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
| Type | Name | Description |
|---|---|---|
| DEVICE | SD-OCT | Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT |
| DEVICE | OCT-A | swept 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.