Epiretinal Membrane and Pseudophakic Cystoid Macular Edema | NCT02693353

Studies
Epiretinal Membrane and Pseudophakic Cystoid Macular Edema

NCT02693353

Sponsor

Loma Linda University

Status

Terminated

Last Update Posted

Mar 19, 2019Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Macular Edema
Epiretinal Membrane

Interventions

Not provided

Countries

United States

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 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recent publication makes current study obsolete.

Expanded Access Info

Start Date

Feb 2016Actual

Primary Completion Date

Mar 2019Actual

Completion Date

Mar 2019Actual

First Submitted Date

Feb 24, 2016

First Submission Date that Met QC Criteria

Feb 24, 2016

First Posted Date

Feb 26, 2016Estimated

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 17, 2019

Last Update Posted Date

Mar 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Prospective, observational cohort study evaluating the association between pre-surgical existence of an epiretinal membrane (ERM) and the development of pseudophakic cystoid macular edema (PCME) using spectral domain optical coherence tomography (OCT) measurements.

Detailed Description

Not provided

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

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group		Patients with diagnosed epiretinal membrane undergoing cataract surgery.
Control Group		Patients without epiretinal membrane undergoing cataract surgery.

Interventions

Not provided

Measure	Description	Time Frame
Cystoid Macular Edema diagnosed by OCT		Within 90 days post op

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
Cataract surgery patients

Exclusion Criteria:

Pre-existing macular edema
Choroidal neovascularization
Uveitis
Age-related macular degeneration
Myopia > 6 diopters
Proliferative diabetic retinopathy
Diabetics retinopathy great than mild in serverity

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

All patients over 18 who are undergoing cataract surgery at Loma Linda University Eye Institute

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Sierpina, MD	Loma Linda University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Loma Linda University Medical Center		Loma Linda	California	92354	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008269	Macular Edema
D019773	Epiretinal Membrane

Ancestor Terms

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided