Clinical Trials Directory

Trials / Unknown

UnknownNCT04161963

Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery

Status
Unknown
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
University of Zurich · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICESD-OCTOptical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT
DEVICEOCT-Aswept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula

Timeline

Start date
2019-03-04
Primary completion
2021-12-31
Completion
2021-12-31
First posted
2019-11-13
Last updated
2020-03-26

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04161963. Inclusion in this directory is not an endorsement.