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Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery (ICCME)

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Unknown

Conditions

Cataract
Glaucoma

Treatments

Device: OCT-A
Device: SD-OCT

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

150 participants in 3 patient groups

Phaco
Description:
tandard ultrasound phacoemulsification cataract surgery
Treatment:
Device: OCT-A
Device: SD-OCT
FLACS
Description:
femtolaser assisted cataract surgery
Treatment:
Device: OCT-A
Device: SD-OCT
phaco+MIGS
Description:
combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery
Treatment:
Device: OCT-A
Device: SD-OCT

Trial contacts and locations

1

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Central trial contact

Marc Töteberg-Harms, MD, FEBO

Data sourced from clinicaltrials.gov

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