Characters of Epiretinal Membranes in Patients With Previous Vitrectomy for Retinal Detachment
RD
Pathological Features of Epiretinal Membranes in Silicone Filled Eyes
2 other identifiers
interventional
31
1 country
1
Brief Summary
31 patients were included in the study,15 cases with ERM in silicone filled eyes and 16 eyes with idiopathic ERM
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 23, 2020
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedFebruary 28, 2020
February 1, 2020
6 months
February 23, 2020
February 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 months
Study Arms (2)
Silicone filled eyes
ACTIVE COMPARATOREyes filled with silicone oil
Idiopathic ERM
ACTIVE COMPARATOREyes not filled with silicone oil
Interventions
Removal of epiretinal membrane and ILM
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Diabetes mellitus/diabetic retinopathy. 3-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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta University
Tanta, El Gharbia, 31111, Egypt
Related Publications (1)
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.
PMID: 9076205RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Heba M Shafik, MD
Tanta University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Ophthalmology
Study Record Dates
First Submitted
February 23, 2020
First Posted
February 28, 2020
Study Start
January 1, 2019
Primary Completion
July 1, 2019
Study Completion
August 1, 2019
Last Updated
February 28, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share