- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00906659
Visual Function, Center Point Thickness and Macular Volume After Photocoagulation
20. maj 2009 opdateret af: Hospital Juarez de Mexico
Correlation of Visual Function, Center Point Thickness and Macular Volume Changes Three Weeks After Focal Photocoagulation for Diabetic Macular Edema
The purpose of this study is to correlate changes of visual function three weeks after photocoagulation for macular edema, with changes of center point thickness and macular volume.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Photocoagulation for clinically significant macular edema is effective to reduce the incidence of moderate visual loss.
Selective photocoagulation for focal macular edema statistically reduces macular thickening, measured with optical coherence tomography, as early as two weeks after treatment, without significant changes over center point thickness.
Although anatomic improvement has been demonstrated with OCT, clinical improvement takes longer to be evident: the Early Treatment Diabetic Retinopathy Study describe that clinical differences in visual function are after the eight month, and all the treatment strategies for macular edema used in this study were associated with an increased rate of moderate visual loss, during the first six weeks.
Differences in research can achieve statistical significance, without clinical significance.
A study was conducted to identify changes of visual function three weeks after photocoagulation for focal macular edema, and to correlate them with changes of CPT and macular volume, in order to compare the behavior of anatomical changes with visual changes.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
89
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Distrito Federal
-
Mexico, Distrito Federal, Mexico, 07760
- Hospital Juarez de Mexico
-
-
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
40 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Target population were type 2 diabetics from Mexico City and its metropolitan area, accessible population were the patients who attended a General Hospital in Mexico City
Beskrivelse
Inclusion Criteria:
- type 2 diabetes
- regardless of diabetes duration and retinopathy severity level
- one or both eyes with focal clinically significant macular edema
- treated with selective or focal photocoagulation
- visual capacity under subjective refraction before and three weeks after treatment
- adequate quality 6 mm fast macular map both on the day of photocoagulation, and three weeks after it
Exclusion Criteria:
- patients with myopia over -6.00 diopters
- any retinal disease different from diabetic retinopathy at the moment of photocoagulation
- eyes with a thickened posterior vitreous
- eyes with vitreoretinal traction at the macula
- if they had required scatter photocoagulation before the three weeks evaluation
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
diabetic macular edema
type 2 patients who had been treated with selective photocoagulation for clinically significant macular edema
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
visual capacity (under subjective refractive correction was measured in decimal equivalent)
Tidsramme: before the treatment and 3 weeks after photocoagulation
|
before the treatment and 3 weeks after photocoagulation
|
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center point thickness (measured in µm)
Tidsramme: before the treatment and 3 weeks after photocoagulation
|
before the treatment and 3 weeks after photocoagulation
|
|
macular volume (measured in mm3)
Tidsramme: before the treatment and 3 weeks after photocoagulation
|
before the treatment and 3 weeks after photocoagulation
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Virgilio Lima Gomez, MD, MsC, Hospital Juarez de Mexico
- Studieleder: Dulce M Razo Blanco Hernandez, MD, Hospital Juarez de Mexico
- Ledende efterforsker: Aleyda S Cruz Diaz, MD, Hospital Juarez de Mexico
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. januar 2006
Primær færdiggørelse (Faktiske)
1. december 2007
Studieafslutning (Faktiske)
1. marts 2008
Datoer for studieregistrering
Først indsendt
19. maj 2009
Først indsendt, der opfyldte QC-kriterier
20. maj 2009
Først opslået (Skøn)
21. maj 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. maj 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. maj 2009
Sidst verificeret
1. maj 2009
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HJM 1453/08.02.26
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 .