NCT00000129

Brief Summary

To determine whether radial keratotomy is effective in reducing myopia. To detect complications of the surgery. To discover patient characteristics and surgical factors affecting the results. To determine the long-term safety and efficacy of the procedure.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 1981

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1981

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1983

Completed
16 years until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
Last Updated

September 17, 2009

Status Verified

September 1, 2009

First QC Date

September 23, 1999

Last Update Submit

September 16, 2009

Conditions

Myopia

Interventions

Radial KeratotomyPROCEDURE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
All men and women had 2 to 8 diopters of simple myopia and were correctable to 20/20 or better with glasses or contact lenses. All patients had the stability of their myopia documented by previous records. Patients were at least 21 years of age and lived in the metropolitan area of the study centers. Each patient agreed to have surgery on one eye and to wait 1 year for surgery on the other eye. Patients with systemic diseases that might affect corneal wound healing and patients with high corneal astigmatism were excluded from the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (37)

  • Waring GO 3rd, Moffitt SD, Gelender H, Laibson PR, Lindstrom RL, Myers WD, Obstbaum SA, Rowsey JJ, Safir A, Schanzlin DJ, Bourque LB. Rationale for and design of the National Eye Institute Prospective Evaluation of Radial Keratotomy (PERK) Study. Ophthalmology. 1983 Jan;90(1):40-58. doi: 10.1016/s0161-6420(83)34603-0.

    PMID: 6338438BACKGROUND

  • Bourque LB, Rubenstein R, Cosand B, Waring GO 3rd, Moffitt S, Gelender H, Laibson PR, Lindstrom RL, McDonald M, Myers WD, et al. Psychosocial characteristics of candidates for the prospective evaluation of radial keratotomy (PERK) study. Arch Ophthalmol. 1984 Aug;102(8):1187-92. doi: 10.1001/archopht.1984.01040030965027.

    PMID: 6380467BACKGROUND

  • Novak AF; Lindstrom RL; Williams PA; Everson M; Corneal pachymetry prior to radial keratotomy: a comparison of techniques., J Refract Surg 1985;1:151-153

    BACKGROUND

  • Steinberg EB, Waring GO 3rd. Comparison of two methods of marking the visual axis on the cornea during radial keratotomy. Am J Ophthalmol. 1983 Nov;96(5):605-8. doi: 10.1016/s0002-9394(14)73417-8.

    PMID: 6638126BACKGROUND

  • Steinberg EB, Wilson LA, Waring GO 3rd, Lynn MJ, Coles WH. Stellate iron lines in the corneal epithelium after radial keratotomy. Am J Ophthalmol. 1984 Oct 15;98(4):416-21. doi: 10.1016/0002-9394(84)90122-3.

    PMID: 6486212BACKGROUND

  • Nelson JD, Williams P, Lindstrom RL, Doughman DJ. Map-fingerprint-dot changes in the corneal epithelial basement membrane following radial keratotomy. Ophthalmology. 1985 Feb;92(2):199-205. doi: 10.1016/s0161-6420(85)34055-1.

    PMID: 3872431BACKGROUND

  • Waring GO 3rd, Lynn MJ, Gelender H, Laibson PR, Lindstrom RL, Myers WD, Obstbaum SA, Rowsey JJ, McDonald MB, Schanzlin DJ, et al. Results of the prospective evaluation of radial keratotomy (PERK) study one year after surgery. Ophthalmology. 1985 Feb;92(2):177-98, 307. doi: 10.1016/s0161-6420(85)34054-x.

    PMID: 3885128BACKGROUND

  • Atkin A, Asbell P, Justin N, Smith H, Wayne R, Winterkorn J. Radial keratotomy and glare effects on contrast sensitivity. Doc Ophthalmol. 1986 Feb 28;62(2):129-48. doi: 10.1007/BF00229125.

    PMID: 3956364BACKGROUND

  • Bourque LB, Cosand BB, Drews C, Waring GO 3rd, Lynn M, Cartwright C. Reported satisfaction, fluctuation of vision, and glare among patients one year after surgery in the Prospective Evaluation of Radial Keratotomy (PERK) Study. Arch Ophthalmol. 1986 Mar;104(3):356-63. doi: 10.1001/archopht.1986.01050150056026.

    PMID: 3954634BACKGROUND

  • Bourque LB; Cosand BB; Drews C; Waring GO; Lynn M; Cartwright C; Satisfaccion informada, fluctuacion de la vision y resplandor en pacientes al cabo de un ano tras la cirugia en el estudio de la evaluacion prospectiva de la queratotomia radial (EPQR)., Arch Ophthalmol 1986;2:57-64

    BACKGROUND

  • Mandelbaum S, Waring GO 3rd, Forster RK, Culbertson WW, Rowsey JJ, Espinal ME. Late development of ulcerative keratitis in radial keratotomy scars. Arch Ophthalmol. 1986 Aug;104(8):1156-60. doi: 10.1001/archopht.1986.01050200062050.

    PMID: 3741245BACKGROUND

  • Schanzlin DJ, Santos VR, Waring GO 3rd, Lynn M, Bourque L, Cantillo N, Edwards MA, Justin N, Reinig J, Roszka-Duggan V. Diurnal change in refraction, corneal curvature, visual acuity, and intraocular pressure after radial keratotomy in the PERK Study. Ophthalmology. 1986 Feb;93(2):167-75. doi: 10.1016/s0161-6420(86)33765-5.

    PMID: 3951823BACKGROUND

  • Villasenor RA, Santos VR, Cox KC, Harris DF 2nd, Lynn M, Waring GO 3rd. Comparison of ultrasonic corneal thickness measurements before and during surgery in the prospective evaluation of Radial Keratotomy (PERK) Study. Ophthalmology. 1986 Mar;93(3):327-30. doi: 10.1016/s0161-6420(86)33746-1.

    PMID: 3517739BACKGROUND

  • Lynn MJ; Waring GO; Predictability and stability of radial keratotomy., J. Refract Surg 1987;3:193-196

    BACKGROUND

  • Lynn MJ, Waring GO 3rd, Sperduto RD. Factors affecting outcome and predictability of radial keratotomy in the PERK Study. Arch Ophthalmol. 1987 Jan;105(1):42-51. doi: 10.1001/archopht.1987.01060010048030.

    PMID: 3800746BACKGROUND

  • Santos VR, Waring GO 3rd, Lynn MJ, Holladay JT, Sperduto RD. Relationship between refractive error and visual acuity in the Prospective Evaluation of Radial Keratotomy (PERK) Study. Arch Ophthalmol. 1987 Jan;105(1):86-92. doi: 10.1001/archopht.1987.01060010092038.

    PMID: 3800751BACKGROUND

  • Waring GO 3rd, Lynn MJ, Culbertson W, Laibson PR, Lindstrom RD, McDonald MB, Myers WD, Obstbaum SA, Rowsey JJ, Schanzlin DJ. Three-year results of the Prospective Evaluation of Radial Keratotomy (PERK) Study. Ophthalmology. 1987 Oct;94(10):1339-54. doi: 10.1016/s0161-6420(87)80021-0.

    PMID: 3684210BACKGROUND

  • Cartwright CS, Bourque LB, Lynn M, Waring GO 3rd. Relationship of glare to uncorrected visual acuity and cycloplegic refraction 1 year after radial keratotomy in the prospective evaluation of radial keratotomy (PERK) study. J Am Optom Assoc. 1988 Jan;59(1):36-9.

    PMID: 3278044BACKGROUND

  • McDonnell PJ, Schanzlin DJ. Early changes in refractive error following radial keratotomy. Arch Ophthalmol. 1988 Feb;106(2):212-4. doi: 10.1001/archopht.1988.01060130222031.

    PMID: 3341977BACKGROUND

  • Rowsey JJ, Balyeat HD, Monlux R, Holladay J, Waring GO 3rd, Lynn MJ. Prospective evaluation of radial keratotomy. Photokeratoscope corneal topography. Ophthalmology. 1988 Mar;95(3):322-34. doi: 10.1016/s0161-6420(88)33179-9.

    PMID: 3174000BACKGROUND

  • Santos VR, Waring GO 3rd, Lynn MJ, Schanzlin DJ, Cantillo N, Espinal ME, Garbus J, Justin N, Roszka-Duggan V. Morning-to-evening change in refraction, corneal curvature, and visual acuity 2 to 4 years after radial keratotomy in the PERK Study. Ophthalmology. 1988 Nov;95(11):1487-93. doi: 10.1016/s0161-6420(88)32981-7.

    PMID: 3211457BACKGROUND

  • Serle JB, Asbell PA, Obstbaum SA, Podos SM, Anh-Le N. The evaluation of corneal endothelial permeability in PERK study patients. Br J Ophthalmol. 1988 Apr;72(4):274-7. doi: 10.1136/bjo.72.4.274.

    PMID: 3378023BACKGROUND

  • Lynn MJ, Waring GO 3rd, Nizam A, Kutner MH, Culbertson W, McDonald MB, Meyers WD, Naidoff MA, Nelson JD, Obstbaum SA, et al. Symmetry of refractive and visual acuity outcome in the Prospective Evaluation of Radial Keratotomy (PERK) study. Refract Corneal Surg. 1989 Mar-Apr;5(2):75-81.

    PMID: 2488790BACKGROUND

  • Rowsey JJ, Monlux R, Balyeat HD, Stevens SX, Gelender H, Holladay J, Krachmer JH, Laibson P, Lindstrom R, Lynn M, et al. Accuracy and reproducibility of KeraScanner analysis in PERK corneal topography. PERK Study Group. Curr Eye Res. 1989 Jul;8(7):661-74. doi: 10.3109/02713688909025800.

    PMID: 2791617BACKGROUND

  • Ginsburg AP, Waring GO 3rd, Steinberg EB, Williams PA, Justin N, Deitz JR, Roszka-Duggan VK, Baluvelt K, Bourque L. Contrast sensitivity under photopic conditions in the Prospective Evaluation of Radial Keratotomy (PERK) Study. Refract Corneal Surg. 1990 Mar-Apr;6(2):82-91.

    PMID: 2248920BACKGROUND

  • Lynn MJ, Waring GO 3rd, Carter JT. Combining refractive error and uncorrected visual acuity to assess the effectiveness of refractive corneal surgery. Refract Corneal Surg. 1990 Mar-Apr;6(2):103-9; discussion 109-12.

    PMID: 2248912BACKGROUND

  • Waring GO 3rd, Lynn MJ, Fielding B, Asbell PA, Balyeat HD, Cohen EA, Culbertson W, Doughman DJ, Fecko P, McDonald MB, et al. Results of the Prospective Evaluation of Radial Keratotomy (PERK) Study 4 years after surgery for myopia. Perk Study Group. JAMA. 1990 Feb 23;263(8):1083-91.

    PMID: 2405203BACKGROUND

  • Holladay JT, Lynn MJ, Waring GO 3rd, Gemmill M, Keehn GC, Fielding B. The relationship of visual acuity, refractive error, and pupil size after radial keratotomy. Arch Ophthalmol. 1991 Jan;109(1):70-6. doi: 10.1001/archopht.1991.01080010072036.

    PMID: 1987953BACKGROUND

  • Rowsey JJ, Waring GO 3rd, Monlux RD, Balyeat HD, Stevens SX, Culbertson W, Barron B, Nelson D, Asbell P, Smith R, et al. Corneal topography as a predictor of refractive change in the prospective evaluation of radial keratotomy (PERK) study. Ophthalmic Surg. 1991 Jul;22(7):370-80.

    PMID: 1891181BACKGROUND

  • Waring GO 3rd, Lynn MJ, Nizam A, Kutner MH, Cowden JW, Culbertson W, Laibson PR, McDonald MB, Nelson JD, Obstbaum SA, et al. Results of the Prospective Evaluation of Radial Keratotomy (PERK) Study five years after surgery. The Perk Study Group. Ophthalmology. 1991 Aug;98(8):1164-76. doi: 10.1016/s0161-6420(91)32156-0.

    PMID: 1923352BACKGROUND

  • Waring GO 3rd, Lynn MJ, Strahlman ER, Kutner MH, Culbertson W, Laibson PR, Linstrom RD, McDonald MB, Myers WD, Obstbaum SA, et al. Stability of refraction during four years after radial keratotomy in the prospective evaluation of radial keratotomy study. Am J Ophthalmol. 1991 Feb 15;111(2):133-44. doi: 10.1016/s0002-9394(14)72250-0.

    PMID: 1801760BACKGROUND

  • Nizam A, Waring GO 3rd, Lynn MJ, Ward MA, Asbell PA, Balyeat HD, Cohen E, Culbertson W, Doughman DJ, Fecko P, et al. Stability of refraction and visual acuity during 5 years in eyes with simple myopia. The PERK Study Group. Refract Corneal Surg. 1992 Nov-Dec;8(6):439-47.

    PMID: 1493117BACKGROUND

  • Bourque LB, Lynn MJ, Waring GO 3rd, Cartwright C. Spectacle and contact lens wearing six years after radial keratotomy in the Prospective Evaluation of Radial Keratotomy Study. Ophthalmology. 1994 Mar;101(3):421-31. doi: 10.1016/s0161-6420(94)31315-7.

    PMID: 8127562BACKGROUND

  • Waring GO 3rd, Lynn MJ, McDonnell PJ. Results of the prospective evaluation of radial keratotomy (PERK) study 10 years after surgery. Arch Ophthalmol. 1994 Oct;112(10):1298-308. doi: 10.1001/archopht.1994.01090220048022.

    PMID: 7945032BACKGROUND

  • McDonnell PJ, Nizam A, Lynn MJ, Waring GO 3rd. Morning-to-evening change in refraction, corneal curvature, and visual acuity 11 years after radial keratotomy in the prospective evaluation of radial keratotomy study. The PERK Study Group. Ophthalmology. 1996 Feb;103(2):233-9. doi: 10.1016/s0161-6420(96)30711-2.

    PMID: 8594507BACKGROUND

  • Waring GO; Lynn MJ; McDonnell PJ; Resultados del estudio de evaluacion Prospectiva de la Queratotomia Radial (EPQR) 10 anos despues de la cirugia., Arch Ophthalmol (Edicion Espanola) 1995;6:99-110

    BACKGROUND

  • Nizam A; Waring GO; Lynn MJ; Stability of refraction during 11 years in eyes with simple myopia., Invest Ophthalmol Vis Sci 1996;37:S1004

    BACKGROUND

MeSH Terms

Conditions

Myopia

Interventions

Keratotomy, Radial

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

April 1, 1981

Study Completion

October 1, 1983

Last Updated

September 17, 2009

Record last verified: 2009-09