NCT05543018

Brief Summary

Intraocular tamponade used in vitrectomy operations may affects retinal function in various mechanisms.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

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

First Submitted

Initial submission to the registry

September 12, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 12, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2023

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

September 12, 2022

Last Update Submit

September 13, 2022

Conditions

Retinal DetachmentOptic NeuropathyGlaucoma

Keywords

VitrectomyRetinal detachmentIntraocular TamponadeSilicon oilAir tamponade

Outcome Measures

Primary Outcomes (3)

  • Visual acuity

    Changes in visual acuity measured in LogMAR units.

    Baseline and monthly after surgery till 6 months of follow up.

  • Retinal function amplitude

    Changes in electroretinogram amplitude parameters in microvolt/second measured by roland consult retinal function device.

    Baseline and monthly after surgery till 6 months of follow up.

  • Retinal function implicit time.

    Changes in electroretinogram implicit time in millisecond measured by roland consult retinal function device.

    Baseline and monthly after surgery till 6 months of follow up.

Secondary Outcomes (1)

  • Intraocular pressure

    Baseline and monthly after surgery till 6 months of follow up.

Study Arms (3)

Silicon oil group

ACTIVE COMPARATOR

Patients diagnosed with retinal detachment and undergone vitrectomy operation with silicon oil tamponade.

Diagnostic Test: ElectroretinogramProcedure: Vitrectomy operation

Air tamponade

ACTIVE COMPARATOR

Patients diagnosed with retinal detachment and undergone vitrectomy operation with air tamponade.

Diagnostic Test: ElectroretinogramProcedure: Vitrectomy operation

Non-expansile gas

ACTIVE COMPARATOR

Patients diagnosed with retinal detachment and undergone vitrectomy operation with non-expansile gas tamponade (sulfur hexafluoride).

Diagnostic Test: ElectroretinogramProcedure: Vitrectomy operation

Interventions

ElectroretinogramDIAGNOSTIC_TEST

Retinal function assessment using electroretinogram

Air tamponadeNon-expansile gasSilicon oil group
Vitrectomy operationPROCEDURE

Vitrectomy operation to treat retinal detachment

Air tamponadeNon-expansile gasSilicon oil group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary retinal detachment patients.
  • patients eligible for 23 gauge pars-plana vitrectomy operation.

You may not qualify if:

  • patients with axial length more than 30 millimeter that may have severe chorioretinal degenerations that may affects retinal function.
  • patients with macular diseases that may affects final visual outcome as macular holes and choroidal neovascular membranes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdelshafy Tabl

Banhā, Benha, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Retinal DetachmentOptic Nerve DiseasesGlaucoma

Interventions

Electroretinography

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesCranial Nerve DiseasesNervous System DiseasesOcular Hypertension

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Ahmed A Tabl, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Tabl, MD

CONTACT

01222328766ahmad4lg@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 16, 2022

Study Start

September 12, 2022

Primary Completion

September 30, 2023

Study Completion

October 28, 2023

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)