriguez X, et al. Laser in situ keratomileusis and photorefractive keratectomy for residual refractive error after phakic intraocular lens implantation. J Refract Surg 2001;17:299-304.
31. Chylack LT Jr, Wolfe JK, Singer DM, et al. The Lens Opacities Classification System III. The Longitudinal Study Of Cataract Study Group. Arch Ophthalmol 1993;111:831-6.
32. Trindade F, Pereira F. Cataract formation after posterior chamber phakic intraocular lens implantation. J Cataract Refract Surg 1999;24:1661-3.
33. Autonomous Technologies Corporation. LADAR Vision Excimer Laser System-P970043. Summary of Safety and Effectiveness Data. Rockville, MD: Center for Devices and Radiological Health, 1998.
34. LaserSight Technologies, Inc.. Summary of Safety and Effectiveness Data. LaserScan LSX Excimer Laser System for photorefractive keratectomy for myopia-P980008. Rockville, MD: Center for Devices and Radiological Health, 1999.
35. Nidek Technologies Inc. Nidek EC-5000 Excimer Laser System-P970053. Summary of Safety and Effectiveness Data. Rockville, MD: Centers for Devices and Radiological Health, 1998.
36. Nidek Technologies, Inc. Nidek EC-5000 Excimer Laser System for Photorefractive Keratectomy for Moderate Myopia with Asgigmatism-P970053/5001. Summary of Safety and Effectiveness Data for a Supplemental Premarket Approval (PMA) Application. Rockville, MD: Center for Devices and Radiological Health, 2000.
37. Autonomous Technologies Corporation. LADARVision Excimer Laser System-P970043/S005. Summary of Safety and Effectiveness Data for a Supplemental Premarket Approval Application (PMA) Application. Rockville, MD: Center for Devices and Radiological Health, 2000.
38. Dishler JG, Dishler Excimer Laser System-P970049. Summary of Safety and Effectiveness Data. Rockville MD: Center for Devices and Radiological Health, 1999.
39. Photomed, Inc. Kremer Excimer Laser System Serial No. KEA940202 for Laser In Situ Keratomileusis (LASIK) for the Correction of Primary Myopia, with and Without Astigmatism-P970005. Summary of Safety and Effectiveness Data. Rockville, MD: Center for Devices and Radiological Health, 1999.
40. Summit Technology, Inc. SVS Apex Plus Excimer Laser Workstation emphasis M "discs"-P930034/S013. Summary of Safety and Effectiveness Data for a Supplemental Premarket Approval Application. Rockville, MD: Center for Devices and Radiological Health, 1999.
41. Fink AM, Gore C, Rosen E. Cataract development after implantation of the Staar Collamer posterior chamber phakic lens. J Cataract Refract Surg 1999;25:278-82.
42. CRS Clinical Research, Inc. VISX STAR S2 Excimer Laser System-P990010. Summary of Safety and Effectiveness Data. Rockville, MD: Center for Devices and Radiological Health, 1999.