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

Sponsor

University of Zurich (Other)

Overall Status

Unknown status

CT.gov ID

NCT04161963

Collaborator

(none)

150

Enrollment

Location

33.9

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Glaucoma	Device: SD-OCT Device: OCT-A

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery

Actual Study Start Date :

Mar 4, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Phaco tandard ultrasound phacoemulsification cataract surgery	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
FLACS femtolaser assisted cataract surgery	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
phaco+MIGS combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery	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

Arm

Intervention/Treatment

Phaco

tandard ultrasound phacoemulsification cataract surgery

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

FLACS

femtolaser assisted cataract surgery

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

phaco+MIGS

combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery

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

Outcome Measures

Primary Outcome Measures

incidence of CME [baseline/preop]
incidence of subclinical cystoid macular edema
incidence of CME [1 week postop +/- 4 days]
incidence of subclinical cystoid macular edema
incidence of CME [1 month postop +/-2 weeks]
incidence of subclinical cystoid macular edema
incidence of CME [3 months postop +/-2 weeks]
incidence of subclinical cystoid macular edema
incidence of CME [6 months postop +/-2 weeks]
incidence of subclinical cystoid macular edema

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.