Effect of Intraocular Tamponade on Visual Perception

Not Applicable

Recruiting

• Conditions: Retinal Detachment; Optic Neuropathy; Glaucoma
• Interventions: Diagnostic Test: Electroretinogram; Procedure: Vitrectomy operation

• Registration Number: NCT05543018
• Lead Sponsor: Benha University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-12
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-13
• Last Update Submitted: 2022-09-13
• Study First Posted: 2022-09-16
• Last Update Posted: 2022-09-16
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-expansile gas	Electroretinogram	Patients diagnosed with retinal detachment and undergone vitrectomy operation with non-expansile gas tamponade (sulfur hexafluoride).
Silicon oil group	Vitrectomy operation	Patients diagnosed with retinal detachment and undergone vitrectomy operation with silicon oil tamponade.
Air tamponade	Electroretinogram	Patients diagnosed with retinal detachment and undergone vitrectomy operation with air tamponade.
Non-expansile gas	Vitrectomy operation	Patients diagnosed with retinal detachment and undergone vitrectomy operation with non-expansile gas tamponade (sulfur hexafluoride).
Silicon oil group	Electroretinogram	Patients diagnosed with retinal detachment and undergone vitrectomy operation with silicon oil tamponade.
Air tamponade	Vitrectomy operation	Patients diagnosed with retinal detachment and undergone vitrectomy operation with air tamponade.

Primary Outcome Measures

Name	Time	Method
Retinal function implicit time.	Baseline and monthly after surgery till 6 months of follow up.	Changes in electroretinogram implicit time in millisecond measured by roland consult retinal function device.
Visual acuity	Baseline and monthly after surgery till 6 months of follow up.	Changes in visual acuity measured in LogMAR units.
Retinal function amplitude	Baseline and monthly after surgery till 6 months of follow up.	Changes in electroretinogram amplitude parameters in microvolt/second measured by roland consult retinal function device.

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure	Baseline and monthly after surgery till 6 months of follow up.	Changes in intraocular pressure measured by goldman applanation tonometry in millimeter mercury.

Trial Locations

Locations (1)

Ahmed Abdelshafy Tabl; 🇪🇬 Banhā, Benha, Egypt