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

Primary Purpose

Rhegmatogenous Retinal Detachment of Both Eyes (Diagnosis)

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Surgery
Vitrectomy machine
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rhegmatogenous Retinal Detachment of Both Eyes (Diagnosis)

Eligibility Criteria

42 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

-

Sites / Locations

  • Tanta University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Silicone filled eyes

Idiopathic ERM

Arm Description

Eyes filled with silicone oil

Eyes not filled with silicone oil

Outcomes

Primary Outcome Measures

Percentage of GFAP and CD cells in idiopathic and silicone oil ERM
Percentage of glial fibrillary acid protein positive cells and number of cluster of differentiation cells in idiopathic and silicone oil ERM

Secondary Outcome Measures

Full Information

First Posted
February 23, 2020
Last Updated
February 25, 2020
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04288440
Brief Title
Characters of Epiretinal Membranes in Patients With Previous Vitrectomy for Retinal Detachment
Acronym
RD
Official Title
Pathological Features of Epiretinal Membranes in Silicone Filled Eyes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhegmatogenous Retinal Detachment of Both Eyes (Diagnosis)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silicone filled eyes
Arm Type
Active Comparator
Arm Description
Eyes filled with silicone oil
Arm Title
Idiopathic ERM
Arm Type
Active Comparator
Arm Description
Eyes not filled with silicone oil
Intervention Type
Procedure
Intervention Name(s)
Surgery
Other Intervention Name(s)
Invasive procedure
Intervention Description
Removal of epiretinal membrane and ILM
Intervention Type
Device
Intervention Name(s)
Vitrectomy machine
Intervention Description
Pars plana vitrectomy
Primary Outcome Measure Information:
Title
Percentage of GFAP and CD cells in idiopathic and silicone oil ERM
Description
Percentage of glial fibrillary acid protein positive cells and number of cluster of differentiation cells in idiopathic and silicone oil ERM
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. - 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba M Shafik, MD
Organizational Affiliation
Tanta University
Official's Role
Study Chair
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El Gharbia
ZIP/Postal Code
31111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9076205
Citation
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov.
Description
medical link that contains hundreds of scientific papers

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

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