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

February 25, 2020 updated by: Sharif Yousef El Emam, Tanta University

Pathological Features of Epiretinal Membranes in Silicone Filled Eyes

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Gharbia
      • Tanta, El Gharbia, Egypt, 31111
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

42 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of GFAP and CD cells in idiopathic and silicone oil ERM
Time Frame: 6 months
Percentage of glial fibrillary acid protein positive cells and number of cluster of differentiation cells in idiopathic and silicone oil ERM
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tanta University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Heba M Shafik, MD, Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IAA
  • Faculty of Medicine (Other Identifier: Thammasat University, Thailand)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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