CClinicalTrials.gg
Status unknownNCT03384901Updated Dec 28, 2017

The Results of Pars Plana Vitrectomy in Diabetic Macular Edema

An observational study in Diabetic Macular Edema, sponsored by Hillel Yaffe Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-28.

Sponsored by Hillel Yaffe Medical Center · Observational

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetic Macular Edema
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients attending the Hillel Yaffe Medical Center Ophthalmology Clinic

Inclusion criteria

  • Diabetic macular edema patients after vitrectomy

Exclusion criteria

Exclusion Criteria:

  • All others
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
70 participants (estimated)
Patient registry
No

Interventions

  • Procedurevitrectomy

    Pars plana vitrectomy and ILM (internal limiting membrane) peeling

05

What researchers measure

Primary outcomes

  1. Visual acuity

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

    Time frame: 6 months

Secondary outcomes

  1. Macular thickness

    Macular thickness will be measured using Optical Coherence Tomography before and after vitrectomy

    Time frame: 6 months

06

Study locations

1 site
  • Hille Yaffe Medical Center
    Hadera, 38100, Israel
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03384901
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Sponsor
First posted
Dec 28, 2017
Start date
Jan 2018 (estimated)
Primary completion
Jan 2019 (estimated)
Completion
Jan 2019 (estimated)
Last update
Dec 28, 2017

Study contacts

Eran Berkowitz, MD
Contact
eran.berko@gmail.com
972-54-6455753

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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