NCT03489915

Brief Summary

Correlation between changes observed in OCT and VA in patients with retinal vein occlusion whether the patient's VA improves when macular edema improves in OCT or not ??

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

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 23, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

April 6, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

March 23, 2018

Last Update Submit

April 4, 2018

Conditions

Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (2)

  • Macular edema assessment

    Macular edema assessed by OCT in microns

    5 minutes

  • Visual acuity assessment

    Visual acuity assessment through Landolt chart

    5 minutes

Secondary Outcomes (1)

  • Causes of non improvement of visual acuity in patients with resolving macular edema

    5 minutes

Study Arms (1)

Patients with macular edema due to RVO

assessment of visual acuity using Landolt chart and follow up of macular edema using OCT

Device: OCT

Interventions

OCTDEVICE

Assessment of macular edema secondary to retinal vein occlusion usin optical coherence tomography and its correlation with visual acuity

Patients with macular edema due to RVO

Eligibility Criteria

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

in patients developing retinal vein occlusion for following up their changes in OCT \& VA

You may qualify if:

  • Patients with macular edema related to vein occlusion .
  • Patient's Age above 18 years old .
  • Patients able to sit on OCT device .

You may not qualify if:

  • Significant cataract .
  • Media opacities as vitreous haemorrhage .
  • patients with macular edema related to CRVO treated by laser photocoagulation .
  • patients with glaucoma .
  • Patients with chronic uveitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Natural history and clinical management of central retinal vein occlusion. The Central Vein Occlusion Study Group. Arch Ophthalmol. 1997 Apr;115(4):486-91. doi: 10.1001/archopht.1997.01100150488006.

    PMID: 9109757BACKGROUND

  • Hayreh SS. Classification of central retinal vein occlusion. Ophthalmology. 1983 May;90(5):458-74. doi: 10.1016/s0161-6420(83)34530-9.

    PMID: 6877778BACKGROUND

  • Hayreh SS. Retinal vein occlusion. Indian J Ophthalmol. 1994 Sep;42(3):109-32.

    PMID: 7829175BACKGROUND

  • Williamson TH. Central retinal vein occlusion: what's the story? Br J Ophthalmol. 1997 Aug;81(8):698-704. doi: 10.1136/bjo.81.8.698. No abstract available.

    PMID: 9349161BACKGROUND

  • Hayreh SS, Zimmerman MB, Podhajsky P. Incidence of various types of retinal vein occlusion and their recurrence and demographic characteristics. Am J Ophthalmol. 1994 Apr 15;117(4):429-41. doi: 10.1016/s0002-9394(14)70001-7.

    PMID: 8154523RESULT

  • Moschos MM, Moschos M. Intraocular bevacizumab for macular edema due to CRVO. A multifocal-ERG and OCT study. Doc Ophthalmol. 2008 Mar;116(2):147-52. doi: 10.1007/s10633-007-9110-9. Epub 2008 Jan 10.

    PMID: 18189152RESULT

  • Gupta B, Grewal J, Adewoyin T, Pelosini L, Williamson TH. Diurnal variation of macular oedema in CRVO: prospective study. Graefes Arch Clin Exp Ophthalmol. 2009 May;247(5):593-6. doi: 10.1007/s00417-008-1011-4. Epub 2008 Dec 4.

    PMID: 19052771RESULT

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Abdelsalam a Mohamed, ass. prof.

    Assiut University

    STUDY CHAIR

Central Study Contacts

Samir Y Saleh, professor

CONTACT

00201003304320samir.abouelail@med.au.edu.eg

waleed s Mohamed, lecturer

CONTACT

002012223971491walidibrahim72@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 6, 2018

Study Start

May 1, 2018

Primary Completion

March 30, 2020

Study Completion

May 1, 2020

Last Updated

April 6, 2018

Record last verified: 2018-04