NCT04312620

Brief Summary

To evulate changes in VF and OCT after viterctomy associated with ILM peeling.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

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

March 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2021

Completed
Last Updated

March 18, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

March 16, 2020

Last Update Submit

March 16, 2020

Conditions

ILM Peeling

Outcome Measures

Primary Outcomes (1)

  • BCVA

    ILM peeling

    6 months

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients withIdiopathic ERM,Primary full thickness macular hole,Lamellar macular hole, andVitromacular traction

You may qualify if:

  • Idiopathic ERM,
  • Primary full thickness macular hole,
  • Lamellar macular hole, and
  • Vitromacular traction.

You may not qualify if:

  • Patients with a secondary ERM,
  • diabetic retinopathy,
  • venous occlusion,
  • retinal detachment,
  • uveitis, and
  • trauma. 2-Other ocular pathologies that could interfere with the functional results
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  • dense cataract ,
  • glaucoma, and
  • previous retinal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Noma H, Funatsu H, Sakata K, Harino S, Mimura T, Hori S. Macular microcirculation in hypertensive patients with and without branch retinal vein occlusion. Acta Ophthalmol. 2009 Sep;87(6):638-42. doi: 10.1111/j.1755-3768.2008.01318.x. Epub 2008 Jul 8.

    PMID: 18631327BACKGROUND

  • Higashide T, Ohkubo S, Hangai M, Ito Y, Shimada N, Ohno-Matsui K, Terasaki H, Sugiyama K, Chew P, Li KK, Yoshimura N. Influence of Clinical Factors and Magnification Correction on Normal Thickness Profiles of Macular Retinal Layers Using Optical Coherence Tomography. PLoS One. 2016 Jan 27;11(1):e0147782. doi: 10.1371/journal.pone.0147782. eCollection 2016.

    PMID: 26814541RESULT

Central Study Contacts

almoatz bellah zohier mohamm,ed, master

CONTACT

01099490013moatazmoh58@gmail.com

magady mostafa, professor

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 18, 2020

Study Start

April 1, 2020

Primary Completion

February 9, 2021

Study Completion

April 8, 2021

Last Updated

March 18, 2020

Record last verified: 2020-02