Effect of Intraocular Tamponade on Visual Perception

Study Overview
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Brief Summary
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Intraocular tamponade used in vitrectomy operations may affects retinal function in various mechanisms.

Detailed Description
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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.

Official Title
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Effect of Intraocular Tamponade on Visual Function in the Human Eyes

Conditions
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Retinal Detachment, Optic Neuropathy, Glaucoma

Intervention / Treatment
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* Diagnostic Test: Electroretinogram
* Procedure: Vitrectomy operation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Silicon oil group<br>Patients diagnosed with retinal detachment and undergone vitrectomy operation with silicon oil tamponade. | Diagnostic Test: Electroretinogram<br>* Retinal function assessment using electroretinogram<br>Procedure: Vitrectomy operation<br>* Vitrectomy operation to treat retinal detachment<br>|
| Active Comparator: Air tamponade<br>Patients diagnosed with retinal detachment and undergone vitrectomy operation with air tamponade. | Diagnostic Test: Electroretinogram<br>* Retinal function assessment using electroretinogram<br>Procedure: Vitrectomy operation<br>* Vitrectomy operation to treat retinal detachment<br>|
| Active Comparator: Non-expansile gas<br>Patients diagnosed with retinal detachment and undergone vitrectomy operation with non-expansile gas tamponade (sulfur hexafluoride). | Diagnostic Test: Electroretinogram<br>* Retinal function assessment using electroretinogram<br>Procedure: Vitrectomy operation<br>* Vitrectomy operation to treat retinal detachment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitrectomy, Retinal detachment, Intraocular Tamponade, Silicon oil, Air tamponade