NCT05087901

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

October 9, 2021

Last Update Submit

October 9, 2021

Conditions

Silicone Oil Filled Eyes

Outcome Measures

Primary Outcomes (1)

  • Change in Amplitude

    Change in amplitudes of P1 and N1 waves before and after silicone oil removal

    Preoperative and 1 month postoperative recordings

Study Arms (1)

Silicone-filled eyes

Diagnostic Test: Multifocal electroretinogram

Interventions

Multifocal electroretinogramDIAGNOSTIC_TEST

A device that records electric potentials generated by the retinal photoreceptors and neural elements in a multifocal fashion

Silicone-filled eyes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 30 patients will be recruited. We will include patients 18 years of age or older who underwent PPV for the repair of rhegmatogenous retinal detachment (RRD) and received silicone oil as an intraocular tamponade. 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University Hospital

Minya, 61111, Egypt

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 9, 2021

First Posted

October 21, 2021

Study Start

October 1, 2021

Primary Completion

January 31, 2022

Study Completion

March 31, 2022

Last Updated

October 21, 2021

Record last verified: 2021-10

Locations

EG(1)