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Vitrectomy With Planned Foveal Detachment for Refractory DME With or Without Vitreo-macular Interface Abnormality

NCT ID: NCT03345056

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-11-30

Brief Summary

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To evaluate the therapeutic efficacy of sub retinal BSS injections in conjunction with conventional vitrectomy for refractory Diabetic macular edema (DME)- resistant to more than one anti-VEGF agent, intravitreal corticosteroids and to previous vitrectomy. Some of enrolled cases had normal vitreo-macular interface (VMI) relationship, while other cases had incomplete vitreoretinal separation with vitreomacular attachment (VMA).

Detailed Description

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Conditions

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Chronic Edema of the Macula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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included cases

vitrectomy done with planned foveal separation and followed for the result

Group Type OTHER

vitrectomy with planned foveal detachment

Intervention Type PROCEDURE

23 gauge vitrectomy, posterior hyaloid detachment, internal limiting membrane peeling , sub-macular BSS injection using 38 gauge canula

Interventions

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vitrectomy with planned foveal detachment

23 gauge vitrectomy, posterior hyaloid detachment, internal limiting membrane peeling , sub-macular BSS injection using 38 gauge canula

Intervention Type PROCEDURE

Other Intervention Names

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vitrectomy with submacular BSS injection

Eligibility Criteria

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Inclusion Criteria

* Cases with refractory DME with a central macular thickness (CMT) of more than 300 µm despite undergoing anti-VEGF therapy (5-6 monthly injections of ranibizumab (IVR) or bevacizumab (IVB) with shifting to aflibercept (IVA) for additional 3 injections).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health and Population, Egypt

OTHER_GOV

Sponsor Role lead

Responsible Party

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ahmed M. Abdel hadi

Assistant professor of ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Abdel Hadi AM. Evaluation of Vitrectomy with Planned Foveal Detachment as Surgical Treatment for Refractory Diabetic Macular Edema with or without Vitreomacular Interface Abnormality. J Ophthalmol. 2018 May 7;2018:9246384. doi: 10.1155/2018/9246384. eCollection 2018.

Reference Type DERIVED
PMID: 29854429 (View on PubMed)

Other Identifiers

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MOHEgypt

Identifier Type: -

Identifier Source: org_study_id