Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery (ICCME)
Studieoversikt
Detaljert beskrivelse
Subclinical cystoid macular edema (CME) can limit visual acuity after cataract surgery. Little is known whether the incidence is similar between standard ultrasound phacoemulsification cataract surgery (phaco), femtolaser assisted cataract surgery (FLACS), and combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery (phaco+MIGS) procedures.
The investigators hypothesize that CME incidence will be in the following order: FLACS < phaco < phaco+MIGS due to the increase of inflammation with the different surgical procedures.
The study is designed as a single centre, prospective study. The study includes patients with a diagnosis of cataract or cataract and glaucoma who will undergo one of the three above mentioned sürgical procedures at the Department of Ophthalmology at the UniversityHospital Zurich (USZ), Zurich, Switzerland. CME will be assessed by optical coherence tomography of the macular with Heidelberg Spectralis SD-OCT of the Macular at: baseline (i.e. preoperative), 1 week, 1 month, 3 months, and 6 months post-surgery. Furthermore, a swept source Optical Coherence Tomography Angiography (OCT-A) using Zeiss Plex Elite 9000 will be performed at: baseline (i.e. preoperative), 1 week, 1 month, and 6 months post-surgery to image the retinal vessels.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
ZH
-
Zurich, ZH, Sveits, 8091
- Rekruttering
- Department of Ophthalmology
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients with a diagnosis of cataract or
- Patients with a diagnosis of cataract and open angle glaucoma
- Signed lnformed Consent
- Patients at the age of 18 or older
Exclusion Criteria:
- Loss of follow up, i.e. not available during the post-operation follow-up inteval.
- Previous known of CME, macular pathology (e.g., Diabetes, exudative age-related macular degeneration, status post retinal vein occlusion) or posterior uveitis.
- Patient unable to understand the study due to cognitive or linguistic incapacity.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Phaco
tandard ultrasound phacoemulsification cataract surgery
|
Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT
swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula
|
|
FLACS
femtolaser assisted cataract surgery
|
Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT
swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula
|
|
phaco+MIGS
combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery
|
Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT
swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
incidence of CME
Tidsramme: baseline/preop
|
incidence of subclinical cystoid macular edema
|
baseline/preop
|
|
incidence of CME
Tidsramme: 1 week postop +/- 4 days
|
incidence of subclinical cystoid macular edema
|
1 week postop +/- 4 days
|
|
incidence of CME
Tidsramme: 1 month postop +/-2 weeks
|
incidence of subclinical cystoid macular edema
|
1 month postop +/-2 weeks
|
|
incidence of CME
Tidsramme: 3 months postop +/-2 weeks
|
incidence of subclinical cystoid macular edema
|
3 months postop +/-2 weeks
|
|
incidence of CME
Tidsramme: 6 months postop +/-2 weeks
|
incidence of subclinical cystoid macular edema
|
6 months postop +/-2 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Marc Töteberg-Harms, MD, FEBO, University Hospital Zurich, Department of Ophthalmology
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ICCME
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