Multifocal Electroretinography Before and After Silicone Oil Removal
Sponsor
Minia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05087901
Collaborator
(none)
30
1
5.9
5
Study Details
Study Description
Brief Summary
This is a prospective observational study to investigate the changes in multifocal electroretinogram signal before and after silicone oil removal in silicone-filled eyes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multifocal Electroretinography Before and After Silicone Oil Removal
Actual Study Start Date
:
Oct 1, 2021
Anticipated Primary Completion Date
:
Jan 31, 2022
Anticipated Study Completion Date
:
Mar 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Silicone-filled eyes
|
Diagnostic Test: Multifocal electroretinogram
A device that records electric potentials generated by the retinal photoreceptors and neural elements in a multifocal fashion
|
Outcome Measures
Primary Outcome Measures
- Change in Amplitude [Preoperative and 1 month postoperative recordings]
Change in amplitudes of P1 and N1 waves before and after silicone oil removal
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients 18 years of age or older who underwent pars plana vitrectomy for the repair of rhegmatogenous retinal detachment (RRD) and received silicone oil as an intraocular tamponade.
Exclusion Criteria:
- Patients will be excluded if they have a significant corneal opacity, uncontrolled intraocular pressure, a confounding macular pathology or optic nerve pathology or if silicone oil has been in the eye for longer than 6 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Minia University Hospital | Minya | Egypt | 61111 |
Sponsors and Collaborators
- Minia University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mohamed Abdel Hamid,
Dr,
Minia University
ClinicalTrials.gov Identifier:
NCT05087901
Other Study ID Numbers:
- 34:3/2021
First Posted:
Oct 21, 2021
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No