Effect of Intraocular Tamponade on Visual Function in the Human Eyes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Benha University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Retinal function implicit time.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Non-expansile gas
Patients diagnosed with retinal detachment and undergone vitrectomy operation with non-expansile gas tamponade (sulfur hexafluoride).
Intervention: Vitrectomy operation (Procedure)
Non-expansile gas
Patients diagnosed with retinal detachment and undergone vitrectomy operation with non-expansile gas tamponade (sulfur hexafluoride).
Intervention: Electroretinogram (Diagnostic Test)
Silicon oil group
Patients diagnosed with retinal detachment and undergone vitrectomy operation with silicon oil tamponade.
Intervention: Electroretinogram (Diagnostic Test)
Silicon oil group
Patients diagnosed with retinal detachment and undergone vitrectomy operation with silicon oil tamponade.
Intervention: Vitrectomy operation (Procedure)
Air tamponade
Patients diagnosed with retinal detachment and undergone vitrectomy operation with air tamponade.
Intervention: Electroretinogram (Diagnostic Test)
Air tamponade
Patients diagnosed with retinal detachment and undergone vitrectomy operation with air tamponade.
Intervention: Vitrectomy operation (Procedure)
Outcomes
Primary Outcomes
Retinal function implicit time.
Time Frame: 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
Time Frame: Baseline and monthly after surgery till 6 months of follow up.
Changes in visual acuity measured in LogMAR units.
Retinal function amplitude
Time Frame: 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 Outcomes
- Intraocular pressure(Baseline and monthly after surgery till 6 months of follow up.)
Investigators
Ahmed Abdelshafy
Lecturer of Ophthalmology
Benha University