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Evaluation of Conventional Photorefractive Keratectomy (PRK) in U.S. Army Personnel, Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army Personnel

31. marts 2008 opdateret af: Walter Reed Army Medical Center

The purpose of this study is to:

  1. evaluate the safety and efficacy of conventional PRK in U.S. Army personnel who have naturally occurring myopia with or without astigmatism.
  2. compare the data from this control group to study groups undergoing wavefront guided PRK.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20302
        • Walter Reed Army Medical Center, Center For Refractive Surgery

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
  2. Manifest refractive spherical equivalent (MSE) of up to 6.00 diopters (D) at the spectacle plane with refractive cylinder up to 3.00 D.
  3. Manifest refraction and LADARWave™ refractions must be within 1.00 D.
  4. Best spectacle corrected visual acuity of 20/20 or better in both eyes.
  5. Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50D during the 12-month period immediately preceding the baseline examination, as confirmed by clinical records.
  6. Soft contact lens users must have removed their lenses at least 2 weeks before baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least 4 weeks prior to baseline measurements and have 2 central keratometry readings and 2 manifest refractions taken at least 1 week apart that do not differ by more than 0.50 D in either meridian; mires should be regular.
  7. Located in the greater Washington DC area for a 12-month period.
  8. Consent of the subject's command (active duty) to participate in the study.
  9. Access to transportation to meet follow-up requirements.

Exclusion Criteria:

  1. Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy.
  2. Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and/or sumatripin (Imitrex).
  3. Medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex.
  4. Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or clinically significant lens opacity.
  5. Evidence of glaucoma or an intraocular pressure greater than 22 mm Hg at baseline.
  6. Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
  7. History of recurrent erosions or epithelial basement dystrophy.
  8. Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
  9. Any physical or mental impairment that would preclude participation in any of the examinations.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1
PRK control group
vision correction with PRK

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
safety, efficacy, and refractive stability
Tidsramme: one year after procedure
one year after procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: KRAIG S. BOWER, MD, Walter Reed Army Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2004

Studieafslutning

1. marts 2008

Datoer for studieregistrering

Først indsendt

15. december 2006

Først indsendt, der opfyldte QC-kriterier

15. december 2006

Først opslået (Skøn)

18. december 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. april 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. marts 2008

Sidst verificeret

1. november 2007

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • WRAMC WU # 04-2335-99d
  • WU #2335-99 (master protocol)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Photorefractive Keratectomy (PRK)

3
Abonner