Incidence of Sub-clinical Cystoid Macular Edema After Cat... | NCT04161963

Studies
Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery

NCT04161963

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Mar 26, 2020Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Cataract
Glaucoma

Interventions

SD-OCT
OCT-A

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 4, 2019Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Nov 11, 2019

First Submission Date that Met QC Criteria

Nov 11, 2019

First Posted Date

Nov 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2020

Last Update Posted Date

Mar 26, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SD-OCT	Device	Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT	FLACS Phaco phaco+MIGS

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient who will undergo cataract surgery or combined catarct MIGS glaucoma surgery at the University Hospital Zurich

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marc Töteberg-Harms, MD, FEBO	Contact	+41442558794	+41442558794	marc.toeteberg@usz.ch

Overall Officials

Name	Affiliation	Role
Marc Töteberg-Harms, MD, FEBO	University Hospital Zurich, Department of Ophthalmology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology	Recruiting	Zurich	Canton of Zurich	8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract
D005901	Glaucoma

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D009798	Ocular Hypertension

Browse Leaves

Not provided

Browse Branches

Not provided