Effect of Intraocular Tamponade on Visual Perception

Sponsor

Benha University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05543018

Collaborator

(none)

Enrollment

Location

Arms

13.5

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Retinal Detachment Optic Neuropathy Glaucoma	Diagnostic Test: Electroretinogram Procedure: Vitrectomy operation	N/A

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

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Intraocular Tamponade on Visual Function in the Human Eyes

Actual Study Start Date :

Sep 12, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Oct 28, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Silicon oil group

Patients diagnosed with retinal detachment and undergone vitrectomy operation with silicon oil tamponade.

Diagnostic Test: Electroretinogram

Retinal function assessment using electroretinogram

Procedure: Vitrectomy operation

Vitrectomy operation to treat retinal detachment

Active Comparator: Air tamponade

Patients diagnosed with retinal detachment and undergone vitrectomy operation with air tamponade.

Diagnostic Test: Electroretinogram

Retinal function assessment using electroretinogram

Procedure: Vitrectomy operation

Vitrectomy operation to treat retinal detachment

Active Comparator: Non-expansile gas

Patients diagnosed with retinal detachment and undergone vitrectomy operation with non-expansile gas tamponade (sulfur hexafluoride).

Diagnostic Test: Electroretinogram

Retinal function assessment using electroretinogram

Procedure: Vitrectomy operation

Vitrectomy operation to treat retinal detachment

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.