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Characters of Epiretinal Membranes in Patients With Previous Vitrectomy for Retinal Detachment

NCT ID: NCT04288440

Last Updated: 2020-02-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-08-01

Brief Summary

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31 patients were included in the study,15 cases with ERM in silicone filled eyes and 16 eyes with idiopathic ERM

Detailed Description

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This is a prospective study that included 31 patients and was performed in Tanta University Eye Hospital in cooperation with the Pathology Department, Tanta University, between January 2018 and June 2019. The approval of the ethical committee of the Faculty of Medicine in Tanta University was obtained, and the study was conducted in accordance with the 1964 Helsinki Declaration and its later amendment. A detailed informed written consent was signed by all study participants. The research is not funded by the university or any organization or entity.

Fifteen cases had pars plana vitrectomy for rhegmatogenous retinal detachment nine months earlier with ERM detected by OCT one day before silicone oil removal. The other 16 cases matched for age and gender with idiopathic ERM and were included as a control. Histopathological features of the ERMs were compared between the two groups.

All patients have undergone complete ophthalmic evaluation including: best corrected visual acuity (BCVA) by Snellen chart that was converted to log MAR for statistical analysis, anterior segment examination by slit lamp, posterior segment examination by slit lamp bimicroscopy using +78 D lens and indirect Ophthalmoscopy, and Spectral domain optical coherence tomography (SD-OCT) (Spectralis; Heidelberg Engineering,Heidelberg, Germany) was performed for all patients before surgery.

The investigators excluded patients with previous intraocular surgery (except cataract surgery) for the control group, diabetes mellitus/diabetic retinopathy, coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration, previous laser photocoagulation, intravitreal injection of Triamcinolone Acetonide or antivascular endothelial growth factor (anti-VEGF) agents, prior intra-ocular inflammation, retinal degenerations, neovascularization or rubeosis and vascular disorders e.g. retinal vein or artery occlusion.

Conditions

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Rhegmatogenous Retinal Detachment of Both Eyes (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Silicone filled eyes

Eyes filled with silicone oil

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

Removal of epiretinal membrane and ILM

Vitrectomy machine

Intervention Type DEVICE

Pars plana vitrectomy

Idiopathic ERM

Eyes not filled with silicone oil

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

Removal of epiretinal membrane and ILM

Vitrectomy machine

Intervention Type DEVICE

Pars plana vitrectomy

Interventions

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Surgery

Removal of epiretinal membrane and ILM

Intervention Type PROCEDURE

Vitrectomy machine

Pars plana vitrectomy

Intervention Type DEVICE

Other Intervention Names

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Invasive procedure

Eligibility Criteria

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Inclusion Criteria

1. Fifteen cases had pars plana vitrectomy for rhegmatogenous retinal detachment nine months earlier with ERM detected by OCT one day before silicone oil removal.
2. The other 16 cases matched for age and gender with idiopathic ERM and were included as a control. Histopathological features of the ERMs were compared between the two groups.

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Exclusion Criteria

2- Diabetes mellitus/diabetic retinopathy. 3-Coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration.

4-previous laser photocoagulation, intravitreal injection of Triamcinolone Acetonide or antivascular endothelial growth factor (anti-VEGF) agents.

5- prior intra-ocular inflammation, retinal degenerations.

6-Neovascularization or rubeosis and vascular disorders e.g. retinal vein or artery occlusion.

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Minimum Eligible Age

42 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Sharif Yousef El Emam

Lecturer of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heba M Shafik, MD

Role: STUDY_CHAIR

Tanta University

Locations

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Tanta University

Tanta, El Gharbia, Egypt

Site Status

Countries

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Egypt

References

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Abrams GW, Azen SP, McCuen BW 2nd, Flynn HW Jr, Lai MY, Ryan SJ. Vitrectomy with silicone oil or long-acting gas in eyes with severe proliferative vitreoretinopathy: results of additional and long-term follow-up. Silicone Study report 11. Arch Ophthalmol. 1997 Mar;115(3):335-44. doi: 10.1001/archopht.1997.01100150337005.

Reference Type RESULT
PMID: 9076205 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov.

medical link that contains hundreds of scientific papers

Other Identifiers

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Faculty of medicine

Identifier Type: OTHER

Identifier Source: secondary_id

IAA

Identifier Type: -

Identifier Source: org_study_id