NCT02693353

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

3.1 years

First QC Date

February 24, 2016

Last Update Submit

March 17, 2019

Conditions

Macular EdemaEpiretinal Membrane

Outcome Measures

Primary Outcomes (1)

  • Cystoid Macular Edema diagnosed by OCT

    Within 90 days post op

Study Arms (2)

Study Group

Patients with diagnosed epiretinal membrane undergoing cataract surgery.

Control Group

Patients without epiretinal membrane undergoing cataract surgery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • years or older
  • Cataract surgery patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Macular EdemaEpiretinal Membrane

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • David Sierpina, MD

    Loma Linda University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 24, 2016

First Posted

February 26, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations

US(1)