Characters of Epiretinal Membranes in Patients With Previ... | NCT04288440

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

NCT04288440

Sponsor

Tanta University

Status

Completed

Last Update Posted

Feb 28, 2020Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Rhegmatogenous Retinal Detachment of Both Eyes (Diagnosis)

Interventions

Surgery
Vitrectomy machine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Faculty of medicine	Other Identifier	Tanta University

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jul 1, 2019Actual

Completion Date

Aug 1, 2019Actual

First Submitted Date

Feb 23, 2020

First Submission Date that Met QC Criteria

Feb 25, 2020

First Posted Date

Feb 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2020

Last Update Posted Date

Feb 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Silicone filled eyes	Active Comparator	Eyes filled with silicone oil	Procedure: Surgery Device: Vitrectomy machine
Idiopathic ERM	Active Comparator	Eyes not filled with silicone oil	Procedure: Surgery Device: Vitrectomy machine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery	Procedure	Removal of epiretinal membrane and ILM	Idiopathic ERM Silicone filled eyes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

42 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Heba M Shafik, MD	Tanta University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University		Tanta	El Gharbia	31111	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9076205	Result	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.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013514	Surgical Procedures, Operative
D019060	Minimally Invasive Surgical Procedures