Vitreomacular Interface Abnormalities in Diabetic Retinopathy Using OCT
1 other identifier
observational
50
0 countries
N/A
Brief Summary
to evaluate vitreomacular interface abnormalities in diabetic retinopathy by using Ocular Coherence Tomography (OCT)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2019
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2018
CompletedFirst Posted
Study publicly available on registry
September 27, 2018
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedJanuary 17, 2019
January 1, 2019
1 year
September 25, 2018
January 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
measuring visual acuity by snellen chart
measuring visual acuity by snellen chart full ophthalmic examination dilating the pupil by mydriatic 1-tropicamide1%drop phenylephrine 2.5%eye drop fundus photography is achived by using TRC 8PLUS TOPCON MEDICAL System,Inc OCT imaging is achived by using Spectral domain OCT (hiedelbrge)
two hours
Interventions
imaging by ocular coherence tomography
Eligibility Criteria
diabetic male and female patient with age between 12 and 70 years who live in Asiut city
You may qualify if:
- diabetic patient with or without treatment and with or without evidence of vitreomacular traction on clinical examination
You may not qualify if:
- diabetic patient with unclear media as dense cataract,
- vitreous Hemorrhage and corneal opacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
1- Agarwal D, Gelman R, Ponce CP, Stevenson W, and . Christoforidis J B the vitreo macular interface abnormalities in diabetic retinopathy . review. . journal of ophthalmology . 2015. 2- Bottós J, Elizalde J, Arevalo JF, Rodrigues EB, Maia M. Vitreomacular traction syndrome. J Ophthalmic Vis Res 2012 3- Duker JS, Kaiser PK, Binder S, de Smet MD, Gaudric A, Reichel E, et al. The International Vitreomacular Traction Study Group classification of vitreomacular adhesion, traction, and macular hole. Ophthalmology 2013 4- konsantanidis L , Wolfensberger TJ .cystoid macular edema and vitreomacular traction . a review .2015 5- Ryan SJ, Puliafito CA, Davis JL, Parel JM, Milne P. Retina. 4th ed. Philadelphia, PA:Elsevier Mosby; 2006. 6- Chandra A, Charteris DG, Yorston D. Posturing after macular hole surgery: a review. Ophthalmologica 2011
RESULT
Study Officials
- STUDY CHAIR
abdalnaser kamil
Asiut university
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ophthalmology specaliist
Study Record Dates
First Submitted
September 25, 2018
First Posted
September 27, 2018
Study Start
February 1, 2019
Primary Completion
February 1, 2020
Study Completion
March 1, 2021
Last Updated
January 17, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- the IPD will be available 2019 and for two years
- Access Criteria
- the IPD wiil be shared in print out form and C.D form and will be shared with Dr sharaf. mohamed and Dr abdlanaser .Kamil
all IPD data will be shared include the age of the patient his heath condition an all information regarding his vision and ophthalmic data and fudus photoes and OCT imaging