- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00712231
Limitations of Using a Sheimpflug Image-Based Device for Measuring Anterior Chamber Depth in Pseudophakic Eyes
8. juli 2008 opdateret af: Far Eastern Memorial Hospital
To Assess the Degree of Agreement of Anterior Chamber Depth Measurements by 2 Optical Devices (Pentacam and IOLMaster) and Compare Them With Contact Ultrasound A-Scan in Phakic and Pseudophakic Eyes.
There have been numerous studies comparing various ACD measurements in phakic eyes,while researches comparing ACD in pseudophakic eyes are less extensive.
With the recent popularity of presbyopia correction, measuring the ACD will facilitate differentiating pseudophakic accommodation from pseudoaccommodation.
It is thus mandatory to verify the accuracy of ACD measurement of these devices since the innovation of various IOLs in the recent decade makes this task more complicated.
In this study, we will assess the limitations of using Pentacam for ACD measurement in pseudophakic eyes and compare Pentacam measurement with IOLMaster and A-scan measurements.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
In this prospective study, ACD was measured in 90 phakic and 94 pseudophakic eyes by Pentacam, IOLMaster and A-scan.
Correlations and differences between the three measurements were investigated.
The accuracy in detecting the anterior lens surface in pseudophakic eyes was also assessed.Differences in ACD-Pen, ACD-IOLM, and ACD-A were analyzed using one-way analysis of variance (ANOVA).
When an overall significance of P< 0.05 was obtained, pair-wise comparisons were made using Tukey's multiple comparison t tests.
The association between ACD-Pen, ACD-IOLM, and ACD-A was assessed using Pearson's correlation test.
The distribution of erroneous ACD-Pen measurement for the three IOLs was analyzed with the chi-square test.
In all analyses, P <0.05 was considered statistically significant.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
184
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 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Ninety phakic eyes were randomly selected for study from the outpatient clinic.
Ninety-four pseudophakic eyes that had a standard clear cornea phacoemulsification with one of three acrylic IOLs (MA60BM, SA60AT, SN60AT) implanted into the capsular bag by the same surgeon were also studied.
Beskrivelse
Inclusion Criteria:
- Phakic group: randomized
- Pseudophakic eyes : the cases accepted cataract surgery
Exclusion Criteria:
- Previous ocular trauma or intraocular surgery other than cataract surgery;
- Contact lens use in the past two months;
- Use of medication that might affect the pupil; corneal disease or ocular infection;
History of ocular disease, such as
- Dry eye syndrome
- Uveitis
- Glaucoma
- Ocular tumor
- Cases with any surgical complications were also excluded.
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 |
---|
phakic eyes
the cases did not accept any intraocular surgery
|
pseudophakic eyes
tht cases did not accept any intraocular surgery expect for cataract surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Shu-Wen Chang, Far Eastern Memorial Hospital
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 2008
Primær færdiggørelse (Faktiske)
1. februar 2008
Studieafslutning (Faktiske)
1. februar 2008
Datoer for studieregistrering
Først indsendt
7. juli 2008
Først indsendt, der opfyldte QC-kriterier
8. juli 2008
Først opslået (Skøn)
9. juli 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. juli 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juli 2008
Sidst verificeret
1. juli 2008
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FEMH97007
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