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

Not Applicable

Completed

• Conditions: Rhegmatogenous Retinal Detachment of Both Eyes (Diagnosis)
• Interventions: Procedure: Surgery; Device: Vitrectomy machine

• Registration Number: NCT04288440
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-08-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-23
• Study First Submitted QC: 2020-02-25
• Last Update Submitted: 2020-02-25
• Study First Posted: 2020-02-28
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Exclusion Criteria

the investigator excluded 1-patients with previous intraocular surgery (except cataract surgery) for the control group.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silicone filled eyes	Vitrectomy machine	Eyes filled with silicone oil
Idiopathic ERM	Surgery	Eyes not filled with silicone oil
Idiopathic ERM	Vitrectomy machine	Eyes not filled with silicone oil
Silicone filled eyes	Surgery	Eyes filled with silicone oil

Primary Outcome Measures

Name	Time	Method
Percentage of GFAP and CD cells in idiopathic and silicone oil ERM	6 months	Percentage of glial fibrillary acid protein positive cells and number of cluster of differentiation cells in idiopathic and silicone oil ERM

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El Gharbia, Egypt