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Effect of Intraocular Tamponade on Visual Perception

Primary Purpose

Retinal Detachment, Optic Neuropathy, Glaucoma

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Electroretinogram

Vitrectomy operation

About this trial

This is an interventional treatment trial for Retinal Detachment focused on measuring Vitrectomy, Retinal detachment, Intraocular Tamponade, Silicon oil, Air tamponade

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Ahmed Abdelshafy TablRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Silicon oil group

Air tamponade

Non-expansile gas

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Visual acuity

Changes in visual acuity measured in LogMAR units.

Retinal function amplitude

Changes in electroretinogram amplitude parameters in microvolt/second measured by roland consult retinal function device.

Retinal function implicit time.

Changes in electroretinogram implicit time in millisecond measured by roland consult retinal function device.

Secondary Outcome Measures

Intraocular pressure

Changes in intraocular pressure measured by goldman applanation tonometry in millimeter mercury.

Full Information

NCT ID

NCT05543018

First Posted

September 12, 2022

Last Updated

September 13, 2022

Sponsor

Benha University

1. Study Identification

Unique Protocol Identification Number

NCT05543018

Brief Title

Effect of Intraocular Tamponade on Visual Perception

Official Title

Effect of Intraocular Tamponade on Visual Function in the Human Eyes

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 12, 2022 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

October 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Detachment, Optic Neuropathy, Glaucoma

Keywords

Vitrectomy, Retinal detachment, Intraocular Tamponade, Silicon oil, Air tamponade

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Silicon oil group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Air tamponade

Arm Type

Active Comparator

Arm Description

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

Arm Title

Non-expansile gas

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Electroretinogram

Intervention Description

Retinal function assessment using electroretinogram

Intervention Type

Procedure

Intervention Name(s)

Vitrectomy operation

Intervention Description

Vitrectomy operation to treat retinal detachment

Primary Outcome Measure Information:

Title

Visual acuity

Description

Changes in visual acuity measured in LogMAR units.

Time Frame

Baseline and monthly after surgery till 6 months of follow up.

Title

Retinal function amplitude

Description

Changes in electroretinogram amplitude parameters in microvolt/second measured by roland consult retinal function device.

Time Frame

Baseline and monthly after surgery till 6 months of follow up.

Title

Retinal function implicit time.

Description

Changes in electroretinogram implicit time in millisecond measured by roland consult retinal function device.

Time Frame

Baseline and monthly after surgery till 6 months of follow up.

Secondary Outcome Measure Information:

Title

Intraocular pressure

Description

Changes in intraocular pressure measured by goldman applanation tonometry in millimeter mercury.

Time Frame

Baseline and monthly after surgery till 6 months of follow up.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed A Tabl, MD

Phone

01222328766

ahmad4lg@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed A Tabl, MD

Organizational Affiliation

Benha University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ahmed Abdelshafy Tabl

City

Banhā

State/Province

Benha

ZIP/Postal Code

13511

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed A Tabl

Phone

01222328766

ahmad4lg@gmail.com

First Name & Middle Initial & Last Name & Degree

Marwa Abdelshafy, MD

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Intraocular Tamponade on Visual Perception

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