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

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT04288440
Collaborator
(none)
31
Enrollment
1
Location
2
Arms
7
Actual Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surgery
  • Device: Vitrectomy machine
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
Pathological Features of Epiretinal Membranes in Silicone Filled Eyes
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Silicone filled eyes

Eyes filled with silicone oil

Procedure: Surgery
Removal of epiretinal membrane and ILM
Other Names:
  • Invasive procedure

    • Device: Vitrectomy machine
    Pars plana vitrectomy
    Active Comparator: Idiopathic ERM

    Eyes not filled with silicone oil

    Procedure: Surgery
    Removal of epiretinal membrane and ILM
    Other Names:
  • Invasive procedure

    • Device: Vitrectomy machine
    Pars plana vitrectomy

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    42 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta University Tanta El Gharbia Egypt 31111

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Study Chair: Heba M Shafik, MD, Tanta University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sharif Yousef El Emam, Lecturer of Ophthalmology, Tanta University
    ClinicalTrials.gov Identifier:
    NCT04288440
    Other Study ID Numbers:
    • IAA
    • Faculty of medicine
    First Posted:
    Feb 28, 2020
    Last Update Posted:
    Feb 28, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Retinal Detachment
    Epiretinal Membrane

    Study Results

    No Results Posted as of Feb 28, 2020