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NCT05543018 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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.
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