NCT03384901

Brief Summary

This study will be a retrospective analysis of vitrectomy results in patients suffering from diabetic macular edema.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

December 28, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

December 20, 2017

Last Update Submit

December 20, 2017

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Visual acuity will be measured using the Snellen Chart before and after vitrectomy

    6 months

Secondary Outcomes (1)

  • Macular thickness

    6 months

Interventions

vitrectomyPROCEDURE

Pars plana vitrectomy and ILM (internal limiting membrane) peeling

Eligibility Criteria

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

Patients attending the Hillel Yaffe Medical Center Ophthalmology Clinic

You may qualify if:

  • Diabetic macular edema patients after vitrectomy

You may not qualify if:

  • All others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hille Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Eran Berkowitz, MD

CONTACT

972-54-6455753eran.berko@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2017

First Posted

December 28, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

December 28, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)