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Status unknownNCT03686436Updated Jan 17, 2019

Vitreomacular Interface Abnormalities in Diabetic Retinopathy Using OCT

An observational study in on Vitreomacular Interface Abnormalities in Diabetic Retinopathy, sponsored by Assiut University. Status unknown. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-01-17.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
12 Years to 70 Years
Sex
All
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Study summary

to evaluate vitreomacular interface abnormalities in diabetic retinopathy by using Ocular Coherence Tomography (OCT)

Read the detailed description

Diabetic retinopathy (DR) is a leading health concern and a major cause of blindness .DR can be complicated by scar tissue formation, macular edema tractional retinal detachment. Optical coherence tomography has found patient with DR has diffuse retinal thickening , cystoid macular edema ,posterior hayaloid traction ,tractional retinal detachment.

The VMI in patient with DR can influence the emergence ,progression ,and treatment of DR.

The role of posterior hyaloid and vitreous on viteromacular interface abnormalities The anomalous separation of vitreous cortex from ILM can lead to abnormal vitreomacular interface. This separation can happen when liquefaction occur faster than detachment of the vitreous cortex or when an abnormal adhesion of the vitreous cortex to the ILM occur.

The VMI abnormalities in DR include I. Vitreomacular adhesion The International Vitreomacular Traction Study group has defined the vitremacular adhesion as specific stage of vitreous separation when partial detachment of the vitreous in perifoveal area has occurred without any abnormalities to the retinal contour.

II. Vitreomacular traction There is abnormal vitreous adhesion, there can be excessive traction on the macula from the vitreous that change the contour of foveal surface. By OCT any distortion of foveal contour together with partial posterior vitreous detachment is considered vitreomacular traction . In accordance with the International Vitreomacular Traction Study Group definition vitreomacular traction can be classified as focal or broad based on horizontal area of adhesion.

III. Cystoid macular edema The vitreous has been implicated as a cause of macular edema via mechanical and physiologic mechanisms.One of the most constructive hypothesis on how vitreomacular traction may result in macular edema was given by Schubert in 1989,and was summarized by Bringmann and Wiedmann Vitro retinal traction can also exert forces at the level of retinal pigment epithelium ,which can eventually result in morphological retinal pigment epithelial changes .

IV. Epiretinal membrane The epiretinal membrane is a cellular proliferation that creates a semi translucent, fibrocellular proliferation on the surface of the inner retina. Because epiretinal membrane contain contractile cellular elements they can be associated with retinal folding and macular thickening thereby leading to decreased visual acuity, metamorphopsia, monocular diplopia .

V. Full thickness hole Is a full thickness defect in the fovea, include the complete interruption of all retinal layers from the ILM to the retinal pigment epithelium. antero posterior traction, secondary to abnormal attachment at the fovea, and tangential contraction of the perifoveal vitreous cortex may be responsible for the development of the macular hole.

VI. Lamellar holes These include an irregular foveal contour, a defect or break in the inner fovea, a splitting of the inner and outer retina , lack of a full thickness foveal defect, and intact photo receptors.

VII. Macular pseudo hole By OCT the pseudo hole has no loss of retinal tissue. They have invaginated or heaped foveal edge, an epiretinal membrane with a central opening ,and a steep macular contour to the central fovea .the steep foveal contour creates the appearance of hole, even though there is no loss of retinal tissue.

Aim of work Primary outcome : To evaluate the changes in vitreomacular interface in diabetic retinopathy by using Spectral Domain Ocular Coherence Tomography ( SD OCT) Secondary outcome : To evaluate other macular changes in Spectral Domain Ocular Coherence Tomography ( SD OCT) in diabetic patient with vitreomacular interface abnormalities

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Conditions studied

  • on Vitreomacular Interface Abnormalities in Diabetic Retinopathy

Keywords

  • unrecognized condition
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In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's planned enrollment of 50 is below the median of 180 across 282 observational studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

diabetic male and female patient with age between 12 and 70 years who live in Asiut city

Inclusion criteria

  • diabetic patient with or without treatment and with or without evidence of vitreomacular traction on clinical examination

Exclusion criteria

Exclusion Criteria:

  • diabetic patient with unclear media as dense cataract,
  • vitreous Hemorrhage and corneal opacity
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Deviceocular coherence tomography

    imaging by ocular coherence tomography

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What researchers measure

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)

    Time frame: two hours

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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

Individual participant data

Plan to share: Yes — 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

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03686436
Lead sponsor
Assiut University
Responsible party
seham dahy (ophthalmology specaliist, Assiut University) — Principal investigator
First posted
Sep 27, 2018
Start date
Feb 1, 2019 (estimated)
Primary completion
Feb 1, 2020 (estimated)
Completion
Mar 1, 2021 (estimated)
Last update
Jan 17, 2019

Study contacts

dahy seham, M.B.B.CH
Contact
dahyseham@yahoo.com
+2001012060672
sharaf mohamed
Contact
01001088252
abdalnaser kamil
study chair · Asiut university

Oversight

Data monitoring committee
No
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 Jan 2019. You cannot join it, but the record below documents what was studied.

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