Effect of Intraocular Tamponade on Visual Perception

Glaucoma Clinical Trial

Official title:

Effect of Intraocular Tamponade on Visual Function in the Human Eyes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05543018
• Other study ID #: RC-10-22
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: October 28, 2023

Study information

• Verified date: September 2022
• Source: Benha University
• Contact: Ahmed A Tabl, MD
• Phone: 01222328766
• Email: ahmad4lg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Various intraocular tamponade are being used in vitrectomy operations as gases, fluids and silicon oil. The effects of these intraocular tamponade may affects the final visual outcome of the surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 28, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Glaucoma
• Optic Nerve Diseases
• Optic Neuropathy
• Retinal Detachment

Intervention

Diagnostic Test:
• Electroretinogram
Retinal function assessment using electroretinogram

Procedure:
• Vitrectomy operation
Vitrectomy operation to treat retinal detachment

Locations

Country	Name	City	State
Egypt	Ahmed Abdelshafy Tabl	Banha	Benha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Changes in visual acuity measured in LogMAR units.	Baseline and monthly after surgery till 6 months of follow up.
Primary	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.
Primary	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	Intraocular pressure	Changes in intraocular pressure measured by goldman applanation tonometry in millimeter mercury.	Baseline and monthly after surgery till 6 months of follow up.