Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery

Cataract Clinical Trial

— ICCME  

Official title:

Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04161963
• Other study ID #: ICCME
• Status: Recruiting
• Start date: March 4, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2020
• Source: University of Zurich
• Contact: Marc Töteberg-Harms, MD, FEBO
• Phone: +41442558794
• Email: marc.toeteberg[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Glaucoma
• Macular Edema

Intervention

Device:
• SD-OCT
Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT
• OCT-A
swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula

Locations

Country	Name	City	State
Switzerland	Department of Ophthalmology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of CME	incidence of subclinical cystoid macular edema	baseline/preop
Primary	incidence of CME	incidence of subclinical cystoid macular edema	1 week postop +/- 4 days
Primary	incidence of CME	incidence of subclinical cystoid macular edema	1 month postop +/-2 weeks
Primary	incidence of CME	incidence of subclinical cystoid macular edema	3 months postop +/-2 weeks
Primary	incidence of CME	incidence of subclinical cystoid macular edema	6 months postop +/-2 weeks